A Phase II, Double Blind Study of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients

A Phase II, Double Blind, Placebo Controlled, Randomised Study to Assess the Efficacy and Safety of 2 Doses of ZACTIMA™(ZD6474) in Combination With FOLFIRI vs FOLFIRI Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Oxaliplatin and Fluoropyrimidine Containing Regimen

The purpose of this study is to assess the efficacy and safety of 2 doses of ZACTIMA™ (ZD6474) in combination with FOLFIRI vs FOLFIRI alone for the treatment of colorectal cancer in patients who have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.

Inclusion Criteria:

• Histologically confirmed colorectal cancer
• Have failed therapy with an oxaliplatin and fluoropyrimidine containing regimen defined as:
• Progression on or following treatment for metastatic colorectal cancer
• Progression within 12 months of adjuvant chemotherapy for colorectal cancer

Exclusion Criteria:

• Previous treatment with small molecule tyrosine kinase inhibitors of VEGFR or EGFR eg, erlotinib, gefitinib. Prior monoclonal antibodies are permitted, eg, cetuximab, bevacizumab.
• Previous adjuvant therapy with irinotecan within 12 months of randomization
• More than one prior course of chemotherapy for treatment of metastatic colorectal cancer.