Trial Information
Phase I Study Of Sunitinib In Combination With Oxaliplatin, L-Leucovorin, And 5-Fluorouracil In Patients With Metastatic Colorectal Cancer
Inclusion Criteria:
- 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 Criteria:
- 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.
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Number of Participants With Adverse Events
Outcome Description:
Number of participants with any adverse events, adverse events graded as Common Terminology Criteria for Adverse Events Version 3.0 (CTCAE) Grade 3 or higher , serious adverse events, adverse events resulted in discontinuation, treatment interruption, or dose reduction.
Outcome Time Frame:
Up to 733 days (the last subject study discontinuation)
Safety Issue:
Yes
Principal Investigator
Pfizer CT.gov Call Center
Investigator Role:
Study Director
Investigator Affiliation:
Pfizer
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
A6181148
NCT ID:
NCT00631410
Start Date:
January 2008
Completion Date:
March 2010
Related Keywords:
- Colorectal Neoplasms
- Phase 1
- CRC
- SU011248
- Sunitinib
- FOLFOX
- Colorectal cancer
- metastatic carcinoma of the colon or rectum
- Neoplasms
- Colorectal Neoplasms