S0904: Docetaxel With or Without Vandetanib in Treating Patients With Persistent or Recurrent Ovarian Epithelial Cancer, Fallopian Tube Cancer, or Primary Peritoneal Cancer
- Conditions
- Fallopian Tube CancerOvarian CancerPrimary Peritoneal Cavity Cancer
- Interventions
- Registration Number
- NCT00872989
- Lead Sponsor
- SWOG Cancer Research Network
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 129
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Arm I docetaxel 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 vandetanib 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. Arm II docetaxel 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. Arm I vandetanib 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.
- Primary Outcome Measures
Name Time Method Progression Free Survival (PFS) Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years 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
Name Time Method Number of Participants With a Complete Response, Partial Response, Stable Disease, or Increasing Disease Disease assessment for responses were performed every 6 weeks for as long as the patient remained on protocol treatment, up to 5 years. 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 every 3 months for two years and then every 6 months for 3 years 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 Toxicity assessment was evaluated before each treatment cycle (21 days), up to 5 years. 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 Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years. 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 Disease assessments were performed every 6 weeks for as long as the patient remained on protocol, up to 5 years. 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
Trial Locations
- Locations (137)
Sletten Cancer Institute at Benefis Healthcare
🇺🇸Great Falls, Montana, United States
Montana Cancer Specialists at Montana Cancer Center
🇺🇸Missoula, Montana, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
🇺🇸Missoula, Montana, United States
University of Chicago Cancer Research Center
🇺🇸Chicago, Illinois, United States
Cancer Center of Kansas, PA - Dodge City
🇺🇸Dodge City, Kansas, United States
Cancer Center of Kansas, PA - Wichita
🇺🇸Wichita, Kansas, United States
Welch Cancer Center at Sheridan Memorial Hospital
🇺🇸Sheridan, Wyoming, United States
Rocky Mountain Oncology
🇺🇸Casper, Wyoming, United States
Straub Clinic and Hospital, Incorporated
🇺🇸Honolulu, Hawaii, United States
Valley View Hospital Cancer Center
🇺🇸Glenwood Springs, Colorado, United States
Montrose Memorial Hospital Cancer Center
🇺🇸Montrose, Colorado, United States
Kapiolani Medical Center at Pali Momi
🇺🇸Aiea, Hawaii, United States
OnCare Hawaii, Incorporated - Lusitana
🇺🇸Honolulu, Hawaii, United States
Cancer Center of Kansas-Independence
🇺🇸Independence, Kansas, United States
Lawrence Memorial Hospital
🇺🇸Lawrence, Kansas, United States
Cancer Center of Kansas, PA - Newton
🇺🇸Newton, Kansas, United States
Cancer Center of Kansas, PA - Parsons
🇺🇸Parsons, Kansas, United States
Cancer Center of Kansas, PA - Winfield
🇺🇸Winfield, Kansas, United States
Cancer Center of Kansas, PA - Kingman
🇺🇸Kingman, Kansas, United States
Associates in Womens Health, PA - North Review
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Liberal
🇺🇸Liberal, Kansas, United States
Maui Memorial Medical Center
🇺🇸Wailuku, Hawaii, United States
Tammy Walker Cancer Center at Salina Regional Health Center
🇺🇸Salina, Kansas, United States
Cancer Research Center of Hawaii
🇺🇸Honolulu, Hawaii, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
🇺🇸Wichita, Kansas, United States
Greenebaum Cancer Center at University of Maryland Medical Center
🇺🇸Baltimore, Maryland, United States
Cancer Center of Kansas, PA - Chanute
🇺🇸Chanute, Kansas, United States
Cancer Center of Kansas, PA - Wellington
🇺🇸Wellington, Kansas, United States
Munson Medical Center
🇺🇸Traverse City, Michigan, United States
Tulane Cancer Center Office of Clinical Research
