Status:
COMPLETED
Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Lead Sponsor:
Institut de Recherche Clinique sur les Cancers et le Sang
Collaborating Sponsors:
Pfizer
Conditions:
Metastatic Colorectal Cancer
Eligibility:
All Genders
18-85 years
Phase:
PHASE4
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 bef...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
71 Patients enrolled
Trial Details
Trial ID
NCT00138060
Start Date
June 1 2005
End Date
December 1 2008
Last Update
July 20 2010
Active Locations (6)
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1
Department of Oncology, CHU
Grenoble, France, 38043
2
Department of Oncology, IPC
Grenoble, France, 38100
3
Department of Gastroenterology, CHLS
Pierre-Bénite, France, 69310
4
Department of Oncology - CHLS
Pierre-Bénite, France, 69310