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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase II, Double Blind, Placebo Controlled, Randomised Study 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

Conditions
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Colorectal Cancer

Intervention / Treatment
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* Drug: Vandetanib
* Drug: FOLFIRI


Participation Criteria
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Eligibility Criteria
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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.

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>FOLFIRI + placebo vandetanib | Drug: FOLFIRI<br>* Intravenous infusion<br>|
| Experimental: 2<br>FOLFIRI + low dose vandetanib | Drug: Vandetanib<br>* once daily oral tablet two doses<br>* Other names: ZACTIMA™;Drug: FOLFIRI<br>* Intravenous infusion<br>|
| Experimental: 3<br>FOLFIRI + high dose vandetanib | Drug: Vandetanib<br>* once daily oral tablet two doses<br>* Other names: ZACTIMA™;Drug: FOLFIRI<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) | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Colon Cancer, Rectal Cancer