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S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

Primary Purpose

Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
docetaxel
vandetanib
Sponsored by
SWOG Cancer Research Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fallopian Tube Cancer focused on measuring recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cavity cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

  • Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma

    • Recurrent, refractory, or progressive/persistent disease
  • Measurable or non-measurable disease documented by CT scan of the abdomen and pelvis

  • Must have received 1 prior platinum-based chemotherapy regimen for management of primary disease containing carboplatin, cisplatin, or other organoplatinum compound

    • Initial treatment may have included any of the following:

      • High-dose therapy
      • Consolidation therapy
      • Non-cytotoxic agent therapy
      • Extended therapy administered after surgical or non-surgical assessment
    • Additional cytotoxic regimen for recurrent, refractory, or progressive/persistent disease, including re-treatment with primary treatment regimen
  • No more than 3 prior regimens for recurrent, refractory, persistent, or progressive disease.

PATIENT CHARACTERISTICS:

  • Zubrod performance status 0-2
  • Absolute neutrophil count (ANC) ≥ 1,500/mcl
  • Platelet count ≥ 100,000/mcl
  • Serum creatinine normal OR calculated creatinine clearance ≥ 30 mL/min
  • Urine protein:creatinine ratio < 1
  • Bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • aspartate aminotransferase - alanine aminotransferase (AST or ALT) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)
  • Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present)
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for ≥ 6 months after completion of vandetanib therapy
  • No neuropathy ≥ grade 2 CTCAE v4.0
  • No active infection requiring systemic or intravenous antibiotics
  • No significant traumatic injury within the past 28 days

  • No significant cardiovascular disease, including any of the following:

    • Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 140 mm Hg or diastolic BP > 90 mm Hg) within the past 28 days
    • Myocardial infarction superior vena cava syndrome, or New York Heart Association (NYHA) class II-IV heart disease within the past 3 months
    • Presence of left bundle branch block
    • Congenital long QT syndrome or first degree relative with unexplained sudden death < 40 years of age
    • QT interval with Bazett's correction that is unmeasurable or ≥ 480 msec by screening ECG

    • History of symptomatic arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) requiring treatment (≥ CTCAE grade 3) or asymptomatic sustained ventricular tachycardia

      • Atrial fibrillation controlled on medication allowed

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • Recovered from all prior therapy (except alopecia) to NCI CTCAE v3.0 grade ≤ 1

  • No prior vandetanib

    • Treatment with other anti-vascular endothelial growth factor (VEGF) targeted therapy allowed

  • No prior docetaxel or any non-cytotoxic therapy (excluding hormonal therapy) for recurrent disease, regardless of whether it was part of primary treatment

    • Prior docetaxel as part of front-line cytotoxic regimen (including maintenance therapy) allowed as long as no disease progression on or within 6 months after receiving docetaxel

  • At least 7 days since prior hormonal therapy for the malignant tumor

    • Concurrent hormone replacement therapy for menopausal symptoms allowed
  • At least 28 days since other prior therapy for the malignant tumor, including immunologic agents
  • More than 7 days since prior minor surgical procedures, fine needle aspirates, or core biopsies
  • More than 14 days since prior and no concurrent potent inducers of cytochrome P450 3A4 (CYP3A4) function

  • More than 14 days since prior and no concurrent medications having a risk of causing Torsades de Pointes or risk of QTc prolongation

    • Patients receiving a drug that has a risk of QTc prolongation must not have QTc ≥ 460 msec
  • More than 28 days since prior investigational agents for any purpose
  • More than 28 days since prior and no concurrent major surgical procedure or open biopsy

  • More than 5 years since prior chemotherapy for abdominal or pelvic tumor, except treatment of ovarian, fallopian tube, or primary peritoneal cancer

    • Prior adjuvant chemotherapy for localized breast cancer allowed, provided it was completed more than 3 years prior to study, and the patient remains free of recurrent or metastatic disease

  • More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian, fallopian tube, or primary peritoneal cancer

    • Prior radiotherapy for localized cancer of the breast, head and neck, or skin allowed, provided it was completed more than 3 years prior to study, and the patient remains free of recurrent or metastatic disease

