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Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

NCT00324610 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2006-05-18

No results posted yet for this study

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

Conditions

  • Breast Neoplasms
  • Chemotherapy

Interventions

DRUG

capecitabine

Sponsors & Collaborators

  • Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

    lead OTHER

Principal Investigators

  • eric levy, MD · HEGP , PARIS

  • joseph Gligorov, MD · HOPITAL TENON, PARIS

  • Michèle TUBIANA HULIN, MD · CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE

  • VERONIQUE DIERAS, MD · INSTITUT CURIE, PARIS france

  • Rémi LARGILLIER, MD · centre antoine lacassagne, NICE, France

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2006-03-31

Countries

  • France

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00324610 on ClinicalTrials.gov