Conditions: Colon Cancer Rectal Cancer
Keywords: Colonic Neoplasms Rectal Neoplasms Adenocarcinoma Antibodies, Monoclonal
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 158
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine if participants with metastatic colorectal cancer live longer without their cancer progressing when treated with standard chemotherapy, standard chemotherapy plus ramucirumab, or standard chemotherapy plus icrucumab.

Detailed description:
The purpose of this study is to evaluate the progression-free survival (PFS) in participants with metastatic colorectal cancer when treated with 1 of 3 modified FOLFOX-6 (folinic acid \[FA\] + fluorouracil \[5-FU\] + oxaliplatin \[mFOLFOX-6\])-based regimens, as second-line therapy.

During 2010, there has been an identified shortage of injectable folinic acid (FA) in the United States. Levo-folinic acid (LFA) will be allowed as a substitute for FA in the mFOLFOX-6 chemotherapy regimen in circumstances in which FA is not available, to facilitate continuity of participant care.

Arms:
arm 1: mFOLFOX-6 arm 2: mFOLFOX-6 + Ramucirumab arm 3: mFOLFOX-6 + Icrucumab

Interventions: intervention 1: Ramucirumab intervention 2: Icrucumab intervention 3: mFOLFOX-6
Intervention descriptions: intervention 1: 8 mg/kg IV Q2W intervention 2: 15 mg/kg IV Q2W intervention 3: Oxaliplatin: 85 milligram per square meter (mg/m²) IV every 2 weeks (Q2W)

FA: 400 mg/m² IV Q2W (or LFA: 200 mg/m² Q2W if FA is unavailable).

5FU: 400 mg/m² bolus + 2400 mg/m² IV Q2W

Protocol document: