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

Completed · Phase 2

Conditions studied: Colorectal Cancer

In brief

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.

Key facts

Study ID

NCT00454116

Run by

Genzyme, a Sanofi Company

People needed

106

Starts

2007-03-01

Expected to finish

2009-11-01

Last updated by the study team

2016-10-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Research Site — Ann Arbor, Michigan, United States
• Research Site — New York, New York, United States
• Research Site — Nashville, Tennessee, United States
• Research Site — Salt Lake City, Utah, United States
• Research Site — Buenos Aires, Argentina
• Research Site — Ramos Mejía, Argentina
• Research Site — Rosario, Argentina
• Research Site — Santa Fe, Argentina
• Research Site — Vicente López, Argentina
• Research Site — Bergen, Norway
• Research Site — Oslo, Norway
• Research Site — Stavanger, Norway
• Research Site — Seoul, South Korea
• Research Site — A Coruña, Spain
• Research Site — Barcelona, Spain
• Research Site — Jaén, Spain
• Research Site — Lleida, Spain
• Research site — Belfast, Northern Ireland, United Kingdom
• Research Site — Aberdeen, United Kingdom
• Research Site — Leicester, United Kingdom
• Research Site — Manchester, United Kingdom

Full record on ClinicalTrials.gov

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