A Randomized Phase IIB Evaluation of Weekly Paclitaxel (NSC #673089) Plus Pazopanib (NSC #737754) (IND #75648) Versus Weekly Paclitaxel Plus Placebo in the Treatment of Persistent or Recurrent Epithelial Ovarian, Fallopian Tube or Primary Peritoneal Carcinoma
PRIMARY OBJECTIVES:
I. To estimate the progression-free survival hazard ratio of the combination of weekly
paclitaxel and pazopanib (pazopanib hydrochloride) compared to weekly paclitaxel and placebo
in patients with persistent or recurrent ovarian, fallopian tube, or primary peritoneal
cancer.
SECONDARY OBJECTIVES:
I. To determine the frequency and severity of adverse events as assessed by CTCAE.
II. To estimate and compare the proportion of patients responding to therapy by RECIST,
CA125 response, the overall survival (OS), and the duration of response in each arm.
EXPLORATORY OBJECTIVES:
I. To explore the association between plasma cytokines and angiogenic markers and
progression-free and overall survival.
II. To explore the association between single-nucleotide polymorphisms (SNPs) and
progression-free and overall survival.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive paclitaxel IV over 1 hour on days 1, 8, and 15 and placebo orally
(PO) daily on days 1-28.
ARM II: Patients receive paclitaxel as in arm I and pazopanib hydrochloride PO daily on days
1-28.
In both arms, treatment repeats every 28 days in the absence of disease progression or
unacceptable toxicity.
After completion of study therapy, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Efficacy of each treatment regimen
Evaluated using the Cox proportional hazards and stratified by platinum-free interval, measurable disease status, and prior use of bevacizumab. Maximum likelihood estimate of the logarithm of the hazard ratio of Arm 2 to Arm 1 for disease progression or death (PFS endpoint) will be calculated.
Up to 5 years
No
Debra Richardson
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-03635
NCT01468909
December 2011
Name | Location |
---|---|
Johns Hopkins University | Baltimore, Maryland 21205 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
Washington University School of Medicine | Saint Louis, Missouri 63110 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
University of Washington Medical Center | Seattle, Washington 98195-6043 |
Tacoma General Hospital | Tacoma, Washington 98405 |
Hurley Medical Center | Flint, Michigan 48503 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Group Health Cooperative | Seattle, Washington 98112 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
Cancer Center of Kansas - Chanute | Chanute, Kansas 66720 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Newton | Newton, Kansas 67114 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Munson Medical Center | Traverse City, Michigan 49684 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
University of South Alabama Mitchell Cancer Institute | Mobile, Alabama 36604 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Beebe Medical Center | Lewes, Delaware 19958 |
Mecosta County Medical Center | Big Rapids, Michigan 49307 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Cancer Center of Kansas - Fort Scott | Fort Scott, Kansas 66701 |
Cancer Center of Kansas-Independence | Independence, Kansas 67301 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Marshfield Clinic Cancer Care at Regional Cancer Center | Eau Claire, Wisconsin 54701 |
Marshfield Clinic - Weston Center | Weston, Wisconsin 54476 |
Marshfield Clinic - Wisconsin Rapids Center | Wisconsin Rapids, Wisconsin 54494 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Greater Baltimore Medical Center | Baltimore, Maryland 21204 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Cancer Centers of the Carolinas - Seneca | Seneca, South Carolina 29672 |
Cancer Centers of the Carolinas - Spartanburg | Spartanburg, South Carolina 29307 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
University of Connecticut | Farmington, Connecticut 06032 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
University of Texas Southwestern Medical Center | Dallas, Texas |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Northwest Hospital | Seattle, Washington 98133 |
Central Georgia Gynecologic Oncology | Macon, Georgia 31201 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
Harrison Medical Center | Bremerton, Washington 98310 |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
University of Hawaii | Honolulu, Hawaii 96813 |
McFarland Clinic | Ames, Iowa 50010 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Kingman | Kingman, Kansas 67068 |
Cancer Center of Kansas - Parsons | Parsons, Kansas 67357 |
Cancer Center of Kansas - Pratt | Pratt, Kansas 67124 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Michigan Cancer Research Consortium Community Clinical Oncology Program | Ann Arbor, Michigan 48106 |
Oakwood Hospital | Dearborn, Michigan 48123 |
Saint John Hospital and Medical Center | Detroit, Michigan 48236 |
Grand Rapids Clinical Oncology Program | Grand Rapids, Michigan 49503 |
Saint Mary's Health Care | Grand Rapids, Michigan 49503 |
Spectrum Health at Butterworth Campus | Grand Rapids, Michigan 49503 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
Mercy Health Partners-Mercy Campus | Muskegon, Michigan 49443 |
Saint Joseph Mercy Oakland | Pontiac, Michigan 48341-2985 |
Saint Joseph Mercy Port Huron | Port Huron, Michigan 48060 |
Saint Mary's of Michigan | Saginaw, Michigan 48601 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
Freeman Health System | Joplin, Missouri 64804 |
Ozark Health Ventures LLC dba Cancer Research for The Ozarks Springfield | Springfield, Missouri 65802 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Kettering Medical Center | Kettering, Ohio 45429 |
Greenville CCOP | Greenville, South Carolina 29615 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Saint Vincent Hospital | Green Bay, Wisconsin 54301 |
Green Bay Oncology Limited at Saint Mary's Hospital | Green Bay, Wisconsin 54303 |
Green Bay Oncology at Saint Vincent Hospital | Green Bay, Wisconsin 54301-3526 |
Bay Area Medical Center | Marinette, Wisconsin 54143 |
Marshfield Clinic-Minocqua Center | Minocqua, Wisconsin 54548 |
Marshfield Clinic at James Beck Cancer Center | Rhinelander, Wisconsin 54501 |
Marshfield Clinic-Rice Lake Center | Rice Lake, Wisconsin 54868 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Women's Cancer Associates | Saint Petersburg, Florida 33701 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Lahey Clinic Medical Center | Burlington, Massachusetts 01805 |
Cancer Center of Kansas-Liberal | Liberal, Kansas 67901 |
Cancer Centers of the Carolinas - Faris | Greenville, South Carolina 29605 |
Holy Family Memorial Hospital | Manitowoc, Wisconsin 54221 |
Marshfield Clinic Cancer Care at Saint Michael's Hospital | Stevens Point, Wisconsin 54481 |
Hawaii Minority Based CCOP | Honolulu, Hawaii 96813 |
Maine Medical Center-Bramhall Campus | Portland, Maine 04102 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Gynecologic Oncology Group of Arizona | Phoenix, Arizona 85012 |
Sudarshan K Sharma MD Limted-Gynecologic Oncology | Hinsdale, Illinois 60521 |
Saint Vincent Oncology Center | Indianapolis, Indiana 46260 |
PeaceHealth Medical Group PC | Bellingham, Washington 98226 |
Skagit Valley Hospital Regional Cancer Care Center | Mount Vernon, Washington 98274 |
Olympic Medical Cancer Care Center | Sequim, Washington 98384 |
Rockwood Cancer Treatment Center | Spokane, Washington 99204 |
Providence Saint Mary Regional Cancer Center | Walla Walla, Washington 99362 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Bronson Battle Creek | Battle Creek, Michigan 49017 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Women's Cancer Care Associates LLC | Albany, New York 12208 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
Baylor All Saints Medical Center at Fort Worth | Fort Worth, Texas 76104 |
Gynecologic Oncology Associates-Newport Beach | Newport Beach, California 92663 |