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
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 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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression Free Survival (PFS)
6 months
No
Robert L. Coleman, MD
Study Chair
M.D. Anderson Cancer Center
United States: Food and Drug Administration
CDR0000638595
NCT00872989
March 2010
Name | Location |
---|---|
Fred Hutchinson Cancer Research Center | Seattle, Washington 98109 |
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
CCOP - Wichita | Wichita, Kansas 67214-3882 |
St. Mary's Regional Cancer Center at St. Mary's Hospital and Medical Center | Grand Junction, Colorado 81502 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Grand Rapids | Grand Rapids, Michigan 49503 |
Cancer Research Center of Hawaii | Honolulu, Hawaii 96813 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
CCOP - St. Louis-Cape Girardeau | Saint Louis, Missouri 63141 |
University of California Davis Cancer Center | Sacramento, California 95817 |
Arizona Cancer Center at University of Arizona Health Sciences Center | Tucson, Arizona 85724 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus | Seattle, Washington 98104 |
Hulston Cancer Center at Cox Medical Center South | Springfield, Missouri 65807 |
St. John's Regional Health Center | Springfield, Missouri 65804 |
Via Christi Cancer Center at Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Alaska Regional Hospital Cancer Center | Anchorage, Alaska 99508 |
Saint Anthony's Hospital at Saint Anthony's Health Center | Alton, Illinois 62002 |
Good Samaritan Regional Health Center | Mt. Vernon, Illinois 62864 |
Battle Creek Health System Cancer Care Center | Battle Creek, Michigan 49017 |
Munson Medical Center | Traverse City, Michigan 49684 |
David C. Pratt Cancer Center at St. John's Mercy | St. Louis, Missouri 63141 |
Hematology-Oncology Centers of the Northern Rockies - Billings | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
St. Peter's Hospital | Helena, Montana 59601 |
Kalispell Regional Medical Center | Kalispell, Montana 59901 |
Glacier Oncology, PLLC | Kalispell, Montana 59901 |
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center | Missoula, Montana 59802 |
Montana Cancer Specialists at Montana Cancer Center | Missoula, Montana 59802 |
Wayne Memorial Hospital, Incorporated | Goldsboro, North Carolina 27534 |
Olympic Hematology and Oncology | Bremerton, Washington 98310 |
Skagit Valley Hospital Cancer Care Center | Mt. Vernon, Washington 98273 |
University Cancer Center at University of Washington Medical Center | Seattle, Washington 98195 |
Harborview Medical Center | Seattle, Washington 98104 |
Group Health Central Hospital | Seattle, Washington 98104 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Greenebaum Cancer Center at University of Maryland Medical Center | Baltimore, Maryland 21201 |
Tulane Cancer Center Office of Clinical Research | Alexandria, Louisiana 71315-3198 |
Butterworth Hospital at Spectrum Health | Grand Rapids, Michigan 49503-2560 |
CCOP - Nevada Cancer Research Foundation | Las Vegas, Nevada 89109-2306 |
M. D. Anderson Cancer Center at University of Texas | Houston, Texas 77030-4009 |
Chao Family Comprehensive Cancer Center at University of California Irvine Medical Center | Orange, California 92868 |
Fox Chase Cancer Center - Philadelphia | Philadelphia, Pennsylvania 19111-2497 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Peninsula Medical Center | Burlingame, California 94010 |
Sutter Health - Western Division Cancer Research Group | Greenbrae, California 94904 |
Alta Bates Summit Medical Center - Summit Campus | Oakland, California 94609 |
California Pacific Medical Center - California Campus | San Francisco, California 94118 |
Sutter Solano Medical Center | Vallejo, California 94589 |
St. Francis Hospital and Health Centers - Beech Grove Campus | Beech Grove, Indiana 46107 |
Cancer Center of Kansas, PA - Dodge City | Dodge City, Kansas 67801 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Saint Francis Medical Center | Cape Girardeau, Missouri 63701 |
Highland Hospital of Rochester | Rochester, New York 14620 |
Samaritan North Cancer Care Center | Dayton, Ohio 45415 |
Grandview Hospital | Dayton, Ohio 45405 |
David L. Rike Cancer Center at Miami Valley Hospital | Dayton, Ohio 45409 |
Good Samaritan Hospital | Dayton, Ohio 45406 |
Blanchard Valley Medical Associates | Findlay, Ohio 45840 |
Charles F. Kettering Memorial Hospital | Kettering, Ohio 45429 |
Middletown Regional Hospital | Middletown, Ohio 45044 |
UVMC Cancer Care Center at Upper Valley Medical Center | Troy, Ohio 45373-1300 |
