Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Phase 1

• Conditions: Breast Neoplasms; Chemotherapy

• Registration Number: NCT00324610
• Lead Sponsor: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

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 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

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Status Verified: 2006-05
• Study First Submitted: 2006-05-09
• Study First Submitted QC: 2006-05-09
• Study First Posted: 2006-05-11
• Last Update Submitted: 2006-05-16
• Last Update Posted: 2006-05-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Ho¨Pital Europeen Georges Pompidou; 🇫🇷 Paris, France