Trial | NCT00138060  Report issue

Title

Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Protocole Evaluant Chez Des Patients Porteurs de Cancers Colorectaux Metastatiques l'Interet Des Determinants Genotypiques Pour l'Optimisation de l'Efficacite et de la Tolerance de la Chimiotherapie Par Irinotecan et 5-fluorouracile

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    71
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.
Study Started
Jun 30
2005
Primary Completion
Nov 30
2008
Study Completion
Dec 31
2008
Last Update
Jul 20
2010
Estimate

Drug irinotecan

180 mg/m² or 260 mg/m² in 90 minutes every 15 days

Drug 5 fluorouracil

400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion

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.
No Results Posted