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Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

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ClinicalTrials.gov Identifier: NCT00324610
Recruitment Status : Unknown
Verified May 2006 by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie.
Recruitment status was:  Recruiting
First Posted : May 11, 2006
Last Update Posted : May 18, 2006
Sponsor:
Information provided by:
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


Condition or disease Intervention/treatment Phase
Breast Neoplasms Chemotherapy Drug: capecitabine Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 46 participants
Official Title: Phase I/II Study of Tolerance and Pharmacokinetics With Capecitabine Given 5 Days Out of 7 in Metastatic Breast Cancer
Study Start Date : March 2006

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00324610


Contacts
Contact: eric levy, md 33-1-56092985 eric.levy@egp.aphp.fr
Contact: kahina rideller, CRA 33-1-56093433 kahina.rideller@egp.aphp.fr

Locations
France
Ho¨Pital Europeen Georges Pompidou Recruiting
Paris, France, 75015
Contact: ERIC LEVY, MD    33-1-56092985    eric.levy@egp.aphp.fr   
Sub-Investigator: jacques medioni, MD         
Sponsors and Collaborators
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Investigators
Principal Investigator: eric levy, MD HEGP , PARIS
Study Chair: joseph Gligorov, MD HOPITAL 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

ClinicalTrials.gov Identifier: NCT00324610     History of Changes
Other Study ID Numbers: CAP 5/7
ARTIC / CAP 5/7
First Posted: May 11, 2006    Key Record Dates
Last Update Posted: May 18, 2006
Last Verified: May 2006

Keywords provided by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie:
fluoropyrimidines
metastases
pharmacokinetics
phase 1-2 study

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Capecitabine
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents