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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Colorectal, Cancer

Intervention / Treatment
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* Drug: Vandetanib
* Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>FOLFOX + Placebo vandetanib | Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid<br>* intravenous infusion<br>|
| Experimental: 2<br>FOLFOX + low dose vandetanib | Drug: Vandetanib<br>* once daily oral tablet two dose strengths<br>* Other names: SAR390530;Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid<br>* intravenous infusion<br>|
| Experimental: 3<br>FOLFOX + high dose vandetanib | Drug: Vandetanib<br>* once daily oral tablet two dose strengths<br>* Other names: SAR390530;Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid<br>* intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With an Objective Disease Progression Event | Number of patients with objective disease progression or death (by any cause in the absence of objective progression) | RECIST 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 (5 March 2008 +/-3 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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colorectal, cancer, zactima