drugset / Trial / NCT00391118

Comparing Two Treatments for Ovarian Cancer: Standard Chemotherapy Plus Enzastaurin, or Placebo ("Sugar Pill")

NCT00391118

Phase 2 Completed 153 enrolled Eli Lilly and Company
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Participants with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many participants the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many participants. This trial will try to address the question: Can we delay the time till the tumor grows again by adding a 3rd drug to the standard therapy? To answer this question, participants will, by chance, either get the experimental drug enzastaurin or a "dummy pill" (placebo) during the chemotherapy and for up to 3 years after chemotherapy. Participants and physicians will not know if a participant gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of participants with tumor growth at a specific time point will be compared between the two treatments.

Timeline

Start
2006-11
Primary completion
2010-04
Completion
2012-07

Drugs

EvaluationDrugModalityDoseRoute
Subject enzastaurin Small molecule 500 mg Oral
Background Carboplatin Small molecule Intravenous
Background Paclitaxel Small molecule 175 mg/m2 Intravenous