NCT00391118

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

A Randomized, Phase 2, Placebo-Controlled, Double-Blinded Study With and Without Enzastaurin in Combination With Paclitaxel and Carboplatin as First-Line Treatment, Followed by Maintenance Treatment in Advanced Ovarian Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 153 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Ovarian Cancer
• Fallopian Tube Neoplasms
• Peritoneal Neoplasm

Interventions

Type	Name	Description
DRUG	enzastaurin
DRUG	carboplatin
DRUG	paclitaxel
DRUG	placebo

Timeline

• Start date: 2006-11-01
• Primary completion: 2010-04-01
• Completion: 2012-07-01
• First posted: 2006-10-23
• Last updated: 2020-10-19
• Results posted: 2020-10-19

Locations

15 sites across 5 countries: Belgium, Germany, Poland, Russia, Spain