Overview

Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Status:
Unknown status
Trial end date:
1969-12-31
Target enrollment:
0
Participant gender:
Female
Summary
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
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Treatments:
Capecitabine
Criteria
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