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
- Registration Number
- NCT00454116
- Lead Sponsor
- Genzyme, a Sanofi Company
- 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 failed therapy with an oxaliplatin and fluoropyrimidine containing regimen.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
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
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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.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 FOLFIRI FOLFIRI + placebo vandetanib 2 FOLFIRI FOLFIRI + low dose vandetanib 3 FOLFIRI FOLFIRI + high dose vandetanib 2 Vandetanib FOLFIRI + low dose vandetanib 3 Vandetanib FOLFIRI + high dose vandetanib
- Primary Outcome Measures
Name Time Method Number of Patients With an Objective Disease Progression Event Tumour assessments carried out at screening and then as per site clinical practice until objective progression. The only additional mandatory tumour assessment visit is at the point of data cut-off (28 March 2008 +/-3 days) Number of patients with objective disease progression or death (by any cause in the absence of objective progression)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Research Site
🇬🇧Manchester, United Kingdom
Research site
🇬🇧Belfast, Northern Ireland, United Kingdom