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

• Status: Completed
• Trial end date: 2012-07-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Albumin-Bound Paclitaxel; Carboplatin; Paclitaxel

Criteria

Inclusion Criteria:

• Participants must have specific stages of disease, known as Fédération Internationale de Gynécologie et d'Obstétrique (FIGO) stages IIB, IIC, III or IV

• Organ functions (blood, renal, liver, cardiac) must meet specific requirements.

• Participants who could become pregnant must take care not to become pregnant during the study participation and for 6 months after study discontinuation

• Participants must give written consent for study participation.

Exclusion Criteria:

• Participants received any experimental drug within the last 30 days.

• Participants received any prior chemotherapy or other drug therapy for the current disease.

• Participants receive any other treatment for the cancer during study participation.

• Participants are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.

• Participants are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.