Conditions: Ovarian Cancer Fallopian Tube Neoplasms Peritoneal Neoplasm
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 153
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Enzastaurin: 1125 milligram (mg) loading dose then 500 mg oral tablet, daily for six 21-day cycles or up to 3 years

Carboplatin: Area under the concentration time curve (AUC) 5 intravenous (IV), every (q) 21 days for six 21-day cycles

Paclitaxel:175 milligrams/square meter (mg/m²) IV, q21 days for six 21-day cycles arm 2: Carboplatin: AUC5 IV, q21 days for six 21-day cycles

Paclitaxel: 175 mg/m², IV, q21 days for six 21-day cycles

Placebo: oral tablet

Interventions: intervention 1: enzastaurin intervention 2: carboplatin intervention 3: paclitaxel intervention 4: placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol document: