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NCT00454116 Clinical Trial

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

Colorectal Cancer Clinical Trial

Official title:
A Phase II, Double Blind, Placebo Controlled, Randomised Study 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 Anoxaliplatin and Fluoropyrimidine Containing Regimen

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00454116
Other study ID # D4200C00048
Secondary ID
Status Completed
Phase Phase 2
First received March 28, 2007
Last updated April 27, 2011
Start date March 2007
Est. completion date November 2009

Study information
Verified date April 2011
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date November 2009
Est. primary completion date March 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Vandetanib
once daily oral tablet two doses
• FOLFIRI
Intravenous infusion

Locations
Country Name City State
Argentina Research Site Buenos Aires
Argentina Research Site Ramos Mejia
Argentina Research Site Rosario
Argentina Research Site Santa Fe
Argentina Research Site Vicente Lopez
Korea, Republic of Research Site Seoul
Norway Research Site Bergen
Norway Research Site Oslo
Norway Research Site Stavanger
Spain Research Site A Coruna
Spain Research Site Barcelona
Spain Research Site Jaen
Spain Research Site Lerida
Spain Research Site Lleida
United Kingdom Research Site Aberdeen
United Kingdom Research site Belfast Northern Ireland
United Kingdom Research Site Leicester
United Kingdom Research Site Manchester
United States Research Site Ann Arbor Michigan
United States Research Site Nashville Tennessee
United States Research Site New York New York
United States Research Site Salt Lake City Utah

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Argentina,  Korea, Republic of,  Norway,  Spain,  United Kingdom, 

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) 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) No
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