Status:
COMPLETED
Study Of Sunitinib With FOLFIRI In Colorectal Cancer
Lead Sponsor:
Pfizer
Conditions:
Unresectable or Metastatic Colorectal Cancer
Eligibility:
All Genders
20+ years
Phase:
PHASE2
Brief Summary
To evaluate the efficacy, safety and pharmacokinetics of sunitinib plus FOLFIRI (irinotecan, 5-FU and l-leucovorin) in the first-line treatment of Japanese mCRC patients
Eligibility Criteria
Inclusion
- Patient with histologically- or cytologically-confirmed colorectal adenocarcinoma with unresectable or metastatic disease documented on diagnostic imaging studies.
- Patient must have at least one RECIST-defined measurable lesion that has not been treated with prior local therapy.
Exclusion
- History of another primary malignancy within 3 years prior to study entry, with the exception of non-melanoma skin cancer and in situ carcinoma of the uterine cervix.
- Current, recent, or planned participation in an experimental treatment drug study other than this protocol.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2010
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00668863
Start Date
May 1 2008
End Date
September 1 2010
Last Update
October 17 2011
Active Locations (10)
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1
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan
2
Pfizer Investigational Site
Chiba, Chiba, Japan
3
Pfizer Investigational Site
Matsuyama, Ehime, Japan
4
Pfizer Investigational Site
Sapporo, Hokkaido, Japan