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A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer

Primary Purpose

Small Cell Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Paclitaxel
Bevacizumab
Sponsored by
Hoosier Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Small Cell Lung Cancer

Eligibility Criteria

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

Inclusion Criteria: Histologic or cytologic proof of small cell lung cancer Chemo-sensitive disease defined as relapsed after 60 days from completion of first line chemotherapy. Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy. Must have received treatment with at least 1 but not more than 2 prior chemotherapy regimens. (At least one regimen must contain a platinum agent. Previous treatment with irinotecan is allowed.) Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration. Prior cancer treatment must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen prior to registration. Exclusion Criteria: No treatment with any investigational agent within 30 days prior to being registered for protocol therapy. No history or radiographic evidence of CNS involvement by head CT or MRI within 42 days prior to registration. No history of seizures, transient ischemic attack or stroke. No clinically significant infections as judged by the treating investigator. No other active cancer except SCLC. No prior treatment with topoisomerase I inhibitor. No contraindications to the use of paclitaxel or bevacizumab as per the investigator's clinical judgment. Must not have grade 3 or greater peripheral neuropathy. Must not have had major surgical procedure, open biopsy, or significant traumatic injury within 28 days of being registered for protocol therapy. No anticipation of need for major surgical procedure during the course of the study. Patients may not have had a minor surgical procedure, placement of an access device or fine needle aspiration within 7 days prior to being registered for protocol therapy. No evidence of bleeding diathesis or coagulopathy. No history of deep vein thrombosis or pulmonary embolism. No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin within 10 days prior to registration. Patients must not have been using aspirin (>325 mg/day) or another nonsteroidal anti-inflammatory medications known to inhibit platelet function on a daily basis within 10 days prior to registration on study. Patients must not be using any of the following drugs known to inhibit platelet function within 10 days prior to registration: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal). Patients must not have a current non-healing wound or fracture. Patients must not have a history of or current hemoptysis.

Sites / Locations

  • Highlands Oncology Group
  • Medical & Surgical Specialists, LLC
  • Cancer Care Center of Southern Indiana
  • Oncology Hematology Associates of SW Indiana
  • Fort Wayne Oncology & Hematology, Inc
  • Center for Cancer Care at Goshen Health System
  • Indiana University Cancer Center
  • Quality Cancer Center (MCGOP)
  • Community Regional Cancer Center
  • Arnett Cancer Care
  • Medical Consultants, P.C.
  • Center for Cancer Care, Inc., P.C.
  • Northern Indiana Cancer Research Consortium
  • Siteman Cancer Center
  • Methodist Cancer Center
  • Pennsylvania Oncology-Hematology Associates
  • Fox Chase Cancer Center Extramural Research Program

Arms of the Study

Arm 1

Arm Type

Active Comparator

Arm Label

1

Arm Description

Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.

Outcomes

Primary Outcome Measures

To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).

Secondary Outcome Measures

To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC.
To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC.
To determine overall survival.
To assess VEGF polymorphisms in the study population.

Full Information

First Posted
April 20, 2006
Last Updated
April 28, 2011
Sponsor
Hoosier Cancer Research Network
Collaborators
Genentech, Inc., Walther Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00317200
Brief Title
A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer
Official Title
Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer (SCLC): A Safety, Feasibility and Efficacy Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2011
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2007 (Actual)
Study Completion Date
November 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hoosier Cancer Research Network
Collaborators
Genentech, Inc., Walther Cancer Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Improvements in therapy for relapsed SCLC are much needed. Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC, including in refractory patients. Angiogenesis plays an important role in SCLC, increased VEGF levels are associated with worse outcomes. Bevacizumab, a monoclonal antibody to VEGF, increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC, breast cancer, and colorectal cancer. Paclitaxel plus bevacizumab, in the dose and schedule proposed in this study, improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer. Therefore, we will be testing the safety, feasibility, and efficacy of this regimen in patients with chemosensitive relapsed SCLC.
Detailed Description
OUTLINE: This is a multi-center study. Paclitaxel 90 mg/m2 IV infusion over 1 hour days 1, 8 and 15 of 28 day cycle Plus Bevacizumab 10 mg/kg on days 1 and 15 of 28 day cycle. 1 cycle = 28 days (4 weeks) Disease assessments will be performed per RECIST every other cycle After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy, bevacizumab monotherapy may continue until disease progression or intolerable side effects ECOG Performance Status 0 or 1 Hematopoietic: White blood cell count > 3,000 mm3 Absolute neutrophil count (ANC) > 1,500 mm3 Platelet count > 100,000 mm3 International normalized ration (INR) of prothrombin time ≤ 1.2 PTT no more than 5 seconds longer than the ULN Hepatic: Bilirubin < 1.5 x ULN Aspartate aminotransferase (AST, SGOT) < 2.5 x ULN Renal: Urine protein:creatinine ratio <1.0 Cardiovascular: No history of myocardial infarction or angina pectoris/anginal equivalent in the last 6 months. Note: The patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months. No history of uncontrolled congestive heart failure or uncontrolled hypertension

