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

Sponsor

Institut de Recherche Clinique sur les Cancers et le Sang (Other)

Overall Status

Completed

CT.gov ID

NCT00138060

Collaborator

Pfizer (Industry)

Enrollment

Locations

Duration (Months)

11.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Metastatic Colorectal Cancer	Drug: irinotecan Drug: 5 fluorouracil	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

71 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Jun 1, 2005

Actual Primary Completion Date :

Nov 1, 2008

Actual Study Completion Date :

Dec 1, 2008

Outcome Measures

Primary Outcome Measures

tumor response rate [during the treatment]

Secondary Outcome Measures

toxicity [during the treatment]
pharmacokinetics [during the first administration]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Department of Oncology, CHU	Grenoble	France	38043
2	Department of Oncology, IPC	Grenoble	France	38100
3	Department of Gastroenterology, CHLS	Pierre Benite	France	69310
4	Department of Oncology - CHLS	Pierre Benite	France	69310
5	Department of Oncology, ICL	Saint-Priest-en-Jarez	France	42271
6	Institut Claudius Regaud	Toulouse	France