Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer

Status

UNKNOWN

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00324610

Enrollment

Registered

2006-05-11

Start date

2006-03-31

Completion date

Unknown

Last updated

2006-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Chemotherapy

Keywords

fluoropyrimidines, metastases, pharmacokinetics, phase 1-2 study

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

Interventions

DRUGcapecitabine

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Countries

France

Contacts

Primary Contacteric levy, md

eric.levy@egp.aphp.fr33-1-56092985

Backup Contactkahina rideller, CRA

kahina.rideller@egp.aphp.fr33-1-56093433

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026