Status:
TERMINATED
Randomized Study Of Sunitinib Plus FOLFOX Versus Bevacizumab Plus FOLFOX In Metastatic Colorectal Cancer
Lead Sponsor:
Pfizer
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This study will compare the safety and efficacy of sunitinib in combination with FOLFOX versus bevacizumab in combination with FOLFOX for the treatment of patients with metastatic colorectal cancer wh...
Detailed Description
The study was terminated on April 26, 2010 due to lack of efficacy, as determined during the interim analysis of data in April 2010, showing that the study did not meet its primary endpoint to demonst...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the colon or rectum with locally advanced or metastatic disease
- Evidence of measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST)
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
Exclusion
- Previous treatment with Sutent, Avastin, or any other systemic therapy for locally advanced or metastatic colorectal cancer
- Less than 6 months since completion of adjuvant chemotherapy to documentation of recurrent disease
- History of cardiac disease
- Brain mets
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2011
Estimated Enrollment :
191 Patients enrolled
Trial Details
Trial ID
NCT00609622
Start Date
April 1 2008
End Date
July 1 2011
Last Update
October 11 2012
Active Locations (97)
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1
Pfizer Investigational Site
Fairhope, Alabama, United States, 36532
2
Pfizer Investigational Site
Mobile, Alabama, United States, 36604
3
Pfizer Investigational Site
Chandler, Arizona, United States, 85224
4
Pfizer Investigational Site
Mesa, Arizona, United States, 85206