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S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer

Primary Purpose

Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ziv-aflibercept
topotecan hydrochloride
Sponsored by
National Cancer Institute (NCI)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Extensive Stage Small Cell Lung Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Histologically or cytologically confirmed extensive stage small cell lung cancer

    • Progressive or recurrent disease following one (and only one) standard first-line platinum-containing regimen (cisplatin or carboplatin)

  • Measurable or non-measurable disease per RECIST criteria

    • Disease must be outside a previously irradiated field OR a new lesion must be inside the irradiated field
    • Disease must be outside a previously resected area OR a new lesion must be present
  • No known brain metastasis unless the metastasis has been treated and is stable for ≥ 3 months prior to study entry
  • No leptomeningeal involvement or brain stem metastasis
  • Zubrod performance status 0-1
  • ANC ≥ 1,500/mm^3
  • Platelet count ≥ 100,000/mm^3
  • Hemoglobin ≥ 10 g/dL
  • Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 60 mL/min
  • Urine protein: creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection
  • Not pregnant or nursing
  • Fertile patients must use effective contraception
  • Willing to provide smoking history
  • No evidence of active infection
  • No active bleeding
  • No significant history of bleeding diathesis, including hemoptysis (½ teaspoon of hemoptysis within the past 3 months), or underlying coagulopathy

  • No history of recent arterial embolic events, including any of the following:

    • Myocardial infarction
    • Cerebrovascular accident
    • Transient ischemic attack
    • Worsening of pre-existing angina within the past 6 months

  • No uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg)

    • History of hypertension allowed provided it is controlled on anti-hypertensive medications
  • No history of congestive heart failure
  • No history of encephalitis or encephalopathy of any cause
  • No diverticulitis, gastrointestinal bleeding, or peptic ulcer within the past 3 months
  • No known AIDS or HIV-1 associated complex
  • No known history of immune or immunodeficiency disorders
  • No unstable or pre-existing major medical conditions except for cancer-related abnormalities

  • No other prior malignancy except for any of the following:

    • Adequately treated basal cell or squamous cell skin cancer
    • In situ cervical cancer
    • Adequately treated stage I or II cancer currently in complete remission
    • Any other cancer from which the patient been disease-free for 5 years
  • Concurrent chronic therapeutic doses of low molecular weight heparin allowed
  • At least 21 days since prior and no concurrent radiotherapy and recovered
  • At least 28 days since prior and no concurrent surgery (e.g., thoracic or other major surgeries) and recovered
  • No prior bevacizumab or other anti-angiogenic therapies including, but not limited to, small molecule tyrosine kinase inhibitors

  • No concurrent enzyme-inducing anticonvulsant drugs

    • Non-enzyme-inducing anticonvulsant drugs (e.g., Keppra) allowed
  • Concurrent chronic oral anticoagulation therapy allowed provided INR is maintained in the therapeutic range (INR 2-3)

