Conditions: Colorectal Cancer
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 84
Healthy volunteers: no

Brief summary:
The purpose of the study is to describe the tumor response rates for the two regimens being studied, and to determine how long patients live after receiving the treatment, how long patients are without return of their disease after they receive treatment, and how long the response they get from the treatment lasts. The amount and type of side effects/toxicities of each regimen will also be evaluated. The regimen including Oxaliplatin + 5FU/Folinic Acid is a current standard of care.

Detailed description:

Arms:
arm 1: Avastin + Gemcitabine + 5-Fluorouracil (5FU)/Folinic Acid arm 2: Avastin + Oxaliplatin + 5-Fluorouracil (5FU)/Folinic Acid

Interventions: intervention 1: Gemcitabine intervention 2: avastin intervention 3: 5FU/folinic acid intervention 4: oxaliplatin
Intervention descriptions: intervention 1: 900 mg/m2 IV over 90 minutes after Folinic Acid weekly for 6 weeks every 8 weeks until progression. intervention 2: 5 milligrams per kilogram (mg/kg) intervention 3: Folinic Acid: 100 milligrams per square meter (mg/m2) intravenous (IV) over 60 minutes (A+FFG).

Folinic Acid: 200 mg/m2 as a 2-hr infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4).

5-Fluorouracil: 450 mg/m2 as an IV bolus in middle of Folinic Acid (A+FFG). 5-Fluorouracil: 400 mg/m2 bolus plus a 600 mg/m2 22-hour infusion on Days 1 and 2 of a 14-day cycle (A+FOLFOX 4). intervention 4: 85 mg/m2 as a 2-hour infusion on Day 1 of a 14 day cycle.

Protocol document: