Status:
UNKNOWN
Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
Lead Sponsor:
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Conditions:
Breast Neoplasms
Chemotherapy
Eligibility:
FEMALE
18+ years
Phase:
PHASE1
PHASE2
Brief 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 pharm...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 1 2006
Trial Type :
INTERVENTIONAL
End Date :
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00324610
Start Date
March 1 2006
Last Update
May 18 2006
Active Locations (1)
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1
Ho¨Pital Europeen Georges Pompidou
Paris, France, 75015