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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00138060 |
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Date of registration:
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26/08/2005 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Toxicity/Benefit Ratio Optimization of Chemotherapy in Colorectal Cancer (CRC) Patients by Determination of Individual Genotypic Determinants
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Scientific title:
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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 |
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Date of first enrolment:
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June 2005 |
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Target sample size:
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71 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00138060 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 4
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Countries of recruitment
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France
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Contacts
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Name:
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Gilles Freyer, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Oncology, CHLS, 69310 Pierre Benite, France |
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Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
85 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Metastatic Colorectal Cancer
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Intervention(s)
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Drug: 5 fluorouracil
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Drug: irinotecan
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Primary Outcome(s)
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tumor response rate
[Time Frame: during the treatment]
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Secondary Outcome(s)
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toxicity
[Time Frame: during the treatment]
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pharmacokinetics
[Time Frame: during the first administration]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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