Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 376
Healthy volunteers: no

Brief summary:
This will be a randomized, open-label, multicenter, Phase II study with primary objectives to assess whether expression of select chemotherapy markers is associated with progression-free survival (PFS) in participants treated with bevacizumab plus leucovorin, 5-fluorouracil, and oxaliplatin (mFOLFOX6) or bevacizumab plus leucovorin, 5-fluorouracil, and irinotecan (FOLFIRI). The study population will consist of participants with first-line mCRC.

Detailed description:

Arms:
arm 1: Participants will receive bevacizumab plus mFOLFOX6 by intravenous (IV) infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity. Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to oxaliplatin, with bevacizumab continued in 3-week cycles. arm 2: Participants will receive bevacizumab plus FOLFIRI by IV infusion on Day 1 of each 2-week cycle until disease progression or unacceptable toxicity. Participants may be transitioned to oral capecitabine in the event of unacceptable toxicity to irinotecan, with bevacizumab continued in 3-week cycles.

Interventions: intervention 1: 5-Fluorouracil intervention 2: Bevacizumab intervention 3: Irinotecan intervention 4: Leucovorin intervention 5: Oxaliplatin intervention 6: Capecitabine
Intervention descriptions: intervention 1: 5-Fluorouracil 400 milligrams per meter-squared (mg/m\^2) by IV bolus and subsequent 2400 mg/m\^2 by IV infusion over 46 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 2: Bevacizumab 5 milligrams per kilogram (mg/kg) of body weight via IV infusion will be administered every 2 weeks until disease progression or unacceptable toxicity. If participants are discontinued from oxaliplatin or irinotecan due to unacceptable toxicity, bevacizumab may be given in 3-week cycles with capecitabine. intervention 3: Irinotecan 180 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 4: Leucovorin 400 mg/m\^2 or dose deemed appropriate by Investigator via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 5: Oxaliplatin 85 mg/m\^2 via IV infusion over 2 hours will be administered every 2 weeks until disease progression or unacceptable toxicity. intervention 6: Capecitabine 850 or 1000 mg/m\^2 may be offered in the event of unacceptable toxicity to oxaliplatin or irinotecan, to be given orally twice a day on Days 1 to 14 in 3-week cycles.

Protocol document: