Conditions: Colorectal Cancer
Keywords: second line metastatic colorectal cancer FOLFIRI ramucirumab CRC mCRC
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1072
Healthy volunteers: no

Brief summary:
The purpose of this study is to compare overall survival in participants with metastatic colorectal cancer treated with either ramucirumab and FOLFIRI or placebo and FOLFIRI.

Detailed description:

Arms:
arm 1: None arm 2: None

Interventions: intervention 1: Ramucirumab intervention 2: Placebo intervention 3: Irinotecan intervention 4: Folinic Acid intervention 5: 5-Fluorouracil
Intervention descriptions: intervention 1: 8 milligrams / kilogram (mg/kg) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 2: Administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 3: 180 milligrams/square meter (mg/m\^2) administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 4: 400 mg/m\^2 administered intravenously every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision intervention 5: 400 mg/m\^2 bolus immediately followed by 2400 mg/m\^2 continuous infusion every 2 weeks until disease progression, unacceptable toxicity, noncompliance or withdrawal of consent by the participant or investigator decision

Protocol document: