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

Phase 4

Completed

• Conditions: Metastatic Colorectal Cancer

• Registration Number: NCT00138060
• Lead Sponsor: Institut de Recherche Clinique sur les Cancers et le Sang

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-06
• Study First Submitted: 2005-08-26
• Study First Submitted QC: 2005-08-26
• Study First Posted: 2005-08-30
• Primary Completion: 2008-11
• Study Completion: 2008-12
• Status Verified: 2010-07
• Last Update Submitted: 2010-07-19
• Last Update Posted: 2010-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 71

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
tumor response rate	during the treatment

Secondary Outcome Measures

Name	Time	Method
toxicity	during the treatment
pharmacokinetics	during the first administration

Trial Locations

Locations (6)

Department of Oncology - CHLS; 🇫🇷 Pierre Benite, France

Department of Gastroenterology, CHLS; 🇫🇷 Pierre Benite, France

Department of Oncology, CHU; 🇫🇷 Grenoble, France

Department of Oncology, ICL; 🇫🇷 Saint-Priest-en-Jarez, France

Institut Claudius Regaud; 🇫🇷 Toulouse, France

Department of Oncology, IPC; 🇫🇷 Grenoble, France