Informations générales (source: ClinicalTrials.gov)
Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
Interventional
Phase 1/Phase 2
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie (Voir sur ClinicalTrials)
mars 2006
29 juin 2024
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
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| EFS IDF SITE HOP EUROPEEN G POMPIDOU | ERIC LEVY, MD | Contact (sur clinicalTrials) | |||
Critères
Femme
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
- 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
- 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