🇺🇸Alexandria, Louisiana, United States
Caritas Holy Family Hospital
🇺🇸Methuen, Massachusetts, United States
Regional Cancer Center at Singing River Hospital
🇺🇸Pascagoula, Mississippi, United States
Billings Clinic - Downtown
🇺🇸Billings, Montana, United States
Glacier Oncology, PLLC
🇺🇸Kalispell, Montana, United States
CCOP - Wichita
🇺🇸Wichita, Kansas, United States
Mecosta County Medical Center
🇺🇸Big Rapids, Michigan, United States
Cancer Center of Kansas - Fort Scott
🇺🇸Fort Scott, Kansas, United States
CCOP - Cancer Research for the Ozarks
🇺🇸Springfield, Missouri, United States
Battle Creek Health System Cancer Care Center
🇺🇸Battle Creek, Michigan, United States
University Medical Center of Southern Nevada
🇺🇸Las Vegas, Nevada, United States
Pardee Memorial Hospital
🇺🇸Hendersonville, North Carolina, United States
Bozeman Deaconess Cancer Center
🇺🇸Bozeman, Montana, United States
CCOP - Nevada Cancer Research Foundation
🇺🇸Las Vegas, Nevada, United States
Good Samaritan Hospital
🇺🇸Dayton, Ohio, United States
CCOP - Montana Cancer Consortium
🇺🇸Billings, Montana, United States
Tucker Center for Cancer Care at Orange Regional Medical Center
🇺🇸Middletown, New York, United States
Great Falls Clinic - Main Facility
🇺🇸Great Falls, Montana, United States
Kalispell Regional Medical Center
🇺🇸Kalispell, Montana, United States
St. John's Regional Health Center
🇺🇸Springfield, Missouri, United States
Queen's Cancer Institute at Queen's Medical Center
🇺🇸Honolulu, Hawaii, United States
Hawaii Medical Center - East
🇺🇸Honolulu, Hawaii, United States
OnCare Hawaii, Incorporated - Kuakini
🇺🇸Honolulu, Hawaii, United States
Lacks Cancer Center at Saint Mary's Health Care
🇺🇸Grand Rapids, Michigan, United States
Central Dupage Cancer Center
🇺🇸Warrenville, Illinois, United States
Sutter Solano Medical Center
🇺🇸Vallejo, California, United States
Charles F. Kettering Memorial Hospital
🇺🇸Kettering, Ohio, United States
Providence Cancer Center at Providence Hospital
🇺🇸Mobile, Alabama, United States
Arizona Cancer Center at University of Arizona Health Sciences Center
🇺🇸Tucson, Arizona, United States
Alaska Regional Hospital Cancer Center
🇺🇸Anchorage, Alaska, United States
NEA Medical Center - Stadium Boulevard
🇺🇸Jonesboro, Arkansas, United States
USC/Norris Comprehensive Cancer Center and Hospital
🇺🇸Los Angeles, California, United States
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center
🇺🇸Burbank, California, United States
Alta Bates Summit Comprehensive Cancer Center
🇺🇸Berkeley, California, United States
Tibotec Therapeutics - Division of Ortho Biotech Products, LP
🇺🇸Marysville, California, United States
Contra Costa Regional Medical Center
🇺🇸Martinez, California, United States
Peninsula Medical Center
🇺🇸Burlingame, California, United States
Highland General Hospital
🇺🇸Oakland, California, United States
CCOP - Bay Area Tumor Institute
🇺🇸Oakland, California, United States
University of California Davis Cancer Center
🇺🇸Sacramento, California, United States
Doctors Medical Center - San Pablo Campus
🇺🇸San Pablo, California, United States
Tahoe Forest Cancer Center
🇺🇸Truckee, California, United States
Sutter Health - Western Division Cancer Research Group
🇺🇸San Rafael, California, United States
San Luis Valley Regional Medical Center
🇺🇸Alamosa, Colorado, United States
Shaw Regional Cancer Center
🇺🇸Edwards, Colorado, United States
University of Colorado Cancer Center at UC Health Sciences Center
🇺🇸Aurora, Colorado, United States
Castle Medical Center
🇺🇸Kailua, Hawaii, United States
St. Francis Hospital and Health Centers - Beech Grove Campus
🇺🇸Beech Grove, Indiana, United States
Reid Hospital & Health Care Services
🇺🇸Richmond, Indiana, United States
Cancer Center of Kansas, PA - El Dorado
🇺🇸El Dorado, Kansas, United States
Cancer Center of Kansas, PA - Salina
🇺🇸Salina, Kansas, United States
Josephine Ford Cancer Center at Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
Butterworth Hospital at Spectrum Health
🇺🇸Grand Rapids, Michigan, United States
Mercy General Health Partners
