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

Institut de Recherche Clinique sur les Cancers et le Sang

Status and phase: Completed; Phase 4

Conditions: Metastatic Colorectal Cancer

Treatments: Drug: irinotecan; Drug: 5 fluorouracil

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00138060

COLOGEN

Details and patient eligibility

About

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.

Enrollment: 71 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)