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

Phase 2

Completed

• Conditions: Colorectal; Cancer
• Interventions: Drug: FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid; Drug: Vandetanib

• Registration Number: NCT00500292
• Lead Sponsor: Genzyme, a Sanofi Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-07-03
• Study First Submitted QC: 2007-07-11
• Study First Posted: 2007-07-12
• Primary Completion: 2008-03
• Results First Submitted: 2011-04-27
• Results First Submitted QC: 2011-04-27
• Results First Posted: 2011-05-24
• Study Completion: 2016-11
• Status Verified: 2018-01
• Last Update Submitted: 2018-01-24
• Last Update Posted: 2018-01-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid	FOLFOX + Placebo vandetanib
2	Vandetanib	FOLFOX + low dose vandetanib
2	FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid	FOLFOX + low dose vandetanib
3	Vandetanib	FOLFOX + high dose vandetanib
3	FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid	FOLFOX + high dose vandetanib

Primary Outcome Measures

Name	Time	Method
Number of Patients With an Objective Disease Progression Event	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)

Trial Locations

Locations (1)

Research Site; 🇨🇳 Tao-Yuan, Taiwan