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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

71 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-06-30

Study Completion Date

2008-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Metastatic Colorectal Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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irinotecan

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

Intervention Type DRUG

5 fluorouracil

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

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No