Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 117
Healthy volunteers: no

Brief summary:
This study will evaluate the addition of enzastaurin to 5-FU (5-fluorouracil)/LV (leucovorin) plus bevacizumab in the maintenance of best response obtained with 6 cycles of first-line therapy consisting of 5-FU/LV + oxaliplatin (FOLFOX) or 5-FU/LV + irinotecan (FOLFIRI), plus bevacizumab in patients with Metastatic Colorectal Cancer.

Detailed description:

Arms:
arm 1: 5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with enzastaurin arm 2: 5-fluorouracil/leucovorin (5-FU/LV) plus bevacizumab (Bev) in combination with placebo

Interventions: intervention 1: Enzastaurin intervention 2: Placebo intervention 3: Leucovorin (LV) intervention 4: 5-fluorouracil (5-FU) intervention 5: Bevacizumab (Bev)
Intervention descriptions: intervention 1: 1125 milligram (mg) loading dose, then 250 mg twice daily, oral up to 1 year (yr) or until progressive disease intervention 2: oral, daily (up to 1 yr or until progressive disease) intervention 3: 400 milligram per meter squared (mg/m\^2) intravenously (IV), Day 1 of 14 day cycle (up to 1 yr or until progressive disease) intervention 4: 400 mg/m\^2 bolus then 2400 mg/m\^2 IV over 46 hours, Day 1 of 14 day cycle (up to 1 yr or until progressive disease) intervention 5: 5 milligram per kilogram (mg/kg) IV, Day 1 of 14 day cycle (up to 1 yr or until progressive disease)

Protocol document: