Metastatic Colorectal Cancer
Conditions
Keywords
genotypic profile, metastatic colorectal cancer
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.
Interventions
DRUGirinotecan
180 mg/m² or 260 mg/m² in 90 minutes every 15 days
DRUG5 fluorouracil
400 mg/m² in bolus in day 1 and 2400 mg/m² in 46 hours perfusion
Sponsors
Pfizer
Institut de Recherche Clinique sur les Cancers et le Sang
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| tumor response rate | during the treatment |
Secondary
| Measure | Time frame |
|---|---|
| toxicity | during the treatment |
| pharmacokinetics | during the first administration |
Countries
France
Outcome results
None listed