A Phase II Study of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer

A Phase II, Double-blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of 2 Doses of ZD6474 (Vandetanib) in Combination With FOLFOX vs FOLFOX Alone for the Treatment of Colorectal Cancer in Patients Who Have Failed Therapy With an Irinotecan and Fluoropyrimidine Regimen

The purpose of this study is to determine whether treatment with ZACTIMA (vandetanib) in combination with FOLFOX is more effective than FOLFOX alone for colorectal cancer in patients who have failed therapy with an irinotecan and fluoropyrimidine containing regimen.

Inclusion Criteria:

• Progression on or following treatment for metastatic colorectal cancer
• Have failed therapy with an irinotecan and fluoropyrimidine containing regimen
• Have World Health Organisation (WHO) performance status 0-2 and life expectancy >12 weeks

Exclusion Criteria:

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