Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants

• Status: Completed
• Trial end date: 2008-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study intends to optimize a fluorouracil/irinotecan chemotherapy regimen by the identification of individual thymidylate synthase (TS) and UDP-glucuronosyltransferase 1 (UGT1A1) polymorphisms before the first administration.

The results of this identification determine the chemotherapy type: high-dose irinotecan or not.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institut de Recherche Clinique sur les Cancers et le Sang
• Collaborator: Pfizer
• Treatments: Fluorouracil; Irinotecan

Criteria

Inclusion Criteria:

• Has provided written informed consent prior to study-specific screening procedures, with the understanding that the patient has the right to withdraw from the study at any time without prejudice

• Ages between 18 and 85 years

• Histologically confirmed colorectal cancer

• No treatment for metastatic disease

• No irinotecan previously administered

• World Health Organization (WHO) performance status < 3

• Laboratory values :

• neutrophils > 1.5 x 10^9/L;

• platelet count > 100 x 10^9/L;

• serum creatinine < 130µmol/L;

• serum bilirubin < 2 x upper limit of normal (ULN);

• ASAT and ALAT < 2.5 x ULN;

• alkaline phosphatase < 5 x ULN.

• At least one measurable lesion by Response Evaluation Criteria in Solid Tumors (RECIST) criteria

Exclusion Criteria:

• History of another malignancy except cured basal cell carcinoma of the skin or carcinoma in situ of the uterine cervix, breast or bladder.

• Other concomitant anticancer therapy.

• Pregnant or lactating women.

• Women of childbearing potential unless using a reliable and appropriate contraceptive method.

• Symptomatic cerebral or leptospiral metastasis.

• Intestinal obstruction.

• Uncontrolled seizures (diabetes, severe infection).

• Clinically significant cardiac disease.

• Central nervous system disorders or severe psychiatric disability.

• Participation in any investigational study within 4 weeks.