Colorectal Cancer Clinical Trial
Official title:
Phase II Study of Simvastatin Plus Irinotecan, Fluorouracil, and Leucovorin(FOLFIRI) for Metastatic Colorectal Cancer
Verified date | January 2012 |
Source | Samsung Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Interventional |
This trial is designed to assess the tolerability and efficacy of simvastatin plus FOLFIRI (irinotecan, 5-FU, leucovorin) in metastatic colorectal cancer patients.
Status | Completed |
Enrollment | 50 |
Est. completion date | August 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Histologically or cytologically confirmed metastatic colorectal cancer 2. Age = 18 3. ECOG performance status 0 - 2 4. At least one measurable lesion 5. Minimum life expectancy of 12 weeks 6. Adequate bone marrow reservoir (ANC = 1500/?, platelet = 100,000/?) 7. Adequate renal function (serum creatinine = 1.5 mg/dl or creatinine clearance = 50 min/ml) 8. Adequate liver functions (serum bilirubin = 1.5 mg/dl, AST/ALT = 3 times upper normal limits) 9. No prior lipid-lowering therapy with statins less than 1 year before study entry 10. No prior chemo- or immunotherapy for metastatic CRC (adjuvant chemotherapy or chemoradiation therapy more than 6 months before study entry is permitted) 11. Written informed consent Exclusion Criteria: 1. Active infection requiring antibiotics therapy 2. Pregnancy and/or lactation 3. Other serious illness or medical condition not appropriate for chemotherapy, especially cardiovascular disease 4. Metastatic brain lesions 5. Receipt of radiotherapy within 2 weeks before the initiation of study treatment |
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Samsung Medical Center | Seoul |
Lead Sponsor | Collaborator |
---|---|
Samsung Medical Center |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | overall response rate | |||
Secondary | progression-free survival | |||
Secondary | overall survival | |||
Secondary | toxicity | |||
Secondary | duration of response |
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