Sites / Locations

  • Northeast Alabama Regional Medical Center
  • Providence Hospital
  • Arizona Cancer Center at UMC Orange Grove
  • Arizona Cancer Center at University Medical Center North
  • University of Arizona Health Sciences Center
  • NEA Baptist Memorial Hospital
  • University of Arkansas for Medical Sciences
  • Highlands Oncology Group-Rogers
  • East Bay Radiation Oncology Center
  • Eden Hospital Medical Center
  • Valley Medical Oncology Consultants-Castro Valley
  • City of Hope Medical Center
  • Valley Medical Oncology Consultants-Fremont
  • Contra Costa Regional Medical Center
  • Fremont - Rideout Cancer Center
  • El Camino Hospital
  • Highland General Hospital
  • Alta Bates Summit Medical Center - Summit Campus
  • Bay Area Breast Surgeons Inc
  • Bay Area Tumor Institute CCOP
  • Larry G Strieff MD Medical Corporation
  • Tom K Lee Inc
  • Valley Care Health System - Pleasanton
  • Valley Medical Oncology Consultants
  • University of California at Davis Cancer Center
  • Doctors Medical Center- JC Robinson Regional Cancer Center
  • San Luis Valley Regional Medical Center
  • University of Colorado Cancer Center - Anschutz Cancer Pavilion
  • The Shaw Regional Cancer Center
  • Valley View Hospital Cancer Center
  • Saint Mary's Hospital and Regional Medical Center
  • Montrose Memorial Hospital
  • Saint Francis Hospital and Medical Center
  • Piedmont Hospital
  • Atlanta Regional CCOP
  • Northside Hospital
  • Saint Joseph's Hospital of Atlanta
  • Well Star Cobb Hospital
  • John B Amos Cancer Center
  • Dekalb Medical Center
  • Piedmont Fayette Hospital
  • Gwinnett Medical Center
  • Wellstar Kennestone Hospital
  • Southern Regional Medical Center
  • Harbin Clinic Medical Oncology and Clinical Research
  • Memorial Health University Medical Center
  • South Georgia Medical Center
  • Saint Alphonsus Regional Medical Center
  • Saint Anthony's Health
  • Cancer Care Center of Decatur
  • Decatur Memorial Hospital
  • Loyola University Medical Center
  • Good Samaritan Regional Health Center
  • Memorial Medical Center
  • Saint Francis Hospital and Health Centers
  • Reid Hospital and Health Care Services
  • Genesis Medical Center - East Campus
  • Genesis Medical Center - West Campus
  • Hospital District Sixth of Harper County
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Hays Medical Center
  • Promise Regional Medical Center-Hutchinson
  • Cancer Center of Kansas-Independence
  • Kansas City Cancer Center-West
  • University of Kansas Medical Center
  • Cancer Center of Kansas-Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas-Liberal
  • Cancer Center of Kansas - Newton
  • Olathe Cancer Center
  • Cancer Center of Kansas - Parsons
  • Via Christi Hospital-Pittsburg
  • Cancer Center of Kansas - Pratt
  • Cancer Center of Kansas - Salina
  • Salina Regional Health Center
  • Stormont-Vail Regional Health Center
  • Saint Francis Hospital and Medical Center - Topeka
  • Cancer Center of Kansas - Wellington
  • Associates In Womens Health
  • Cancer Center of Kansas-Wichita Medical Arts Tower
  • Cancer Center of Kansas - Main Office
  • Via Christi Regional Medical Center
  • Wichita CCOP
  • Cancer Center of Kansas - Winfield
  • University of Kentucky
  • Baton Rouge General Medical Center
  • Mary Bird Perkins Cancer Center
  • Interim LSU Public Hospital
  • Louisiana State University Health Science Center
  • Sinai Hospital of Baltimore
  • Boston Medical Center
  • Lahey Hospital and Medical Center
  • Holy Family Hospital
  • Saint Joseph Mercy Hospital
  • Michigan Cancer Research Consortium Community Clinical Oncology Program
  • University of Michigan
  • Bronson Battle Creek
  • Spectrum Health Big Rapids Hospital
  • Oakwood Hospital
  • Wayne State University/Karmanos Cancer Institute
  • Saint John Hospital and Medical Center
  • Hurley Medical Center
  • Genesys Regional Medical Center-West Flint Campus
  • Grand Rapids Clinical Oncology Program
  • Mercy Health Saint Mary's
  • Spectrum Health at Butterworth Campus
  • Allegiance Health
  • Sparrow Hospital
  • Saint Mary Mercy Hospital
  • Mercy Health Mercy Campus
  • Saint Joseph Mercy Oakland
  • Saint Joseph Mercy Port Huron
  • Saint Mary's of Michigan
  • Munson Medical Center
  • Saint John Macomb-Oakland Hospital
  • Metro Health Hospital
  • Gulfport Memorial Hospital
  • University of Mississippi Medical Center
  • Singing River Hospital
  • Saint Francis Medical Center
  • Truman Medical Center
  • Kansas City Veterans Affairs Medical Center
  • Saint Louis Cancer and Breast Institute-South City
  • Saint Louis University Hospital
