A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: NSC# 683864, IND# 61010) in Combination With Carboplatin and Paclitaxel Followed by Temsirolimus (CCI-779) Consolidation as First-Line Therapy in the Treatment of Stage III-IV Clear Cell Carcinoma of the Ovary
PRIMARY OBJECTIVES:
I. To assess the activity of the study regimen as measured by the proportion of patients who
are alive and progression-free for at least 12 months after study entry in patients with
newly diagnosed Stage III or IV clear cell ovarian cancer in the following populations:
patients in the U.S. and worldwide (outside of Japan) and patients in Japan.
II. To compare progression-free survival in newly diagnosed Stage III or IV clear cell
ovarian cancer patients in patients in the U.S. and worldwide (outside of Japan) versus
patients in Japan.
SECONDARY OBJECTIVES:
I. To characterize the duration of overall survival and progression-free survival in each
population.
II. To examine the frequency and severity of adverse events as assessed by CTCAE version 4
in each population.
III. To estimate the rate of objective tumor response in patients with measurable disease.
(09/04/12)
TERTIARY OBJECTIVES:
I. To explore whether immunohistochemical (IHC) expression of components of the mTOR
signaling pathway (PTEN, total and phosphorylated Akt, as well as, ABCC3 (MRP3), AB CF2,
cyclin E, and VEGF) are associated with outcome, nationality or clinical characteristics.
II. To explore whether there is any differences in differential gene expression profiles
between U.S. and worldwide (outside of Japan) versus Japanese patients.
OUTLINE: This is a multicenter study. Patients are stratified according to surgical extent
(optimal vs suboptimal).
Patients receive paclitaxel intravenously (IV) over 3 hours and carboplatin IV over 30
minutes on day 1 and temsirolimus IV on days 1 and 8. Treatment repeats every 3 weeks for 6
courses. Patients then receive consolidation therapy comprising temsirolimus IV on days 1,
8, and 15. For circumstances in which docetaxel should be substituted for paclitaxel,
docetaxel will be given IV over 1 hour. Treatment repeats every 3 weeks for 11 courses in
the absence of disease progression or unacceptable toxicity. Patients may undergo sample
collection for exploratory studies.
After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Progression-free survival
Will be characterized with Kaplan-Meier plots.
12 months
No
John Farley
Principal Investigator
Gynecologic Oncology Group
United States: Food and Drug Administration
NCI-2011-02653
NCT01196429
August 2010
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
University of Mississippi Medical Center | Jackson, Mississippi 39216-4505 |
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 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Memorial Hospital of South Bend | South Bend, Indiana 46601 |
LDS Hospital | Salt Lake City, Utah 84143 |
Rush University Medical Center | Chicago, Illinois 60612-3824 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Hartford Hospital | Hartford, Connecticut 06102-5037 |
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 |
Group Health Cooperative | Seattle, Washington 98112 |
University of Wisconsin Hospital and Clinics | Madison, Wisconsin 53792-0001 |
Winthrop University Hospital | Mineola, New York 11501 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium | Seattle, Washington 98109 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Cancer Care Northwest - Spokane South | Spokane, Washington 99202 |
Methodist Estabrook Cancer Center | Omaha, Nebraska 68114-4199 |
Elkhart General Hospital | Elkhart, Indiana 46515 |
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University Medical Center | Columbus, Ohio 43210-1240 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Saint Joseph Mercy Hospital | Ann Arbor, Michigan 48106 |
Geisinger Medical Group | State College, Pennsylvania 16801 |
Wenatchee Valley Medical Center | Wenatchee, Washington 98801-2028 |
Seattle Cancer Care Alliance | Seattle, Washington 98109 |
