Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

May 16, 2006 updated by: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

46

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France, 75015
        • Recruiting
        • Ho¨Pital Europeen Georges Pompidou
        • Contact:
        • Sub-Investigator:
          • jacques medioni, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Investigators

  • Principal Investigator: eric levy, MD, HEGP , PARIS
  • Study Chair: joseph Gligorov, MD, Hôpital TENON, PARIS
  • Study Chair: Michèle TUBIANA HULIN, MD, CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE
  • Study Chair: VERONIQUE DIERAS, MD, INSTITUT CURIE, PARIS france
  • Study Chair: Rémi LARGILLIER, MD, Centre Antoine Lacassagne, Nice, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2006

Study Registration Dates

First Submitted

May 9, 2006

First Submitted That Met QC Criteria

May 9, 2006

First Posted (Estimate)

May 11, 2006

Study Record Updates

Last Update Posted (Estimate)

May 18, 2006

Last Update Submitted That Met QC Criteria

May 16, 2006

Last Verified

May 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAP 5/7
  • ARTIC / CAP 5/7

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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