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Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information
Basic Trial Information
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Age
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Protocol IDs
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Phase IV
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Diagnostic, Treatment
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Active
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18 to 85
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Other
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COLOGEN
NCT00138060
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Trial Description
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. Eligibility 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
- 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.
- 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.
Trial Contact Information
Trial Lead Organizations/Sponsors Institut de Recherches sur les Leucemies et les Maladies du Sang Pfizer Incorporated
| Gilles Freyer, MD | | Principal Investigator |
Trial Sites
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| France |
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Grenoble |
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| | | | | | | | CHU de Grenoble - Hopital de la Tronche |
| | | Christine Rebischung, MD | |
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Pierre-Benite |
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| | | Centre Hospitalier Lyon Sud |
| | | Gilles Freyer, MD |
Ph: 33478864318 |
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Email:
gilles.freyer@chu-lyon.fr |
| | | Veronique Trillet-lenoir, MD | Sub-Investigator |
| | | Magali Litor, MD | Sub-Investigator |
| | | Sophie Tartas, MD | Sub-Investigator |
| | | Nathalie Chavernoz, MD | Sub-Investigator |
| | | Bernard Flourie, MD | |
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Email:
bernard.flourie@chu-lyon.fr |
| | | Jean-Christophe Saurin, MD | Sub-Investigator |
| | | Olivier Glehen, MD | Sub-Investigator |
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Saint-Priest-en-Jarez |
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| | | Institut de Cancerologie de la Loire |
| | | Yacine Merrouche, MD | |
| | | Dominique Mille, MD | Sub-Investigator |
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Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00138060
Information obtained from ClinicalTrials.gov on May 27, 2008 Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain
the same text. Minor
changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and
contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should
be directed to ClinicalTrials.gov.
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