  • Saint John's Mercy Medical Center
  • Saint Louis-Cape Girardeau CCOP
  • Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
  • Mercy Hospital Springfield
  • CoxHealth South Hospital
  • Montana Cancer Consortium CCOP
  • Northern Rockies Radiation Oncology Center
  • Saint Vincent Healthcare
  • Hematology-Oncology Centers of the Northern Rockies PC
  • Billings Clinic
  • Bozeman Deaconess Cancer Center
  • Bozeman Deaconess Hospital
  • Saint James Community Hospital and Cancer Treatment Center
  • Benefis Healthcare- Sletten Cancer Institute
  • Berdeaux, Donald MD (UIA Investigator)
  • Big Sky Oncology
  • Great Falls Clinic
  • Northern Montana Hospital
  • Saint Peter's Community Hospital
  • Glacier Oncology PLLC
  • Kalispell Medical Oncology
  • Kalispell Regional Medical Center
  • Community Medical Hospital
  • Montana Cancer Specialists
  • Saint Patrick Hospital - Community Hospital
  • Guardian Oncology and Center for Wellness
  • University Medical Center of Southern Nevada
  • Nevada Cancer Research Foundation CCOP
  • Arnot Ogden Medical Center
  • Adirondack Cancer Center
  • Winthrop University Hospital
  • Columbia University Medical Center
  • Highland Hospital
  • Interlakes Foundation Inc-Rochester
  • University of Rochester
  • Randolph Hospital
  • Carolinas Medical Center
  • Novant Health Presbyterian Medical Center
  • Carolinas Medical Center - Northeast
  • Gaston Memorial Hospital
  • Wayne Memorial Hospital
  • Cone Health Cancer Center
  • Margaret R Pardee Memorial Hospital
  • High Point Regional Hospital
  • Annie Penn Memorial Hospital
  • Rutherford Hospital
  • Iredell Memorial Hospital
  • Akron General Medical Center
  • Mary Rutan Hospital
  • Adena Regional Medical Center
  • University of Cincinnati
  • Riverside Methodist Hospital
  • Columbus CCOP
  • Grant Medical Center
  • Mount Carmel Health Center West
  • Doctors Hospital
  • Grandview Hospital
  • Good Samaritan Hospital - Dayton
  • Miami Valley Hospital
  • Samaritan North Health Center
  • Dayton CCOP
  • Grady Memorial Hospital
  • Blanchard Valley Hospital
  • Atrium Medical Center-Middletown Regional Hospital
  • Wayne Hospital
  • Kettering Medical Center
  • Fairfield Medical Center
  • Marietta Memorial Hospital
  • Knox Community Hospital
  • Licking Memorial Hospital
  • Southern Ohio Medical Center
  • Springfield Regional Medical Center
  • Upper Valley Medical Center
  • Saint Ann's Hospital
  • Clinton Memorial Hospital
  • Wright-Patterson Medical Center
  • Greene Memorial Hospital
  • Genesis HealthCare System
  • Clackamas Radiation Oncology Center
  • Providence Milwaukie Hospital
  • Providence Newberg Medical Center
  • Providence Willamette Falls Medical Center
  • Providence Portland Medical Center
  • Western Oncology Research Consortium
  • Adventist Medical Center
  • Providence Saint Vincent Medical Center
  • Oregon Health and Science University
  • Salem Hospital
  • AnMed Health Hospital
  • McLeod Regional Medical Center
  • Spartanburg Regional Medical Center
  • Upstate Carolina CCOP
  • University of Tennessee - Knoxville
  • Veterans Affairs Medical Center - Memphis
  • University of Tennessee - Memphis
  • University of Texas Medical Branch at Galveston
  • Baylor College of Medicine
  • Ben Taub General Hospital
  • Methodist Hospital
  • Saint Luke's Episcopal Hospital
  • Veterans Administration Medical Center
  • Texas Tech University Health Sciences Center
  • Southwest Oncology Group
  • Scott and White Memorial Hospital
  • Huntsman Cancer Institute/University of Utah
  • Danville Regional Medical Center
  • Memorial Hospital Of Martinsville
  • Cancer Care Center at Island Hospital
  • PeaceHealth Saint Joseph Medical Center
  • Harrison HealthPartners Hematology and Oncology-Bremerton
  • Highline Medical Center-Main Campus
  • Columbia Basin Hematology and Oncology PLLC
  • Skagit Valley Hospital
  • Harrison HealthPartners Hematology and Oncology-Poulsbo
  • Harborview Medical Center
  • Minor and James Medical PLLC
  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  • Group Health Cooperative-Seattle
  • Swedish Medical Center-First Hill
  • The Polyclinic
  • University of Washington Medical Center
  • United General Hospital
  • Cancer Care Northwest - Spokane South
  • Evergreen Hematology and Oncology PS
  • Rockwood Clinic
  • PeaceHealth Southwest Medical Center
  • Compass Oncology Vancouver
  • Wenatchee Valley Medical Center
  • Rocky Mountain Oncology
  • Welch Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm I (ziv-aflibercept, topotecan hydrochloride)

Arm II (topotecan hydrochloride)

Arm Description

Patients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression-free Survival (PFS)
From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.

Secondary Outcome Measures

Overall Survival
Estimated to within at least 15% (95% confidence interval).
Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)
The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event.

Full Information

First Posted
January 22, 2009
Last Updated
July 21, 2017
Sponsor
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00828139
Brief Title
S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer
Official Title
A Randomized Phase II Trial of Weekly Topotecan With and Without AVE0005 (Aflibercept; NSC-724770) in Patients With Platinum Treated Extensive Stage Small Cell Lung Cancer (E-SCLC)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
This randomized phase II trial is studying topotecan to see how well it works when given with or without aflibercept in treating patients with extensive-stage small cell lung cancer. Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Combinations of biological substances in aflibercept may be able to carry tumor-killing substances directly to small cell lung cancer cells. Aflibercept may also stop the growth of small cell lung cancer by blocking blood flow to the tumor. It is not yet known whether topotecan is more effective with or without aflibercept in treating patients with small cell lung cancer.
Detailed Description
PRIMARY OBJECTIVES: I. Evaluate the efficacy of topotecan hydrochloride with vs without aflibercept (ziv-aflibercept), in terms of progression-free survival at 3 months, in patients with extensive stage small cell lung cancer previously treated with platinum-based therapy. SECONDARY OBEJCTIVES: I. Assess the response rate (confirmed and unconfirmed, complete and partial responses) in a subset of patients with measurable disease. II. Assess the overall survival of these patients. III. Evaluate the frequency and severity of toxicities of these regimens in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to response to prior platinum-based therapy (platinum-sensitive disease vs platinum-refractory disease). Patients are randomized to 1 of 2 treatment arms. ARM I: Patients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. ARM II: Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study therapy, patients are followed periodically for up to 2 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Extensive Stage Small Cell Lung Cancer, Recurrent Small Cell Lung Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
189 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (ziv-aflibercept, topotecan hydrochloride)
Arm Type
Experimental
Arm Description
Patients receive ziv-aflibercept IV over 1 hour on day 1 and topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive ziv-aflibercept IV on day 1 and topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Arm Title
Arm II (topotecan hydrochloride)
Arm Type
Active Comparator
Arm Description
Patients receive topotecan hydrochloride IV over 30 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with responsive or stable disease after 4 courses may then receive topotecan hydrochloride IV on days 1 and 8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Biological
Intervention Name(s)
ziv-aflibercept
Other Intervention Name(s)
aflibercept, vascular endothelial growth factor trap, VEGF Trap, Zaltrap
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
topotecan hydrochloride
Other Intervention Name(s)
hycamptamine, Hycamtin, SKF S-104864-A, TOPO
Intervention Description
Given IV
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
From the date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Progression is defined as 20% increase in the sum of longest diameters of target measurable lesions over smallest sum observed (over baseline if no decrease during therapy) using the same techniques as baseline. Unequivocal progression of non-measurable disease in the opinion of the treating physician (an explanation must be provided). Appearance of any new lesion/site. Death due to disease without prior documentation of progression and without symptomatic deterioration.
Time Frame
Disease assessments were performed every 6 weeks, up to 2 years.
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Estimated to within at least 15% (95% confidence interval).
Time Frame
Weekly, up to 2 years.
Title
Response Rate (Confirmed and Unconfirmed, Complete and Partial Responses)
Description
The number of confirmed and unconfirmed complete and partial responses in the subset of patients with measurable disease per RECIST 1.0. Estimated to within at least 17% (95% confidence interval). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by magnetic resonance imaging (MRI): Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.
Time Frame
Disease assessment for response were performed every 6 weeks, up to 2 years.
Title
Number of Patients With Grade 3 Through 5 Adverse Events That Are Related to Study Drugs
Description
Adverse Events (AEs) are reported by CTCAE Version 3.0. Only adverse events that are possibly, probably or definitely related to study drug are reported. The events listed here are not necessary to be included in Serious Adverse Event. A serious event could be death, life-threatening, hospitalization, disability or permanent damage, congenital anomaly...Grade 3 through 5 adverse event may not meet the criterion of serious adverse event.
Time Frame
Toxicity assessment was evaluated after each cycle (21 days), up to 2 years.