    • No prior radiation to more than 25% of marrow-bearing areas

      • More than 28 days since prior radiotherapy
  • No other concurrent investigational or commercial agents

Sites / Locations

  • Providence Cancer Center at Providence Hospital
  • Alaska Regional Hospital Cancer Center
  • Arizona Cancer Center at University of Arizona Health Sciences Center
  • NEA Medical Center - Stadium Boulevard
  • Alta Bates Summit Comprehensive Cancer Center
  • Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
  • Peninsula Medical Center
  • USC/Norris Comprehensive Cancer Center and Hospital
  • Contra Costa Regional Medical Center
  • Tibotec Therapeutics - Division of Ortho Biotech Products, LP
  • El Camino Hospital Cancer Center
  • Highland General Hospital
  • Alta Bates Summit Medical Center - Summit Campus
  • CCOP - Bay Area Tumor Institute
  • Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
  • University of California Davis Cancer Center
  • California Pacific Medical Center - California Campus
  • Doctors Medical Center - San Pablo Campus
  • Sutter Health - Western Division Cancer Research Group
  • Tahoe Forest Cancer Center
  • Sutter Solano Medical Center
  • San Luis Valley Regional Medical Center
  • University of Colorado Cancer Center at UC Health Sciences Center
  • Shaw Regional Cancer Center
  • Valley View Hospital Cancer Center
  • St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
  • Montrose Memorial Hospital Cancer Center
  • Kapiolani Medical Center at Pali Momi
  • Cancer Research Center of Hawaii
  • OnCare Hawaii, Incorporated - Lusitana
  • Queen's Cancer Institute at Queen's Medical Center
  • Straub Clinic and Hospital, Incorporated
  • Hawaii Medical Center - East
  • OnCare Hawaii, Incorporated - Kuakini
  • Kapiolani Medical Center for Women and Children
  • Castle Medical Center
  • Kauai Medical Clinic
  • Maui Memorial Medical Center
  • Saint Anthony's Hospital at Saint Anthony's Health Center
  • University of Chicago Cancer Research Center
  • Good Samaritan Regional Health Center
  • Central Dupage Cancer Center
  • St. Francis Hospital and Health Centers - Beech Grove Campus
  • Reid Hospital & Health Care Services
  • Cancer Center of Kansas, PA - Chanute
  • Cancer Center of Kansas, PA - Dodge City
  • Cancer Center of Kansas, PA - El Dorado
  • Cancer Center of Kansas - Fort Scott
  • Cancer Center of Kansas-Independence
  • Cancer Center of Kansas, PA - Kingman
  • Lawrence Memorial Hospital
  • Cancer Center of Kansas, PA - Liberal
  • Cancer Center of Kansas, PA - Newton
  • Cancer Center of Kansas, PA - Parsons
  • Cancer Center of Kansas, PA - Pratt
  • Cancer Center of Kansas, PA - Salina
  • Tammy Walker Cancer Center at Salina Regional Health Center
  • Cancer Center of Kansas, PA - Wellington
  • Associates in Womens Health, PA - North Review
  • Cancer Center of Kansas, PA - Medical Arts Tower
  • Cancer Center of Kansas, PA - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas, PA - Winfield
  • Tulane Cancer Center Office of Clinical Research
  • Greenebaum Cancer Center at University of Maryland Medical Center
  • Caritas Holy Family Hospital
  • Battle Creek Health System Cancer Care Center
  • Mecosta County Medical Center
  • Josephine Ford Cancer Center at Henry Ford Hospital
  • Butterworth Hospital at Spectrum Health
  • CCOP - Grand Rapids
  • Lacks Cancer Center at Saint Mary's Health Care
  • Mercy General Health Partners
  • Munson Medical Center
  • Regional Cancer Center at Singing River Hospital
  • Saint Francis Medical Center
  • Midwest Hematology Oncology Group, Incorporated
  • CCOP - St. Louis-Cape Girardeau
  • David C. Pratt Cancer Center at St. John's Mercy
  • CCOP - Cancer Research for the Ozarks
  • St. John's Regional Health Center
  • Hulston Cancer Center at Cox Medical Center South
  • CCOP - Montana Cancer Consortium
  • St. Vincent Healthcare Cancer Care Services
  • Hematology-Oncology Centers of the Northern Rockies - Billings
  • Billings Clinic - Downtown
  • Bozeman Deaconess Cancer Center
  • Big Sky Oncology
  • Great Falls Clinic - Main Facility
  • Sletten Cancer Institute at Benefis Healthcare
  • St. Peter's Hospital
  • Glacier Oncology, PLLC
  • Kalispell Regional Medical Center
  • Montana Cancer Specialists at Montana Cancer Center
  • Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
  • University Medical Center of Southern Nevada
  • CCOP - Nevada Cancer Research Foundation
  • Falck Cancer Center at Arnot Ogden Medical Center
  • Tucker Center for Cancer Care at Orange Regional Medical Center
  • Highland Hospital of Rochester
  • Wayne Memorial Hospital, Incorporated
  • Pardee Memorial Hospital
  • Grandview Hospital
  • Good Samaritan Hospital
  • David L. Rike Cancer Center at Miami Valley Hospital
  • Samaritan North Cancer Care Center
  • CCOP - Dayton
  • Blanchard Valley Medical Associates
  • Middletown Regional Hospital
  • Wayne Hospital
  • Charles F. Kettering Memorial Hospital
  • UVMC Cancer Care Center at Upper Valley Medical Center
  • Clinton Memorial Hospital
  • United States Air Force Medical Center - Wright-Patterson
  • Ruth G. McMillan Cancer Center at Greene Memorial Hospital
  • Fox Chase Cancer Center - Philadelphia
  • U.T. Medical Center Cancer Institute
  • M. D. Anderson Cancer Center at University of Texas
  • Danville Regional Medical Center
  • St. Joseph Cancer Center
  • Olympic Hematology and Oncology
  • Columbia Basin Hematology
  • Skagit Valley Hospital Cancer Care Center
  • Harrison Poulsbo Hematology and Onocology
  • Harborview Medical Center
  • Minor and James Medical, PLLC
  • Fred Hutchinson Cancer Research Center
  • Group Health Central Hospital
  • Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
  • Polyclinic First Hill
  • University Cancer Center at University of Washington Medical Center
  • Cancer Care Northwest - Spokane South
  • Evergreen Hematology and Oncology, PS
  • Wenatchee Valley Medical Center
  • Rocky Mountain Oncology
  • Welch Cancer Center at Sheridan Memorial Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm I

