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

Genzyme, a Sanofi Company106 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

106

Conditions

Colorectal Cancer

Interventions

VandetanibDRUG

once daily oral tablet two doses

FOLFIRIDRUG

Intravenous infusion

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (21)

Research Site

Ann Arbor, Michigan, United States

Research Site

New York, New York, United States

Outcomes

Primary Outcomes

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)

Time frame: 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)

Data from ClinicalTrials.gov

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