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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00500292
• Other study ID #: D4200C00047
• Secondary ID: 2006-005022-23LP
• Status: Completed
• Phase: Phase 2
• First received: July 3, 2007
• Last updated: January 24, 2018
• Start date: March 2007
• Est. completion date: November 2016

Study information

• Verified date: January 2018
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 2016
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Colorectal
• Colorectal Neoplasms

Intervention

Drug:
• Vandetanib
once daily oral tablet two dose strengths
• FOLFOX regimen=oxaliplatin, fluorouracil, & folinic acid
intravenous infusion

Locations

Country	Name	City	State
France	Research Site	Lille Cedex
France	Research Site	Toulouse Cedex 9
Hungary	Research Site	Budapest
Hungary	Research Site	Debrecen
Hungary	Research Site	Szeged
Korea, Republic of	Research Site	Seoul
Slovakia	Research Site	Bratislava
Slovakia	Research Site	Poprad
Slovakia	Research Site	Trnava
Slovakia	Research Site	Zilina
Spain	Research Site	Hospitalet deLlobregat
Spain	Research Site	Oviedo
Spain	Research Site	Santander
Taiwan	Research Site	Taipei
Taiwan	Research Site	Tao-Yuan

Sponsors (1)

Lead Sponsor	Collaborator
Genzyme, a Sanofi Company

Countries where clinical trial is conducted

France,  Hungary,  Korea, Republic of,  Slovakia,  Spain,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	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)

External Links

•   Link
•   CSR-D4200C00047.pdf