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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


Phase 4
18 Years
85 Years
Not Enrolling
Both
Metastatic Colorectal Cancer

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

tumor response rate

Outcome Time Frame:

during the treatment

Safety Issue:

No

Principal Investigator

Gilles Freyer, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Department of Oncology, CHLS, 69310 Pierre Benite, France

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

COLOGEN

NCT ID:

NCT00138060

Start Date:

June 2005

Completion Date:

December 2008

Related Keywords:

  • Metastatic Colorectal Cancer
  • genotypic profile
  • metastatic colorectal cancer
  • Colorectal Neoplasms

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