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
34 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Active Comparator
Arm Description
Paclitaxel + Devacizumab in patients with chemosensitive relapsed small cell lung cancer.
Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Description
Paclitaxel 90 mg/m2 IV infusion over 1 hour, days 1, 8 and 15 of 28 day cycle.
Intervention Type
Drug
Intervention Name(s)
Bevacizumab
Intervention Description
Bevacizumab 10 mg/kg, days 1 and 15 of 28 day cycle
Primary Outcome Measure Information:
Title
To determine progression free survival(PFS) of this regimen in patients with chemosensitive relapsed small cell lung cancer (SCLC).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
To determine the response rate of the combination of paclitaxel and bevacizumab with chemosensitive SCLC.
Time Frame
18 months
Title
To determine the toxicity of the combination of paclitaxel and bevacizumab in patients with SCLC.
Time Frame
18 months
Title
To determine overall survival.
Time Frame
18 months
Title
To assess VEGF polymorphisms in the study population.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Histologic or cytologic proof of small cell lung cancer Chemo-sensitive disease defined as relapsed after 60 days from completion of first line chemotherapy. Measurable disease according to RECIST and obtained by imaging within 28 days prior to being registered for protocol therapy. Must have received treatment with at least 1 but not more than 2 prior chemotherapy regimens. (At least one regimen must contain a platinum agent. Previous treatment with irinotecan is allowed.) Prior radiation therapy must be completed at least 21 days prior to being registered for protocol therapy, and toxicities due to radiation must have recovered to ≤ grade 1 or baseline prior to registration. Prior cancer treatment must be completed at least 21 days prior to being registered for protocol therapy and the subject must have recovered from the acute toxicity effects of the regimen prior to registration. Exclusion Criteria: No treatment with any investigational agent within 30 days prior to being registered for protocol therapy. No history or radiographic evidence of CNS involvement by head CT or MRI within 42 days prior to registration. No history of seizures, transient ischemic attack or stroke. No clinically significant infections as judged by the treating investigator. No other active cancer except SCLC. No prior treatment with topoisomerase I inhibitor. No contraindications to the use of paclitaxel or bevacizumab as per the investigator's clinical judgment. Must not have grade 3 or greater peripheral neuropathy. Must not have had major surgical procedure, open biopsy, or significant traumatic injury within 28 days of being registered for protocol therapy. No anticipation of need for major surgical procedure during the course of the study. Patients may not have had a minor surgical procedure, placement of an access device or fine needle aspiration within 7 days prior to being registered for protocol therapy. No evidence of bleeding diathesis or coagulopathy. No history of deep vein thrombosis or pulmonary embolism. No full dose/therapeutic anticoagulation with either low molecular weight heparin or unfractionated heparin or coumadin within 10 days prior to registration. Patients must not have been using aspirin (>325 mg/day) or another nonsteroidal anti-inflammatory medications known to inhibit platelet function on a daily basis within 10 days prior to registration on study. Patients must not be using any of the following drugs known to inhibit platelet function within 10 days prior to registration: dipyridamole (Persantine), ticlopidine (Ticlid), clopidogrel (Plavix) and cilostazol (Pletal). Patients must not have a current non-healing wound or fracture. Patients must not have a history of or current hemoptysis.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nasser Hanna, M.D.
Organizational Affiliation
Hoosier Oncology Group, LLC
Official's Role
Study Chair
Facility Information:
Facility Name
Highlands Oncology Group
City
Springdale
State/Province
Arkansas
ZIP/Postal Code
72764
Country
United States
Facility Name
Medical & Surgical Specialists, LLC
City
Galesburg
State/Province
Illinois
ZIP/Postal Code
61401
Country
United States
Facility Name
Cancer Care Center of Southern Indiana
City
Bloomington
State/Province
Indiana
ZIP/Postal Code
47403
Country
United States
Facility Name
Oncology Hematology Associates of SW Indiana
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Fort Wayne Oncology & Hematology, Inc
City
Fort Wayne
State/Province
Indiana
ZIP/Postal Code
46815
Country
United States
Facility Name
Center for Cancer Care at Goshen Health System
City
Goshen
State/Province
Indiana
ZIP/Postal Code
46527
Country
United States
Facility Name
Indiana University Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Quality Cancer Center (MCGOP)
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Community Regional Cancer Center
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46256
Country
United States
Facility Name
Arnett Cancer Care
City
Lafayette
State/Province
Indiana
ZIP/Postal Code
47904
Country
United States
Facility Name
Medical Consultants, P.C.
City
Muncie
State/Province
Indiana
ZIP/Postal Code
47303
Country
United States
Facility Name
Center for Cancer Care, Inc., P.C.
City
New Albany
State/Province
Indiana
ZIP/Postal Code
47150
Country
United States
Facility Name
Northern Indiana Cancer Research Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Siteman Cancer Center
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Methodist Cancer Center
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
Pennsylvania Oncology-Hematology Associates
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19106
Country
United States
Facility Name
Fox Chase Cancer Center Extramural Research Program
City
Rockledge
State/Province
Pennsylvania
ZIP/Postal Code
19046
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21102263
Citation
Jalal S, Bedano P, Einhorn L, Bhatia S, Ansari R, Bechar N, Koneru K, Govindan R, Wu J, Yu M, Schneider B, Hanna N. Paclitaxel plus bevacizumab in patients with chemosensitive relapsed small cell lung cancer: a safety, feasibility, and efficacy study from the Hoosier Oncology Group. J Thorac Oncol. 2010 Dec;5(12):2008-11. doi: 10.1097/JTO.0b013e3181f77b6e.
Results Reference
result
Links:
URL
http://www.hoosieroncologygroup.org
Description
Hoosier Oncology Group Home Page

Learn more about this trial

A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer

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