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed extensive stage small cell lung cancer Progressive or recurrent disease following one (and only one) standard first-line platinum-containing regimen (cisplatin or carboplatin) Measurable or non-measurable disease per RECIST criteria Disease must be outside a previously irradiated field OR a new lesion must be inside the irradiated field Disease must be outside a previously resected area OR a new lesion must be present No known brain metastasis unless the metastasis has been treated and is stable for ≥ 3 months prior to study entry No leptomeningeal involvement or brain stem metastasis Zubrod performance status 0-1 ANC ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL Serum creatinine ≤ 1.5 times upper limit of normal OR creatinine clearance ≥ 60 mL/min Urine protein: creatinine ratio < 1 OR urine protein < 500 mg by 24-hour urine collection Not pregnant or nursing Fertile patients must use effective contraception Willing to provide smoking history No evidence of active infection No active bleeding No significant history of bleeding diathesis, including hemoptysis (½ teaspoon of hemoptysis within the past 3 months), or underlying coagulopathy No history of recent arterial embolic events, including any of the following: Myocardial infarction Cerebrovascular accident Transient ischemic attack Worsening of pre-existing angina within the past 6 months No uncontrolled hypertension (systolic BP > 150 mm Hg or diastolic BP > 100 mm Hg) History of hypertension allowed provided it is controlled on anti-hypertensive medications No history of congestive heart failure No history of encephalitis or encephalopathy of any cause No diverticulitis, gastrointestinal bleeding, or peptic ulcer within the past 3 months No known AIDS or HIV-1 associated complex No known history of immune or immunodeficiency disorders No unstable or pre-existing major medical conditions except for cancer-related abnormalities No other prior malignancy except for any of the following: Adequately treated basal cell or squamous cell skin cancer In situ cervical cancer Adequately treated stage I or II cancer currently in complete remission Any other cancer from which the patient been disease-free for 5 years Concurrent chronic therapeutic doses of low molecular weight heparin allowed At least 21 days since prior and no concurrent radiotherapy and recovered At least 28 days since prior and no concurrent surgery (e.g., thoracic or other major surgeries) and recovered No prior bevacizumab or other anti-angiogenic therapies including, but not limited to, small molecule tyrosine kinase inhibitors No concurrent enzyme-inducing anticonvulsant drugs Non-enzyme-inducing anticonvulsant drugs (e.g., Keppra) allowed Concurrent chronic oral anticoagulation therapy allowed provided INR is maintained in the therapeutic range (INR 2-3)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeffrey Allen
Organizational Affiliation
SWOG Cancer Research Network
Official's Role
Principal Investigator
Facility Information:
Facility Name
Northeast Alabama Regional Medical Center
City
Anniston
State/Province
Alabama
ZIP/Postal Code
36202
Country
United States
Facility Name
Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Arizona Cancer Center at UMC Orange Grove
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
Arizona Cancer Center at University Medical Center North
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85719
Country
United States
Facility Name
University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
NEA Baptist Memorial Hospital
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
University of Arkansas for Medical Sciences
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Highlands Oncology Group-Rogers
City
Rogers
State/Province
Arkansas
ZIP/Postal Code
72758
Country
United States
Facility Name
East Bay Radiation Oncology Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Eden Hospital Medical Center
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
Valley Medical Oncology Consultants-Castro Valley
City
Castro Valley
State/Province
California
ZIP/Postal Code
94546
Country
United States
Facility Name
City of Hope Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Facility Name
Valley Medical Oncology Consultants-Fremont
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Contra Costa Regional Medical Center
City
Martinez
State/Province
California
ZIP/Postal Code
94553-3156
Country
United States
Facility Name
Fremont - Rideout Cancer Center
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Facility Name
El Camino Hospital
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Highland General Hospital
City
Oakland
State/Province
California
ZIP/Postal Code
94602
Country
United States
Facility Name
Alta Bates Summit Medical Center - Summit Campus
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Breast Surgeons Inc
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Bay Area Tumor Institute CCOP
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Larry G Strieff MD Medical Corporation
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Tom K Lee Inc
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Valley Care Health System - Pleasanton
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
Valley Medical Oncology Consultants
City
Pleasanton
State/Province
California
ZIP/Postal Code
94588
Country
United States
Facility Name
University of California at Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
Doctors Medical Center- JC Robinson Regional Cancer Center
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
San Luis Valley Regional Medical Center
City
Alamosa
State/Province
Colorado
ZIP/Postal Code
81101
Country
United States
Facility Name
University of Colorado Cancer Center - Anschutz Cancer Pavilion
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
The Shaw Regional Cancer Center
City
Edwards
State/Province
Colorado
ZIP/Postal Code
81632
Country
United States
Facility Name
Valley View Hospital Cancer Center
City
Glenwood Springs
State/Province
Colorado
ZIP/Postal Code
81601
Country
United States
Facility Name
Saint Mary's Hospital and Regional Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
Montrose Memorial Hospital
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Atlanta Regional CCOP
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Northside Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Saint Joseph's Hospital of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Well Star Cobb Hospital
City
Austell
State/Province
Georgia
ZIP/Postal Code
30106
Country
United States
Facility Name
John B Amos Cancer Center
City
Columbus
State/Province
Georgia
ZIP/Postal Code
31904
Country
United States
Facility Name
Dekalb Medical Center
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Piedmont Fayette Hospital
City
Fayetteville
State/Province
Georgia
ZIP/Postal Code
30214
Country
United States
Facility Name
Gwinnett Medical Center
City
Lawrenceville
State/Province
Georgia
ZIP/Postal Code
30045
Country
United States
Facility Name
Wellstar Kennestone Hospital
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Southern Regional Medical Center
City
Riverdale
State/Province
Georgia
ZIP/Postal Code
30274
Country
United States
Facility Name
Harbin Clinic Medical Oncology and Clinical Research
City
Rome
State/Province
Georgia
ZIP/Postal Code
30165
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31403