🇺🇸Muskegon, Michigan, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
🇺🇸Billings, Montana, United States
Hulston Cancer Center at Cox Medical Center South
🇺🇸Springfield, Missouri, United States
Big Sky Oncology
🇺🇸Great Falls, Montana, United States
St. Vincent Healthcare Cancer Care Services
🇺🇸Billings, Montana, United States
St. Peter's Hospital
🇺🇸Helena, Montana, United States
Falck Cancer Center at Arnot Ogden Medical Center
🇺🇸Elmira, New York, United States
Wayne Memorial Hospital, Incorporated
🇺🇸Goldsboro, North Carolina, United States
Grandview Hospital
🇺🇸Dayton, Ohio, United States
CCOP - Dayton
🇺🇸Dayton, Ohio, United States
David L. Rike Cancer Center at Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
Samaritan North Cancer Care Center
🇺🇸Dayton, Ohio, United States
Blanchard Valley Medical Associates
🇺🇸Findlay, Ohio, United States
Clinton Memorial Hospital
🇺🇸Wilmington, Ohio, United States
Wayne Hospital
🇺🇸Greenville, Ohio, United States
UVMC Cancer Care Center at Upper Valley Medical Center
🇺🇸Troy, Ohio, United States
Fox Chase Cancer Center - Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
M. D. Anderson Cancer Center at University of Texas
🇺🇸Houston, Texas, United States
U.T. Medical Center Cancer Institute
🇺🇸Knoxville, Tennessee, United States
St. Joseph Cancer Center
🇺🇸Bellingham, Washington, United States
Olympic Hematology and Oncology
🇺🇸Bremerton, Washington, United States
Danville Regional Medical Center
🇺🇸Danville, Virginia, United States
Minor and James Medical, PLLC
🇺🇸Seattle, Washington, United States
Columbia Basin Hematology
🇺🇸Kennewick, Washington, United States
Skagit Valley Hospital Cancer Care Center
🇺🇸Mt. Vernon, Washington, United States
Harrison Poulsbo Hematology and Onocology
🇺🇸Poulsbo, Washington, United States
Harborview Medical Center
🇺🇸Seattle, Washington, United States
Fred Hutchinson Cancer Research Center
🇺🇸Seattle, Washington, United States
Group Health Central Hospital
🇺🇸Seattle, Washington, United States
Polyclinic First Hill
🇺🇸Seattle, Washington, United States
University Cancer Center at University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Cancer Care Northwest - Spokane South
🇺🇸Spokane, Washington, United States
Wenatchee Valley Medical Center
🇺🇸Wenatchee, Washington, United States
Kapiolani Medical Center for Women and Children
🇺🇸Honolulu, Hawaii, United States
El Camino Hospital Cancer Center
🇺🇸Mountain View, California, United States
Alta Bates Summit Medical Center - Summit Campus
🇺🇸Oakland, California, United States
Saint Francis Medical Center
🇺🇸Cape Girardeau, Missouri, United States
California Pacific Medical Center - California Campus
🇺🇸San Francisco, California, United States
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center
🇺🇸Grand Junction, Colorado, United States
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center
🇺🇸Orange, California, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
🇺🇸Alton, Illinois, United States
Kauai Medical Clinic
🇺🇸Lihue, Hawaii, United States
Good Samaritan Regional Health Center
🇺🇸Mount Vernon, Illinois, United States
CCOP - Grand Rapids
🇺🇸Grand Rapids, Michigan, United States
Middletown Regional Hospital
🇺🇸Franklin, Ohio, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
🇺🇸Seattle, Washington, United States
Midwest Hematology Oncology Group, Incorporated
🇺🇸Saint Louis, Missouri, United States
Highland Hospital of Rochester
🇺🇸Rochester, New York, United States
CCOP - St. Louis-Cape Girardeau
🇺🇸Saint Louis, Missouri, United States
David C. Pratt Cancer Center at St. John's Mercy
🇺🇸Saint Louis, Missouri, United States
United States Air Force Medical Center - Wright-Patterson
🇺🇸Wright-Patterson Afb, Ohio, United States
Ruth G. McMillan Cancer Center at Greene Memorial Hospital
🇺🇸Xenia, Ohio, United States
Evergreen Hematology and Oncology, PS
🇺🇸Spokane, Washington, United States
Cancer Center of Kansas, PA - Medical Arts Tower
🇺🇸Wichita, Kansas, United States
Cancer Center of Kansas, PA - Pratt
🇺🇸Pratt, Kansas, United States