Status:
COMPLETED
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
Lead Sponsor:
Genzyme, a Sanofi Company
Conditions:
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2009
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT00454116
Start Date
March 1 2007
End Date
November 1 2009
Last Update
October 7 2016
Active Locations (21)
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1
Research Site
Ann Arbor, Michigan, United States
2
Research Site
New York, New York, United States
3
Research Site
Nashville, Tennessee, United States
4
Research Site
Salt Lake City, Utah, United States