Title
Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
Phase
Phase 1/Phase 2Study Type
InterventionalStatus
Unknown statusIndication/Condition
Breast Neoplasms ChemotherapyIntervention/Treatment
capecitabine ...Study Participants
46Standard 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
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
