GOG-0212

Terminated

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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

Terminated

Closed to Accrual

January 13, 2014

Closed to Accrual & Treatment

February 7, 2015

Complete

January 28, 2023

Terminated

January 28, 2023


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.