Country
United States
Facility Name
South Georgia Medical Center
City
Valdosta
State/Province
Georgia
ZIP/Postal Code
31603
Country
United States
Facility Name
Saint Alphonsus Regional Medical Center
City
Boise
State/Province
Idaho
ZIP/Postal Code
83706
Country
United States
Facility Name
Saint Anthony's Health
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
Cancer Care Center of Decatur
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Decatur Memorial Hospital
City
Decatur
State/Province
Illinois
ZIP/Postal Code
62526
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Good Samaritan Regional Health Center
City
Mount Vernon
State/Province
Illinois
ZIP/Postal Code
62864
Country
United States
Facility Name
Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Saint Francis Hospital and Health Centers
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Reid Hospital and Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Genesis Medical Center - East Campus
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52803
Country
United States
Facility Name
Genesis Medical Center - West Campus
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52804
Country
United States
Facility Name
Hospital District Sixth of Harper County
City
Anthony
State/Province
Kansas
ZIP/Postal Code
67003
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Fort Scott
City
Fort Scott
State/Province
Kansas
ZIP/Postal Code
66701
Country
United States
Facility Name
Hays Medical Center
City
Hays
State/Province
Kansas
ZIP/Postal Code
67601
Country
United States
Facility Name
Promise Regional Medical Center-Hutchinson
City
Hutchinson
State/Province
Kansas
ZIP/Postal Code
65702
Country
United States
Facility Name
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Kansas City Cancer Center-West
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66112
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
Cancer Center of Kansas-Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Lawrence Memorial Hospital
City
Lawrence
State/Province
Kansas
ZIP/Postal Code
66044
Country
United States
Facility Name
Cancer Center of Kansas-Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Olathe Cancer Center
City
Olathe
State/Province
Kansas
ZIP/Postal Code
66061
Country
United States
Facility Name
Cancer Center of Kansas - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Via Christi Hospital-Pittsburg
City
Pittsburg
State/Province
Kansas
ZIP/Postal Code
66762
Country
United States
Facility Name
Cancer Center of Kansas - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Stormont-Vail Regional Health Center
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66604
Country
United States
Facility Name
Saint Francis Hospital and Medical Center - Topeka
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates In Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas-Wichita Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas - Main Office
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Wichita CCOP
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Baton Rouge General Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70806
Country
United States
Facility Name
Mary Bird Perkins Cancer Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Interim LSU Public Hospital
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Louisiana State University Health Science Center
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
Sinai Hospital of Baltimore
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Lahey Hospital and Medical Center
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
01805
Country
United States
Facility Name
Holy Family Hospital
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Saint Joseph Mercy Hospital
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106-0995
Country
United States
Facility Name
Michigan Cancer Research Consortium Community Clinical Oncology Program
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48106
Country
United States
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Bronson Battle Creek
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Spectrum Health Big Rapids Hospital
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Oakwood Hospital
City
Dearborn
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
Wayne State University/Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Saint John Hospital and Medical Center
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48236
Country
United States
Facility Name
Hurley Medical Center
City
Flint
State/Province
Michigan
ZIP/Postal Code
48502
Country
United States
Facility Name
Genesys Regional Medical Center-West Flint Campus
City
Flint
State/Province
Michigan
ZIP/Postal Code
48532
Country
United States
Facility Name
Grand Rapids Clinical Oncology Program
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mercy Health Saint Mary's
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Spectrum Health at Butterworth Campus
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Allegiance Health
City
Jackson
State/Province
Michigan
ZIP/Postal Code
49201
Country
United States
Facility Name
Sparrow Hospital
City
Lansing
State/Province
Michigan
ZIP/Postal Code
48912
Country
United States
Facility Name
Saint Mary Mercy Hospital
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48154
Country
United States
Facility Name
Mercy Health Mercy Campus
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49444
Country
United States
Facility Name
Saint Joseph Mercy Oakland
City
Pontiac
State/Province
Michigan
ZIP/Postal Code
48341-2985
Country
United States
Facility Name
Saint Joseph Mercy Port Huron
City
Port Huron
State/Province
Michigan
ZIP/Postal Code
48060
Country
United States
Facility Name
Saint Mary's of Michigan
City
Saginaw
State/Province
Michigan
ZIP/Postal Code
48601
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Saint John Macomb-Oakland Hospital
City
Warren
State/Province
Michigan
ZIP/Postal Code
48093
Country
United States
Facility Name
Metro Health Hospital
City
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
Country
United States
Facility Name
Gulfport Memorial Hospital
City
Gulfport
State/Province
Mississippi
ZIP/Postal Code
39502
Country
United States
Facility Name
University of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Singing River Hospital
City
Pascagoula
State/Province
Mississippi
ZIP/Postal Code
39581
Country
United States
Facility Name
Saint Francis Medical Center
City
Cape Girardeau
State/Province
Missouri
ZIP/Postal Code
