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

Lilly

Status and phase: Completed; Phase 2

Conditions: Fallopian Tube Neoplasms; Peritoneal Neoplasm; Ovarian Cancer

Treatments: Drug: carboplatin; Drug: enzastaurin; Drug: placebo; Drug: paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT00391118

H6Q-MC-S019 (Other Identifier)

10708

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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153 participants in 2 patient groups, including a placebo group

A (Part A)

Experimental group

Description:

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

Treatment:

Drug: paclitaxel

Drug: enzastaurin

Drug: carboplatin

B (Part B)

Placebo Comparator group

Description:

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

Treatment:

Drug: paclitaxel

Drug: placebo

Drug: carboplatin