Status:
COMPLETED
Study Of FOLFIRI Chemotherapy With Or Without Sunitinib In Patients With Metastatic Colorectal Cancer
Lead Sponsor:
Pfizer
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of the study is to evaluate the safety and efficacy of FOLFIRI (Irinotecan, Leucovorin and 5 Fluorouracil) chemotherapy when combined with sunitinib or FOLFIRI chemotherapy without adding ...
Detailed Description
On June 25, 2009, the independent Data Monitoring Committee (DMC) reviewed the progress of Study A6181122. The DMC determined Study A6181122 had met pre-specified futility criteria and was unlikely to...
Eligibility Criteria
Inclusion
- Confirmed (histologically or cytologically) colorectal adenocarcinoma with metastatic disease.
- Not received previous therapy for metastatic colorectal disease but for whom FOLFIRI treatment is clinically indicated.
- Adequate organ function defined by blood test.
Exclusion
- History of another primary cancer in the last 3 years.
- Previous full field radiotherapy within the last 4 weeks or limited field radiotherapy within 2 weeks of enrolling into the study. Or previous radiation treatment of more that 30% of the bone marrow.
- History of presence of brain metastasis, spinal cord compression carcinomatous meningitis or leptomeningeal disease.
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
768 Patients enrolled
Trial Details
Trial ID
NCT00457691
Start Date
June 1 2007
End Date
March 1 2010
Last Update
March 30 2015
Active Locations (132)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
La Plata, Buenos Aires, Argentina, B1902AVQ
2
Pfizer Investigational Site
Santa Fe, Santa Fe Province, Argentina, S3000FFU
3
Pfizer Investigational Site
Wollongong, New South Wales, Australia, 2500
4
Pfizer Investigational Site
East Bentleigh, Victoria, Australia, 3165