Overview

This trial is active, not recruiting.

Conditions colorectal, cancer
Treatments vandetanib, folfox regimen=oxaliplatin, fluorouracil, & folinic acid
Phase phase 2
Target VEGF
Sponsor AstraZeneca
Start date March 2007
End date March 2008
Trial size 109 participants
Trial identifier NCT00500292, D4200C00047

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
FOLFOX + Placebo vandetanib
folfox regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
(Experimental)
FOLFOX + low dose vandetanib
vandetanib AZ6474
once daily oral tablet two dose strengths
folfox regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion
(Experimental)
FOLFOX + high dose vandetanib
vandetanib AZ6474
once daily oral tablet two dose strengths
folfox regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion

Primary Outcomes

Measure
Number of Patients With an Objective Disease Progression Event
time frame: 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)

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in April 2015.
Information provided to ClinicalTrials.gov by AstraZeneca.