Arm II

Arm Description

Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.

Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS)
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.

Secondary Outcome Measures

Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by 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 in conjunction with measured CA125 responses
Overall Survival
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Number of Patients With Gr 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.
Time to Treatment Failure
Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.
Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by 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 in conjunction with measured CA125 responses

Full Information

First Posted
March 31, 2009
Last Updated
October 26, 2016
Sponsor
SWOG Cancer Research Network
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00872989
Brief Title
S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
Official Title
Randomized Phase II Study of Docetaxel Followed by Vandetanib (ZD6474) vs. Docetaxel Plus Vandetanib in Patients With Persistent or Recurrent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
March 2010 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Vandetanib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor. It is not yet known whether docetaxel is more effective when given alone or together with vandetanib. PURPOSE: This randomized phase II trial is studying docetaxel given together with or without vandetanib to see how well it works in treating patients with persistent or recurrent ovarian epithelial cancer, fallopian tube cancer, or primary peritoneal cancer.
Detailed Description
OBJECTIVES: To evaluate the clinical efficacy of docetaxel and vandetanib relative to docetaxel alone in patients with platinum-resistant, recurrent, refractory, or progressive/persistent ovarian epithelial, primary peritoneal, or fallopian tube cancer, as measured by progression-free survival. To evaluate the response rate (complete and partial) and duration of overall survival of these patients. To evaluate the response (complete and partial) and time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. To evaluate the frequency and severity of adverse events as assessed by Common Toxicity Criteria for Adverse Effects (CTCAE) v4.0. To evaluate the toxicity of single agent vandetanib following docetaxel as assessed by CTCAE v4.0. OUTLINE: Patients are stratified according to prior treatment with antiangiogenesis agents (yes vs no). Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity. Arm II: Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed every 3 months for 2 years and then every 6 months for 3 years.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fallopian Tube Cancer, Ovarian Cancer, Primary Peritoneal Cavity Cancer
Keywords
recurrent ovarian epithelial cancer, recurrent fallopian tube cancer, recurrent primary peritoneal cavity cancer

