Conditions: Metastatic Colorectal Cancer
Keywords: Oncology Cancer Metastatic Colorectal Cancer EGFr Panitumumab Clinical Trial Amgen
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 1186
Healthy volunteers: no

Brief summary:
The purpose of this study is to evaluate the treatment effect of panitumumab plus FOLFIRI compared to FOLFIRI alone as second line therapy for metastatic colorectal cancer.

Detailed description:

Arms:
arm 1: Participants received panitumumab as an intravenous (IV) infusion at a dose of 6 mg/kg plus a standard chemotherapy regimen (FOLFIRI) consisting of 5-fluorouracil (5-FU), leucovorin and irinotecan. Treatment was administered in cycles every two weeks. arm 2: Participants received standard chemotherapy regimen (FOLFIRI) consisting of 5-FU, leucovorin and irinotecan. Treatment is administered in cycles every two weeks.

Interventions: intervention 1: Panitumumab intervention 2: FOLFIRI
Intervention descriptions: intervention 1: Panitumumab was administered by IV infusion on Day 1 of each 14-day cycle, just before administration of FOLFIRI chemotherapy. intervention 2: FOLFIRI chemotherapy was initiated on Day 1 of each treatment cycle at the following starting doses: irinotecan 180 mg/m\^2, leucovorin 400 mg/m\^2 racemate (or 200 mg/m\^2 I-leucovorin), 5-FU bolus 400 mg/m\^2, 5-FU infusion 2400 mg/m\^2.

Protocol document: