Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
ClinicalTrials.gov Identifier:
NCT00324610
First received: May 9, 2006
Last updated: May 16, 2006
Last verified: May 2006

May 9, 2006
May 16, 2006
March 2006
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Complete list of historical versions of study NCT00324610 on ClinicalTrials.gov Archive Site
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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

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

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Interventional
Phase 1
Phase 2
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  • Breast Neoplasms
  • Chemotherapy
Drug: capecitabine
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
46
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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
Female
18 Years and older
No
Contact: eric levy, md 33-1-56092985 eric.levy@egp.aphp.fr
Contact: kahina rideller, CRA 33-1-56093433 kahina.rideller@egp.aphp.fr
France
 
NCT00324610
CAP 5/7, ARTIC / CAP 5/7
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Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
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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
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
May 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP