A randomized phase III trial of maintenance chemotherapy comparing 12 monthly cycles of single agent paclitaxel or ct-2103 (ind# 70177) versus no treatment until documented relapse in women with advanced ovarian, primary peritoneal or fallopian tube cancer who achieve a complete clinical response to primary platinum/taxane chemotherapy
Principal Investigator
Larry Copeland, MD
Status
Closed to Accrual
Date Opened To Accrual
March 21 2005
Date Closed to Accrual
January 13 2014
Disease Site
Gynecologic [GY]
Ovarian
Phase
III
Developmental Therapeutics
No
Primary Objective
To determine whether CT-2103 or paclitaxel, administered to women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy (“consolidation/maintenance therapy”) will reduce the death rate, compared to re-treatment at the time of documented disease progression.
To determine if, in this clinical setting, CT-2103 produces a more favorable toxicity profile (with a particular focus on peripheral neuropathy as measured by the GOG NTX4) and superior quality-of-life (as measured by the FACT-O), compared to paclitaxel.
Patient Population
Women with advanced ovarian, primary peritoneal or fallopian tube cancer who have attained a clinically-defined complete response to primary platinum/taxane-based chemotherapy.
Target Accrual
1100
Patient Study Webpage
There is no available patient study webpage available for this trial at this time.