63703
Country
United States
Facility Name
Truman Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Kansas City Veterans Affairs Medical Center
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64128
Country
United States
Facility Name
Saint Louis Cancer and Breast Institute-South City
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
Saint Louis University Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Saint John's Mercy Medical Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Saint Louis-Cape Girardeau CCOP
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
Mercy Hospital Springfield
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
CoxHealth South Hospital
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
Montana Cancer Consortium CCOP
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Northern Rockies Radiation Oncology Center
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Saint Vincent Healthcare
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies PC
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic
City
Billings
State/Province
Montana
ZIP/Postal Code
59107-7000
Country
United States
Facility Name
Bozeman Deaconess Cancer Center
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Bozeman Deaconess Hospital
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59715
Country
United States
Facility Name
Saint James Community Hospital and Cancer Treatment Center
City
Butte
State/Province
Montana
ZIP/Postal Code
59701
Country
United States
Facility Name
Benefis Healthcare- Sletten Cancer Institute
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Berdeaux, Donald MD (UIA Investigator)
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Great Falls Clinic
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Northern Montana Hospital
City
Havre
State/Province
Montana
ZIP/Postal Code
59501
Country
United States
Facility Name
Saint Peter's Community Hospital
City
Helena
State/Province
Montana
ZIP/Postal Code
59601
Country
United States
Facility Name
Glacier Oncology PLLC
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Medical Oncology
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Kalispell Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Community Medical Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59801
Country
United States
Facility Name
Montana Cancer Specialists
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Saint Patrick Hospital - Community Hospital
City
Missoula
State/Province
Montana
ZIP/Postal Code
59802
Country
United States
Facility Name
Guardian Oncology and Center for Wellness
City
Missoula
State/Province
Montana
ZIP/Postal Code
59804
Country
United States
Facility Name
University Medical Center of Southern Nevada
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89102
Country
United States
Facility Name
Nevada Cancer Research Foundation CCOP
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Arnot Ogden Medical Center
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Facility Name
Adirondack Cancer Center
City
Glens Falls
State/Province
New York
ZIP/Postal Code
12801
Country
United States
Facility Name
Winthrop University Hospital
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Highland Hospital
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Interlakes Foundation Inc-Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14623
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Randolph Hospital
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Carolinas Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28203
Country
United States
Facility Name
Novant Health Presbyterian Medical Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28204
Country
United States
Facility Name
Carolinas Medical Center - Northeast
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Gaston Memorial Hospital
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Facility Name
Wayne Memorial Hospital
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Cone Health Cancer Center
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Margaret R Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
High Point Regional Hospital
City
High Point
State/Province
North Carolina
ZIP/Postal Code
27261
Country
United States
Facility Name
Annie Penn Memorial Hospital
City
Reidsville
State/Province
North Carolina
ZIP/Postal Code
27320
Country
United States
Facility Name
Rutherford Hospital
City
Rutherfordton
State/Province
North Carolina
ZIP/Postal Code
28139
Country
United States
Facility Name
Iredell Memorial Hospital
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Akron General Medical Center
City
Akron
State/Province
Ohio
ZIP/Postal Code
44307
Country
United States
Facility Name
Mary Rutan Hospital
City
Bellefontaine
State/Province
Ohio
ZIP/Postal Code
43311
Country
United States
Facility Name
Adena Regional Medical Center
City
Chillicothe
State/Province
Ohio
ZIP/Postal Code
45601
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Riverside Methodist Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Columbus CCOP
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Grant Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Mount Carmel Health Center West
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43222
Country
United States
Facility Name
Doctors Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43228
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Health Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Dayton CCOP
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Grady Memorial Hospital
City
Delaware
State/Province
Ohio
ZIP/Postal Code
43015
Country
United States
Facility Name
Blanchard Valley Hospital
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
Atrium Medical Center-Middletown Regional Hospital
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005-1066
Country
United States
Facility Name
Wayne Hospital
City
Greenville
State/Province
Ohio
ZIP/Postal Code
45331
Country
United States
Facility Name
Kettering Medical Center
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
Fairfield Medical Center
City
Lancaster
State/Province
Ohio
ZIP/Postal Code
43130
Country
United States
Facility Name
Marietta Memorial Hospital
City
Marietta
State/Province
Ohio
ZIP/Postal Code
45750
Country
United States
Facility Name
Knox Community Hospital
City
Mount Vernon
State/Province
Ohio
ZIP/Postal Code
43050
Country
United States
Facility Name
Licking Memorial Hospital
City
Newark
State/Province
Ohio
ZIP/Postal Code
43055
Country
United States
Facility Name