Ruth G. McMillan Cancer Center at Greene Memorial Hospital | Xenia, Ohio 45385 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Minor and James Medical, PLLC | Seattle, Washington 98104 |
Polyclinic First Hill | Seattle, Washington 98122 |
Welch Cancer Center at Sheridan Memorial Hospital | Sheridan, Wyoming 82801 |
Montrose Memorial Hospital Cancer Center | Montrose, Colorado 81401 |
Highland General Hospital | Oakland, California 94602 |
Regional Cancer Center at Singing River Hospital | Pascagoula, Mississippi 39581 |
Alta Bates Summit Comprehensive Cancer Center | Berkeley, California 94704 |
Reid Hospital & Health Care Services | Richmond, Indiana 47374 |
Cancer Center of Kansas, PA - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas, PA - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Cancer Center of Kansas, PA - Kingman | Kingman, Kansas 67068 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Cancer Center of Kansas, PA - Liberal | Liberal, Kansas 67905 |
Cancer Center of Kansas, PA - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas, PA - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas, PA - Pratt | Pratt, Kansas 67124 |
Tammy Walker Cancer Center at Salina Regional Health Center | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Salina | Salina, Kansas 67401 |
Cancer Center of Kansas, PA - Wellington | Wellington, Kansas 67152 |
Cancer Center of Kansas, PA - Wichita | Wichita, Kansas 67214 |
Associates in Womens Health, PA - North Review | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas, PA - Winfield | Winfield, Kansas 67156 |
Billings Clinic - Downtown | Billings, Montana 59107-7000 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Great Falls Clinic - Main Facility | Great Falls, Montana 59405 |
Sletten Cancer Institute at Benefis Healthcare | Great Falls, Montana 59405 |
Wayne Hospital | Greenville, Ohio 45331 |
Clinton Memorial Hospital | Wilmington, Ohio 45177 |
St. Joseph Cancer Center | Bellingham, Washington 98225 |
Columbia Basin Hematology | Kennewick, Washington 99336 |
Harrison Poulsbo Hematology and Onocology | Poulsbo, Washington 98370 |
Evergreen Hematology and Oncology, PS | Spokane, Washington 99218 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Rocky Mountain Oncology | Casper, Wyoming 82609 |
Queen's Cancer Institute at Queen's Medical Center | Honolulu, Hawaii 96813 |
Tucker Center for Cancer Care at Orange Regional Medical Center | Middletown, New York 10940-4199 |
Pardee Memorial Hospital | Hendersonville, North Carolina 28791 |
Lacks Cancer Center at Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Doctors Medical Center - San Pablo Campus | San Pablo, California 94806 |
St. Vincent Healthcare Cancer Care Services | Billings, Montana 59101 |
Midwest Hematology Oncology Group, Incorporated | Saint Louis, Missouri 63109 |
Providence Cancer Center at Providence Hospital | Mobile, Alabama 36608 |
Contra Costa Regional Medical Center | Martinez, California 94553-3156 |
Tibotec Therapeutics - Division of Ortho Biotech Products, LP | Marysville, California 95901 |
El Camino Hospital Cancer Center | Mountain View, California 94040 |
Tahoe Forest Cancer Center | Truckee, California 96161 |
Kapiolani Medical Center at Pali Momi | Aiea, Hawaii 96701 |
Kapiolani Medical Center for Women and Children | Honolulu, Hawaii 96826 |
Straub Clinic and Hospital, Incorporated | Honolulu, Hawaii 96813 |
Hawaii Medical Center - East | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Kuakini | Honolulu, Hawaii 96817 |
OnCare Hawaii, Incorporated - Lusitana | Honolulu, Hawaii 96813 |
Maui Memorial Medical Center | Wailuku, Hawaii 96793 |
Mercy General Health Partners | Muskegon, Michigan 49443 |
United States Air Force Medical Center - Wright-Patterson | Wright-Patterson AFB, Ohio 45433-5529 |
U.T. Medical Center Cancer Institute | Knoxville, Tennessee 37920-6999 |
University of Colorado Cancer Center at UC Health Sciences Center | Aurora, Colorado 80045 |
Caritas Holy Family Hospital | Methuen, Massachusetts 01844 |
Falck Cancer Center at Arnot Ogden Medical Center | Elmira, New York 14905 |
Roy and Patricia Disney Family Cancer Center at Providence Saint Joseph Medical Center | Burbank, California 91505 |
Shaw Regional Cancer Center | Edwards, Colorado 81632 |
San Luis Valley Regional Medical Center | Alamosa, Colorado 81101 |
Valley View Hospital Cancer Center | Glenwood Springs, Colorado 81601 |
Castle Medical Center | Kailua, Hawaii 96734 |
Kauai Medical Clinic | Lihue, Hawaii 96766 |
Central Dupage Cancer Center | Warrenville, Illinois 60555 |
NEA Medical Center - Stadium Boulevard | Jonesboro, Arkansas 72401 |