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

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.

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Key information

Conditions

Colorectal Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vandetanib

Drug

once daily oral tablet two dose strengths

Other names: AZ6474, ZACTIMA™, SAR390530

FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid

Drug

intravenous infusion

Primary outcomes

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)

Number of patients with objective disease progression or death (by any cause in the absence of objective progression)

Sponsors and collaborators

Lead sponsor

Genzyme, a Sanofi Company

Industry

Registry information

Official study 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

Important dates

Study start: 2007
Primary completion: 2008
Study completion: 2016
First posted: Jul 12, 2007
Registry last updated: Jan 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed