Status:
COMPLETED
Phase II Study of Simvastatin Plus Irinotecan, Fluorouracil, and Leucovorin(FOLFIRI) for Metastatic CRC
Lead Sponsor:
Samsung Medical Center
Conditions:
Colorectal Cancer
Metastasis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
This trial is designed to assess the tolerability and efficacy of simvastatin plus FOLFIRI (irinotecan, 5-FU, leucovorin) in metastatic colorectal cancer patients.
Detailed Description
Progress in treatment for metastatic CRC has undoubtedly been achieved in the past decade. Until 1985, 5-fluorouracil (5-FU) was the only agent available for the treatment of metastatic CRC. Several t...
Eligibility Criteria
Inclusion
- Histologically or cytologically confirmed metastatic colorectal cancer
- Age ≥ 18
- ECOG performance status 0 - 2
- At least one measurable lesion
- Minimum life expectancy of 12 weeks
- Adequate bone marrow reservoir (ANC ≥ 1500/㎕, platelet ≥ 100,000/㎕)
- Adequate renal function (serum creatinine ≤ 1.5 mg/dl or creatinine clearance ≥ 50 min/ml)
- Adequate liver functions (serum bilirubin ≤ 1.5 mg/dl, AST/ALT ≤ 3 times upper normal limits)
- No prior lipid-lowering therapy with statins less than 1 year before study entry
- No prior chemo- or immunotherapy for metastatic CRC (adjuvant chemotherapy or chemoradiation therapy more than 6 months before study entry is permitted)
- Written informed consent
Exclusion
- Active infection requiring antibiotics therapy
- Pregnancy and/or lactation
- Other serious illness or medical condition not appropriate for chemotherapy, especially cardiovascular disease
- Metastatic brain lesions
- Receipt of radiotherapy within 2 weeks before the initiation of study treatment
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2007
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT00313859
Start Date
September 1 2005
End Date
August 1 2007
Last Update
February 2 2012
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea