A Phase II Randomized, Double-Blinded Evaluation of Oral Everolimus (RAD001) Plus Bevacizumab vs. Oral Placebo Plus Bevacizumab in the Treatment of Recurrent or Persistent Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
OBJECTIVES:
Primary
- To compare the progression-free survival hazard ratio in patients with persistent or
recurrent ovarian epithelial, fallopian tube, or primary peritoneal cancer treated with
bevacizumab with vs without everolimus.
Secondary
- To determine the nature and degree of toxicity of these regimens.
- To compare the progression-free and overall survival of patients with measurable
disease vs those with detectable (non-measurable) disease.
- To estimate the proportion of patients with measurable disease who have objective tumor
response to treatment.
- To provide descriptive information about CA-125 response by regimen and, where
possible, by objective tumor response.
OUTLINE: This is a multicenter study. Patients are stratified according to their
platinum-free interval (≤ 182 days vs > 182 days), measurable disease status (measurable vs
non-measurable or "detectable" disease), and prior treatment with bevacizumab/aflibercept
(no vs yes). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive bevacizumab IV over 30-90 minutes on days 1 and 15 and oral
everolimus once daily on days 1-28.
- Arm II: Patients receive bevacizumab as in arm I and oral placebo once daily on days
1-28.
In both arms, courses repeat every 28 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, Masking: Double-Blind, Primary Purpose: Treatment
Progression-free survival hazard ratio
No
William P. Tew, MD
Study Chair
Memorial Sloan-Kettering Cancer Center
United States: Food and Drug Administration
GOG-0186G
NCT00886691
December 2010
Name | Location |
---|---|
Memorial Sloan Kettering Cancer Center | New York, New York 10021 |
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Iowa Hospitals and Clinics | Iowa City, Iowa 52242 |
Abington Memorial Hospital | Abington, Pennsylvania 19001 |
Abramson Cancer Center of the University of Pennsylvania | Philadelphia, Pennsylvania 19104-4283 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
LDS Hospital | Salt Lake City, Utah 84143 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
Cedars-Sinai Medical Center | Los Angeles, California 90048 |
Baystate Medical Center | Springfield, Massachusetts 01199 |
Carolinas Medical Center | Charlotte, North Carolina 28232-2861 |
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 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
AnMed Health Cancer Center | Anderson, South Carolina 29621 |
Duke University Medical Center | Durham, North Carolina 27710 |
Nebraska Methodist Hospital | Omaha, Nebraska 68114 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Riverside Methodist Hospital | Columbus, Ohio 43214 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Hillcrest Hospital Cancer Center | Mayfield Heights, Ohio 44124 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
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 |
Saint John's Hospital | Springfield, Missouri 65804 |
Cox Medical Center | Springfield, Missouri 65807 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
University of California Medical Center At Irvine-Orange Campus | Orange, California 92868 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
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 |
Carle Foundation - Carle Cancer Center | Urbana, Illinois 61801 |
Cleveland Clinic Cancer Center/Fairview Hospital | Cleveland, Ohio 44111 |
Baylor All Saints Medical Center at Fort Worth | Fort Worth, Texas 76104 |