Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer

• Drug: 5 fluorouracil
  400mg/m2 bolus injection day 1 followed by 2400mg/m2 continuous infusion for 46 hours every 14 days
• Drug: irinotecan
  180mg/m2 iv day 1 every 14 days
• Drug: levo- leucovorin
  200mg/m2 iv; day 1 every 14 days
• Drug: sunitinib
  37.5mg of blinded therapy every day for 28 days followed by 14 days of blinded therapy free period
• Drug: placebo
  37.5mg of blinded placebo therapy every day for 28 days followed by 14 days of blinded therapy free period

• Experimental: 1
  Interventions:

  • Drug: 5 fluorouracil
  • Drug: irinotecan
  • Drug: levo- leucovorin
  • Drug: sunitinib
• Placebo Comparator: 2
  Interventions:

  • Drug: 5 fluorouracil
  • Drug: irinotecan
  • Drug: levo- leucovorin
  • Drug: placebo

Inclusion Criteria:

• Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
• Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
• Adequate organ function defined by blood test.

Exclusion Criteria:

• History of another primary cancer in the last 3 years.
• Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
• History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.