Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
Conditions
Breast Neoplasms - Chemotherapy
Conditions: official terms
Breast Neoplasms
Conditions: Keywords
fluoropyrimidines, metastases, pharmacokinetics, phase 1-2 study
Study Type
Interventional
Study Phase
Phase 1/Phase 2
Study Design
N/A
Intervention
Name: capecitabine
Type: Drug
Overall Status
Recruiting
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Female
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
Location
Ho¨Pital Europeen Georges Pompidou
Paris, France
Status: Recruiting
Contact: ERIC LEVY, MD - 33-1-56092985 - eric.levy@egp.aphp.fr
Start Date
March 2006
Sponsors
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Source
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page