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Arm I
Arm Type
Experimental
Arm Description
Patients receive docetaxel IV over 1 hour on day 1. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. Patients who progress also receive oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of a second disease progression or unacceptable toxicity.
Arm Title
Arm II
Arm Type
Experimental
Arm Description
Patients receive docetaxel IV over 1 hour on day 1 and oral vandetanib once daily on days 1-21. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Description
Given IV
Intervention Type
Drug
Intervention Name(s)
vandetanib
Intervention Description
Given orally
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS)
Description
From date of registration to date of first documentation of progression or symptomatic deterioration, or death due to any cause. Patients last known to be alive and progression free are censored at date of last contact.
Time Frame
Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years
Secondary Outcome Measure Information:
Title
Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by 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 in conjunction with measured CA125 responses
Time Frame
Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years.
Title
Overall Survival
Description
From date of registration to date of death due to any cause. Patients last known to be alive are censored at date of last contact.
Time Frame
every 3 months for two years and then every 6 months for 3 years
Title
Number of Patients With Gr 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.
Time Frame
Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years.
Title
Time to Treatment Failure
Description
Time to treatment failure after treatment with single agent vandetanib following progression on single agent docetaxel. Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.
Time Frame
Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.
Title
Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease After Treatment With Single Agent Vandetanib Following Progression on Single Agent Docetaxel
Description
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by 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 in conjunction with measured CA125 responses
Time Frame
Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed ovarian epithelial, fallopian tube, or primary peritoneal carcinoma Recurrent, refractory, or progressive/persistent disease Measurable or non-measurable disease documented by CT scan of the abdomen and pelvis Must have received 1 prior platinum-based chemotherapy regimen for management of primary disease containing carboplatin, cisplatin, or other organoplatinum compound Initial treatment may have included any of the following: High-dose therapy Consolidation therapy Non-cytotoxic agent therapy Extended therapy administered after surgical or non-surgical assessment Additional cytotoxic regimen for recurrent, refractory, or progressive/persistent disease, including re-treatment with primary treatment regimen No more than 3 prior regimens for recurrent, refractory, persistent, or progressive disease. PATIENT CHARACTERISTICS: Zubrod performance status 0-2 Absolute neutrophil count (ANC) ≥ 1,500/mcl Platelet count ≥ 100,000/mcl Serum creatinine normal OR calculated creatinine clearance ≥ 30 mL/min Urine protein:creatinine ratio < 1 Bilirubin ≤ 1.5 times upper limit of normal (ULN) aspartate aminotransferase - alanine aminotransferase (AST or ALT) ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present) Alkaline phosphatase ≤ 2.5 times ULN (≤ 5 times ULN if liver metastases are present) Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for ≥ 6 months after completion of vandetanib therapy No neuropathy ≥ grade 2 CTCAE v4.0 No active infection requiring systemic or intravenous antibiotics No significant traumatic injury within the past 28 days No significant cardiovascular disease, including any of the following: Uncontrolled hypertension (i.e., systolic blood pressure [BP] > 140 mm Hg or diastolic BP > 90 mm Hg) within the past 28 days Myocardial infarction superior vena cava syndrome, or New York Heart Association (NYHA) class II-IV heart disease within the past 3 months Presence of left bundle branch block Congenital long QT syndrome or first degree relative with unexplained sudden death < 40 years of age QT interval with Bazett's correction that is unmeasurable or ≥ 480 msec by screening ECG History of symptomatic arrhythmia (i.e., multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation) requiring treatment (≥ CTCAE grade 3) or asymptomatic sustained ventricular tachycardia Atrial fibrillation controlled on medication allowed PRIOR CONCURRENT THERAPY: See Disease Characteristics Recovered from all prior therapy (except alopecia) to NCI CTCAE v3.0 grade ≤ 1 No prior vandetanib Treatment with other anti-vascular endothelial growth factor (VEGF) targeted therapy allowed No prior docetaxel or any non-cytotoxic therapy (excluding hormonal therapy) for recurrent disease, regardless of whether it was part of primary treatment Prior docetaxel