Genesys Regional Medical Center | Grand Blanc, Michigan 48439-8066 |
Pacific Gynecology Specialists | Seattle, Washington 98104 |
University of North Carolina | Chapel Hill, North Carolina 27599 |
Duke University Medical Center | Durham, North Carolina 27710 |
Northwestern University | Chicago, Illinois 60611 |
Saint Alphonsus Regional Medical Center | Boise, Idaho 83706 |
Case Western Reserve University | Cleveland, Ohio 44106 |
Indiana University Medical Center | Indianapolis, Indiana 46202 |
Northwest Hospital | Seattle, Washington 98133 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Florida Hospital | Orlando, Florida 32803 |
Memorial Health University Medical Center | Savannah, Georgia 31404 |
Harrison Medical Center | Bremerton, Washington 98310 |
University of Chicago Comprehensive Cancer Center | Chicago, Illinois 60637-1470 |
M D Anderson Cancer Center | Houston, Texas 77030 |
University of Southern California | Los Angeles, California 90033 |
Northern Indiana Cancer Research Consortium | South Bend, Indiana |
University of Cincinnati | Cincinnati, Ohio 45267-0502 |
Froedtert and the Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Saint Francis Hospital and Medical Center | Hartford, Connecticut 06105 |
The Hospital of Central Connecticut | New Britain, Connecticut 06050 |
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 |
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 |
Allegiance Health | Jackson, Michigan 49201 |
Sparrow Hospital | Lansing, Michigan 48912 |
Saint Mary Mercy Hospital | Livonia, Michigan 48154 |
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 |
Lakeland Hospital | St. Joseph, Michigan 49085 |
Saint John Macomb-Oakland Hospital | Warren, Michigan 48093 |
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 |
Geisinger Wyoming Valley | Wilkes-Barre, Pennsylvania 18711 |
Harrison Bremerton Hematology and Oncology | Bremerton, Washington 98310 |
Swedish Medical Center-First Hill | Seattle, Washington 98122-4307 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Cancer Care Associates-Yale | Tulsa, Oklahoma 74136-1929 |
Women and Infants Hospital | Providence, Rhode Island 02905 |
Lake University Ireland Cancer Center | Mentor, Ohio 44060 |
Stony Brook University Medical Center | Stony Brook, New York 11794 |
Lahey Clinic Medical Center | Burlington, Massachusetts 01805 |
Elkhart Clinic | Elkhart, Indiana 46515 |
University of Colorado Cancer Center - Anschutz Cancer Pavilion | Aurora, Colorado 80045 |
Michiana Hematology Oncology PC-Elkhart | Elkhart, Indiana 46514 |
Michiana Hematology Oncology PC-Plymouth | Plymouth, Indiana 46563 |
Michiana Hematology Oncology PC-South Bend | South Bend, Indiana 46601 |
Michiana Hematology Oncology-PC Westville | Westville, Indiana 46391 |
Michiana Hematology Oncology PC-Niles | Niles, Michigan 49120 |
Utah Valley Regional Medical Center | Provo, Utah 84603 |
Dixie Medical Center Regional Cancer Center | Saint George, Utah 84770 |
Women's Cancer Center of Nevada | Las Vegas, Nevada 89109 |
Central DuPage Hospital Cancer Center | Warrenville, Illinois 60555 |
Providence Regional Cancer Partnership | Everett, Washington 98201 |
Palo Alto Medical Foundation-Gynecologic Oncology | Mountain View, California 94040 |
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 |
Michiana Hematology Oncology PC-Mishawaka | Mishawaka, Indiana 46545-1470 |
Marie Yeager Cancer Center | Saint Joseph, Michigan 49085 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Gynecologic Oncology Group | Philadelphia, Pennsylvania 19103 |
Geisinger Medical Center-Cancer Center Hazelton | Hazleton, Pennsylvania 18201 |
Community Howard Regional Health | Kokomo, Indiana 46904 |
Indiana University Health La Porte Hospital | La Porte, Indiana 46350 |
Saint Joseph Regional Medical Center-Mishawaka | Mishawaka, Indiana 46545-1470 |
Saint Joseph's Hospital and Medical Center | Phoenix, Arizona 85013 |
Harrison Poulsbo Hematology and Oncology | Poulsbo, Washington 98370 |
Walter Reed Army Medical Center-Olney | Olney, Maryland 20832 |