Southern Ohio Medical Center
City
Portsmouth
State/Province
Ohio
ZIP/Postal Code
45662
Country
United States
Facility Name
Springfield Regional Medical Center
City
Springfield
State/Province
Ohio
ZIP/Postal Code
45505
Country
United States
Facility Name
Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373
Country
United States
Facility Name
Saint Ann's Hospital
City
Westerville
State/Province
Ohio
ZIP/Postal Code
43081
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
Wright-Patterson Medical Center
City
Wright-Patterson Air Force Base
State/Province
Ohio
ZIP/Postal Code
45433-5529
Country
United States
Facility Name
Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Genesis HealthCare System
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Clackamas Radiation Oncology Center
City
Clackamas
State/Province
Oregon
ZIP/Postal Code
97015
Country
United States
Facility Name
Providence Milwaukie Hospital
City
Milwaukie
State/Province
Oregon
ZIP/Postal Code
97222
Country
United States
Facility Name
Providence Newberg Medical Center
City
Newberg
State/Province
Oregon
ZIP/Postal Code
97132
Country
United States
Facility Name
Providence Willamette Falls Medical Center
City
Oregon City
State/Province
Oregon
ZIP/Postal Code
97045
Country
United States
Facility Name
Providence Portland Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Western Oncology Research Consortium
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
Facility Name
Adventist Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97216
Country
United States
Facility Name
Providence Saint Vincent Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
Oregon Health and Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Salem Hospital
City
Salem
State/Province
Oregon
ZIP/Postal Code
97301
Country
United States
Facility Name
AnMed Health Hospital
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
McLeod Regional Medical Center
City
Florence
State/Province
South Carolina
ZIP/Postal Code
29506
Country
United States
Facility Name
Spartanburg Regional Medical Center
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
Upstate Carolina CCOP
City
Spartanburg
State/Province
South Carolina
ZIP/Postal Code
29303
Country
United States
Facility Name
University of Tennessee - Knoxville
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Veterans Affairs Medical Center - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38104
Country
United States
Facility Name
University of Tennessee - Memphis
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38163
Country
United States
Facility Name
University of Texas Medical Branch at Galveston
City
Galveston
State/Province
Texas
ZIP/Postal Code
77555-0565
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Ben Taub General Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Methodist Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Saint Luke's Episcopal Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Veterans Administration Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79430
Country
United States
Facility Name
Southwest Oncology Group
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78245
Country
United States
Facility Name
Scott and White Memorial Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Huntsman Cancer Institute/University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
Memorial Hospital Of Martinsville
City
Martinsville
State/Province
Virginia
ZIP/Postal Code
24115
Country
United States
Facility Name
Cancer Care Center at Island Hospital
City
Anacortes
State/Province
Washington
ZIP/Postal Code
98221
Country
United States
Facility Name
PeaceHealth Saint Joseph Medical Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Bremerton
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Highline Medical Center-Main Campus
City
Burien
State/Province
Washington
ZIP/Postal Code
98166
Country
United States
Facility Name
Columbia Basin Hematology and Oncology PLLC
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Skagit Valley Hospital
City
Mount Vernon
State/Province
Washington
ZIP/Postal Code
98274
Country
United States
Facility Name
Harrison HealthPartners Hematology and Oncology-Poulsbo
City
Poulsbo
State/Province
Washington
ZIP/Postal Code
98370
Country
United States
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Minor and James Medical PLLC
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Group Health Cooperative-Seattle
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Medical Center-First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
The Polyclinic
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
United General Hospital
City
Sedro-Woolley
State/Province
Washington
ZIP/Postal Code
98284
Country
United States
Facility Name
Cancer Care Northwest - Spokane South
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Evergreen Hematology and Oncology PS
City
Spokane
State/Province
Washington
ZIP/Postal Code
99218
Country
United States
Facility Name
Rockwood Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99220
Country
United States
Facility Name
PeaceHealth Southwest Medical Center
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Compass Oncology Vancouver
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98684
Country
United States
Facility Name
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Rocky Mountain Oncology
City
Casper
State/Province
Wyoming
ZIP/Postal Code
82609
Country
United States
Facility Name
Welch Cancer Center
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25490004
Citation
Lara PN Jr, Moon J, Redman MW, Semrad TJ, Kelly K, Allen JW, Gitlitz BJ, Mack PC, Gandara DR. Relevance of platinum-sensitivity status in relapsed/refractory extensive-stage small-cell lung cancer in the modern era: a patient-level analysis of southwest oncology group trials. J Thorac Oncol. 2015 Jan;10(1):110-5. doi: 10.1097/JTO.0000000000000385.
Results Reference
derived
PubMed Identifier
25002722
Citation
Allen JW, Moon J, Redman M, Gadgeel SM, Kelly K, Mack PC, Saba HM, Mohamed MK, Jahanzeb M, Gandara DR. Southwest Oncology Group S0802: a randomized, phase II trial of weekly topotecan with and without ziv-aflibercept in patients with platinum-treated small-cell lung cancer. J Clin Oncol. 2014 Aug 10;32(23):2463-70. doi: 10.1200/JCO.2013.51.4109. Epub 2014 Jul 7.
Results Reference
derived

Learn more about this trial

S0802 - Topotecan With or Without Aflibercept in Treating Patients With Extensive-Stage Small Cell Lung Cancer

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