A Phase II Evaluation of Temsirolimus (CCI-779) (NCI Supplied Agent: 683864, IND #61010) in Combination with Carboplatin and Paclitaxel followed by Temsirolimus Consolidation as First-line Therapy in the Treatment of Clear Cell Carcinoma of the Ovary.
Principal Investigator
John Farley, MD
Status
Closed to Accrual
Date Opened To Accrual
August 30 2010
Date Closed to Accrual
January 06 2014
Disease Site
Gynecologic [GY]
Ovarian
Phase
II
Developmental Therapeutics
No
Primary Objective
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)
Patients in Japan
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.
Patient Population
Target Accrual
45
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.