as part of front-line cytotoxic regimen (including maintenance therapy) allowed as long as no disease progression on or within 6 months after receiving docetaxel At least 7 days since prior hormonal therapy for the malignant tumor Concurrent hormone replacement therapy for menopausal symptoms allowed At least 28 days since other prior therapy for the malignant tumor, including immunologic agents More than 7 days since prior minor surgical procedures, fine needle aspirates, or core biopsies More than 14 days since prior and no concurrent potent inducers of cytochrome P450 3A4 (CYP3A4) function More than 14 days since prior and no concurrent medications having a risk of causing Torsades de Pointes or risk of QTc prolongation Patients receiving a drug that has a risk of QTc prolongation must not have QTc ≥ 460 msec More than 28 days since prior investigational agents for any purpose More than 28 days since prior and no concurrent major surgical procedure or open biopsy More than 5 years since prior chemotherapy for abdominal or pelvic tumor, except treatment of ovarian, fallopian tube, or primary peritoneal cancer Prior adjuvant chemotherapy for localized breast cancer allowed, provided it was completed more than 3 years prior to study, and the patient remains free of recurrent or metastatic disease More than 5 years since prior radiotherapy to any portion of the abdominal cavity or pelvis, except for the treatment of ovarian, fallopian tube, or primary peritoneal cancer Prior radiotherapy for localized cancer of the breast, head and neck, or skin allowed, provided it was completed more than 3 years prior to study, and the patient remains free of recurrent or metastatic disease No prior radiation to more than 25% of marrow-bearing areas More than 28 days since prior radiotherapy No other concurrent investigational or commercial agents
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert L. Coleman, MD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Providence Cancer Center at Providence Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
Alaska Regional Hospital Cancer Center
City
Anchorage
State/Province
Alaska
ZIP/Postal Code
99508
Country
United States
Facility Name
Arizona Cancer Center at University of Arizona Health Sciences Center
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724-5024
Country
United States
Facility Name
NEA Medical Center - Stadium Boulevard
City
Jonesboro
State/Province
Arkansas
ZIP/Postal Code
72401
Country
United States
Facility Name
Alta Bates Summit Comprehensive Cancer Center
City
Berkeley
State/Province
California
ZIP/Postal Code
94704
Country
United States
Facility Name
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Peninsula Medical Center
City
Burlingame
State/Province
California
ZIP/Postal Code
94010
Country
United States
Facility Name
USC/Norris Comprehensive Cancer Center and Hospital
City
Los Angeles
State/Province
California
ZIP/Postal Code
90089-9181
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
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
City
Marysville
State/Province
California
ZIP/Postal Code
95901
Country
United States
Facility Name
El Camino Hospital Cancer Center
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
CCOP - Bay Area Tumor Institute
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
University of California Davis Cancer Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
California Pacific Medical Center - California Campus
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States
Facility Name
Doctors Medical Center - San Pablo Campus
City
San Pablo
State/Province
California
ZIP/Postal Code
94806
Country
United States
Facility Name
Sutter Health - Western Division Cancer Research Group
City
San Rafael
State/Province
California
ZIP/Postal Code
94903
Country
United States
Facility Name
Tahoe Forest Cancer Center
City
Truckee
State/Province
California
ZIP/Postal Code
96161
Country
United States
Facility Name
Sutter Solano Medical Center
City
Vallejo
State/Province
California
ZIP/Postal Code
94589
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 at UC Health Sciences Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
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
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
City
Grand Junction
State/Province
Colorado
ZIP/Postal Code
81502
Country
United States
Facility Name
Montrose Memorial Hospital Cancer Center
City
Montrose
State/Province
Colorado
ZIP/Postal Code
81401
Country
United States
Facility Name
Kapiolani Medical Center at Pali Momi
City
Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
Cancer Research Center of Hawaii
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Lusitana
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Queen's Cancer Institute at Queen's Medical Center
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Straub Clinic and Hospital, Incorporated
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96813
Country
United States
Facility Name
Hawaii Medical Center - East
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
OnCare Hawaii, Incorporated - Kuakini
