Clinical trial NCT00454116: 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
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 an Oxaliplatin and Fluoropyrimidine Containing Regimen
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Colorectal Cancer
Keywords: Colon Cancer
Rectal Cancer
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2007-03-30
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of Patients With an Objective Disease Progression Event
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: Research Site
state: Michigan
city: New York
country: United States
facility: Research Site
state: New York
city: Nashville
country: United States
facility: Research Site
state: Tennessee
city: Salt Lake City
country: United States
facility: Research Site
state: Utah
city: Buenos Aires
country: Argentina
facility: Research Site
city: Ramos Mejia
country: Argentina
facility: Research Site
city: Rosario
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Vicente Lopez
country: Argentina
facility: Research Site
city: Seoul
country: Korea, Republic of
facility: Research Site
city: Bergen
country: Norway
facility: Research Site
city: Oslo
country: Norway
facility: Research Site
city: Stavanger
country: Norway
facility: Research Site
city: A Coruna
country: Spain
facility: Research Site
city: Barcelona
country: Spain
facility: Research Site
city: Jaen
country: Spain
facility: Research Site
city: Lerida
country: Spain
facility: Research Site
city: Lleida
country: Spain
facility: Research Site
city: Belfast
country: United Kingdom
facility: Research site
state: Northern Ireland
city: Aberdeen
country: United Kingdom
facility: Research Site
city: Leicester
country: United Kingdom
facility: Research Site
city: Manchester
country: United Kingdom
facility: Research Site
Study officials:
affiliation: Sanofi
name: Clinical Sciences & Operations
role: STUDY_DIRECTOR
References: