Phase II Study of Simvastatin Plus Irinotecan, Fluorouracil, and Leucovorin(FOLFIRI) for Metastatic CRC

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

This trial is designed to assess the tolerability and efficacy of simvastatin plus FOLFIRI (irinotecan, 5-FU, leucovorin) in metastatic colorectal cancer patients.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Samsung Medical Center
• Treatments: Fluorouracil; Irinotecan; Simvastatin

Criteria

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