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96817
Country
United States
Facility Name
Kapiolani Medical Center for Women and Children
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96826
Country
United States
Facility Name
Castle Medical Center
City
Kailua
State/Province
Hawaii
ZIP/Postal Code
96734
Country
United States
Facility Name
Kauai Medical Clinic
City
Lihue
State/Province
Hawaii
ZIP/Postal Code
96766
Country
United States
Facility Name
Maui Memorial Medical Center
City
Wailuku
State/Province
Hawaii
ZIP/Postal Code
96793
Country
United States
Facility Name
Saint Anthony's Hospital at Saint Anthony's Health Center
City
Alton
State/Province
Illinois
ZIP/Postal Code
62002
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
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
Central Dupage Cancer Center
City
Warrenville
State/Province
Illinois
ZIP/Postal Code
60555
Country
United States
Facility Name
St. Francis Hospital and Health Centers - Beech Grove Campus
City
Beech Grove
State/Province
Indiana
ZIP/Postal Code
46107
Country
United States
Facility Name
Reid Hospital & Health Care Services
City
Richmond
State/Province
Indiana
ZIP/Postal Code
47374
Country
United States
Facility Name
Cancer Center of Kansas, PA - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas, PA - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, PA - 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
Cancer Center of Kansas-Independence
City
Independence
State/Province
Kansas
ZIP/Postal Code
67301
Country
United States
Facility Name
Cancer Center of Kansas, PA - 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, PA - Liberal
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67905
Country
United States
Facility Name
Cancer Center of Kansas, PA - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas, PA - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Cancer Center of Kansas, PA - Pratt
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas, PA - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Tammy Walker Cancer Center at Salina Regional Health Center
City
Salina
State/Province
Kansas
ZIP/Postal Code
67401
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health, PA - North Review
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Medical Arts Tower
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, PA - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas, PA - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Tulane Cancer Center Office of Clinical Research
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71315-3198
Country
United States
Facility Name
Greenebaum Cancer Center at University of Maryland Medical Center
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Caritas Holy Family Hospital
City
Methuen
State/Province
Massachusetts
ZIP/Postal Code
01844
Country
United States
Facility Name
Battle Creek Health System Cancer Care Center
City
Battle Creek
State/Province
Michigan
ZIP/Postal Code
49017
Country
United States
Facility Name
Mecosta County Medical Center
City
Big Rapids
State/Province
Michigan
ZIP/Postal Code
49307
Country
United States
Facility Name
Josephine Ford Cancer Center at Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
Facility Name
Butterworth Hospital at Spectrum Health
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
CCOP - Grand Rapids
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Lacks Cancer Center at Saint Mary's Health Care
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Mercy General Health Partners
City
Muskegon
State/Province
Michigan
ZIP/Postal Code
49443
Country
United States
Facility Name
Munson Medical Center
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Regional Cancer Center at 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
Midwest Hematology Oncology Group, Incorporated
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63109
Country
United States
Facility Name
CCOP - St. Louis-Cape Girardeau
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
David C. Pratt Cancer Center at St. John's Mercy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Facility Name
CCOP - Cancer Research for the Ozarks
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65802
Country
United States
Facility Name
St. John's Regional Health Center
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65804
Country
United States
Facility Name
Hulston Cancer Center at Cox Medical Center South
City
Springfield
State/Province
Missouri
ZIP/Postal Code
65807
Country
United States
Facility Name
CCOP - Montana Cancer Consortium
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
St. Vincent Healthcare Cancer Care Services
City
Billings
State/Province
Montana
ZIP/Postal Code
59101
Country
United States
Facility Name
Hematology-Oncology Centers of the Northern Rockies - Billings
City
Billings
State/Province
Montana
ZIP/Postal Code
59102
Country
United States
Facility Name
Billings Clinic - Downtown
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
Big Sky Oncology
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405-5309
Country
United States
Facility Name
Great Falls Clinic - Main Facility
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
Sletten Cancer Institute at Benefis Healthcare
City
Great Falls
State/Province
Montana
ZIP/Postal Code
59405
Country
United States
Facility Name
St. Peter's 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 Regional Medical Center
City
Kalispell
State/Province
Montana
ZIP/Postal Code
59901
Country
United States
Facility Name
Montana Cancer Specialists at Montana Cancer Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807-7877
Country
United States
Facility Name
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
City
Missoula
State/Province
Montana
ZIP/Postal Code
59807
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
CCOP - Nevada Cancer Research Foundation
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Falck Cancer Center at Arnot Ogden Medical Center
City
Elmira
State/Province
New York
ZIP/Postal Code
14905
Country
United States
Facility Name
Tucker Center for Cancer Care at Orange Regional Medical Center
City
Middletown
State/Province
New York
ZIP/Postal Code
10940-4199
Country
United States
Facility Name
Highland Hospital of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Wayne Memorial Hospital, Incorporated
City
Goldsboro
State/Province
North Carolina
ZIP/Postal Code
27534
Country
United States
Facility Name
Pardee Memorial Hospital
City
Hendersonville
State/Province
North Carolina
ZIP/Postal Code
28791
Country
United States
Facility Name
Grandview Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45405
Country
United States
Facility Name
Good Samaritan Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45406
Country
United States
Facility Name
David L. Rike Cancer Center at Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Samaritan North Cancer Care Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
CCOP - Dayton
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45420
Country
United States
Facility Name
Blanchard Valley Medical Associates
City
Findlay
State/Province
Ohio
ZIP/Postal Code
45840
Country
United States
Facility Name
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
Charles F. Kettering Memorial Hospital
City
Kettering
State/Province
Ohio
ZIP/Postal Code
45429
Country
United States
Facility Name
UVMC Cancer Care Center at Upper Valley Medical Center
City
Troy
State/Province
Ohio
ZIP/Postal Code
45373-1300
Country
United States
Facility Name
Clinton Memorial Hospital
City
Wilmington
State/Province
Ohio
ZIP/Postal Code
45177
Country
United States
Facility Name
United States Air Force Medical Center - Wright-Patterson
City
Wright-Patterson Afb
State/Province
Ohio
ZIP/Postal Code
45433-5529
Country
United States
Facility Name
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Fox Chase Cancer Center - Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
U.T. Medical Center Cancer Institute
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920-6999
Country
United States
Facility Name
M. D. Anderson Cancer Center at University of Texas
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
Danville Regional Medical Center
City
Danville
State/Province
Virginia
ZIP/Postal Code
24541
Country
United States
Facility Name
St. Joseph Cancer Center
City
Bellingham
State/Province
Washington
ZIP/Postal Code
98225
Country
United States
Facility Name
Olympic Hematology and Oncology
City
Bremerton
State/Province
Washington
ZIP/Postal Code
98310
Country
United States
Facility Name
Columbia Basin Hematology
City
Kennewick
State/Province
Washington
ZIP/Postal Code
99336
Country
United States
Facility Name
Skagit Valley Hospital Cancer Care Center
City
Mt. Vernon
State/Province
Washington
ZIP/Postal Code
98273
Country
United States
Facility Name
Harrison Poulsbo Hematology and Onocology
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
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
Group Health Central Hospital
City
Seattle
State/Province
Washington
ZIP/Postal Code
98112
Country
United States
Facility Name
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122-4307
Country
United States
Facility Name
Polyclinic First Hill
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University Cancer Center at University of Washington Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
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
Wenatchee Valley Medical Center
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801-2028
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 at Sheridan Memorial Hospital
City
Sheridan
State/Province
Wyoming
ZIP/Postal Code
82801
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
24709487
Citation
Coleman RL, Moon J, Sood AK, Hu W, Delmore JE, Bonebrake AJ, Anderson GL, Chambers SK, Markman M. Randomised phase II study of docetaxel plus vandetanib versus docetaxel followed by vandetanib in patients with persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal carcinoma: SWOG S0904. Eur J Cancer. 2014 Jun;50(9):1638-48. doi: 10.1016/j.ejca.2014.03.005. Epub 2014 Apr 4.
Results Reference
result

Learn more about this trial

S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer

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