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

• Progression Free Survival [ Time Frame: baseline to measured progressive disease evaluated at 2 and 3 years ] [ Designated as safety issue: No ]
• To compare the safety of the two treatments [ Time Frame: every cycle ] [ Designated as safety issue: Yes ]
• To assess if biological markers in the tumors can be identified, which could enable to predict, who could profit from treatment with enzastaurin [ Time Frame: baseline, cycle 2, end of study ] [ Designated as safety issue: No ]
• Pharmacokinetics [ Time Frame: cycle 1, cycle 2 ] [ Designated as safety issue: No ]

• Compare other efficacy measures between the 2 treatments, like tumor shrinkage in patients, or average time till the tumor grows again, during and after the treatment period
• To compare the safety of the two treatments during the treatment phase
• To assess, after the treatment period, if biological markers in the tumors can be identified, which could enable to predict, who could profit from treatment with enzastaurin
• To measure potential interactions between the chemotherapeutic drugs and enzastaurin
• Measure enzastaurin concentration in the blood, while taking the drug

Patients with ovarian cancer usually get the drugs carboplatin and paclitaxel as initial treatment. In many patients the tumor will shrink, or even disappear, after treatment with these drugs. But, unfortunately, the tumor will grow again in many patients. 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, patients 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. Patients and physicians will not know, if a patient gets enzastaurin or placebo (double-blinded trial). After a predefined time, the treatment will be uncovered, and the number of patients with tumor growth at a specific time point will be compared between the two treatments.

• Ovarian Cancer
• Fallopian Tube Neoplasms
• Peritoneal Neoplasm

• Drug: enzastaurin
  1125 mg loading dose then 500 mg, oral, daily, six 21 day cycles or up to 3 years
  Other Name: LY317615
• Drug: carboplatin
  AUC 5, IV, q 21 days, six 21 day cycles
• Drug: paclitaxel
  175 mg/m2, IV, q 21 days, six 21 day cycles
• Drug: placebo
  oral, daily

• Experimental: A
  Interventions:

  • Drug: enzastaurin
  • Drug: carboplatin
  • Drug: paclitaxel
• Placebo Comparator: B
  Interventions:

  • Drug: carboplatin
  • Drug: paclitaxel
  • Drug: placebo

Inclusion Criteria:

• Patients must have specific stages of disease, known as FIGO stages IIB, IIC, III or IV
• Organ functions (blood, renal, liver, cardiac) must meet specific requirements.
• Patients, who could become pregnant, must take care not to become pregnant during the study participation and for 6 months after study discontinuation
• Patients must give written consent for study participation.

Exclusion Criteria:

• Patients received any experimental drug within the last 30 days.
• Patients received any prior chemotherapy or other drug therapy for the current disease.
• Patients receive any other treatment for the cancer during study participation.
• Patients are unable to discontinue concurrent administration of carbamazepine, phenobarbital, or phenytoin.
• Patients are pregnant, breast feeding, or not using adequate contraceptive methods to prevent pregnancy.