Status:
COMPLETED
Study Of Sunitinib In Combination With Folfox In Patients With Colorectal Cancer
Lead Sponsor:
Pfizer
Conditions:
Colorectal Neoplasms
Eligibility:
All Genders
20+ years
Phase:
PHASE1
Brief Summary
To assess the safety and tolerability of sunitinib when administered in combination with modified FOLFOX6 in Japanese patients with metastatic colorectal cancer in the first-line treatment setting.
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed adenocarcinoma of the colon or rectum with documented locally advanced or metastatic disease.
- Evidence of unidimensionally measurable disease as defined by the Response Evaluation Criteria in Solid Tumors (RECIST).
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Exclusion
- Prior treatment with systemic therapy for locally advanced or metastatic colorectal cancer.
- Prior surgery or investigational agent within 4 weeks prior to study entry.
- Pregnancy or breastfeeding. All female patients of reproductive potential must have a negative pregnancy test (serum or urine) prior to the start of the study.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2010
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00631410
Start Date
January 1 2008
End Date
March 1 2010
Last Update
March 16 2011
Active Locations (3)
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1
Pfizer Investigational Site
Kashiwa, Chiba, Japan
2
Pfizer Investigational Site
Suntougun, Shizuoka, Japan
3
Pfizer Investigational Site
Chuo-ku, Tokyo, Japan