Study Of Sunitinib With FOLFIRI In Colorectal Cancer
- Sponsor
- Pfizer
- Study ID
- NCT00668863
- Phase
- PHASE2
- Status
- Completed
Conditions
- Unresectable or Metastatic Colorectal Cancer
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- FOLFIRI (The combination regimen of Irinotecan, l-Leucovorin and 5-Fluorouracil) — DRUGFOLFIRI treatment with Sunitinib on Day, Irinotecan 180M/M IV , l-Leucovorin 200M/M, 5FU 400M/M bolus and 2400M/M in 46-hour continuous infusion on Day1 each 42 day cycle. Number of Cycles: until progression or unacceptable toxicity develops.
- Sunitinib — DRUG37.5mg daily P.O., 4 weeks On 2weeks Off each 42 day cycle. Number of cycles: until progression or unacceptable toxicity develops.
Study Details
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
Key Dates
- Start date
- May 31, 2008
- Status verified
- Oct 2011
- Primary completion
- Sep 30, 2010
- Completion
- Sep 30, 2010
Study Design
- Enrollment
- 71 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: 1
Primary Outcome Measure
Progression-Free Survival (PFS) [ Time Frame: Up to 11 cycles (1 cycle = 6 weeks) ]