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

• Status: Completed
• Trial end date: 2009-11-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Genzyme, a Sanofi Company

Criteria

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.