Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie46 enrolled

Overview

Standard administration of capecitabine use a 14 days administration. Routine practice in several intitution leads to use a 5 out of 7 days regimen, with less toxicity. Purpose : to compare the pharmacokinetics of capecitabine, administered 5 days out of 7, as compared to the standard administration (14 days out of 21). The second end point is to compare toxicity with either regimen. Method : Randomized study with two groups : one with standard administration , the second with 5/7 days regimen

Study Type

INTERVENTIONAL

Enrollment

Conditions

Breast Neoplasms Chemotherapy

Interventions

capecitabineDRUG

Eligibility

Sex: FEMALEMin age: 18 Years

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Inclusion Criteria: * Histologically proven breast adenocarcinoma * Evaluable or measurable metastases * HER-2 status 0 or 1 in immnohistochimy or negative in FISH/CISH * Previously treated with anthracyclines and taxanes * Age \> = 18 y * No more than two previous chemotherapy regimens for metastases * No nervous central system involvement * Hormonal therapy must have been stopped two weeks before enrollment * Adequate biologic function * Performance status OMS \< = 2 * Signed informed consent Exclusion Criteria: * History of other malignancies, except basocellular cancer, in situ cervix carcinoma * Gastro intestinal disease that might affect absorption of capecitabine * Cardiac failure or angina pectoris uncontrolled * Hypersensitivity for capecitabine, fluorouracil, or one of their excipient * Known dihydropyrimidine dehydrogenase (DPD) deficiency * Concomitant anticancer therapy (included hormonotherapy) * Concomitant radiotherapy * Treatment with sorivudine and analogs * Pregnant or breast feeding patients. Contraception methods excluding hormonal treatment is required. * Inclusion in an experimental protocol within 30 days

Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Overview

Conditions

Interventions

Eligibility

Locations (1)

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