Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

This study is currently recruiting participants.

Verified by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie, May 2006

Sponsored by:	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
Information provided by:	Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
ClinicalTrials.gov Identifier:	NCT00324610

Purpose

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	Intervention	Phase
Breast Neoplasms Chemotherapy	Drug: capecitabine	Phase I Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Capecitabine

U.S. FDA Resources

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

Further study details as provided by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie:

Estimated Enrollment:	46
Study Start Date:	March 2006

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: 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

More Information

Study ID Numbers:	CAP 5/7, ARTIC / CAP 5/7
Study First Received:	May 9, 2006
Last Updated:	May 16, 2006
ClinicalTrials.gov Identifier:	NCT00324610
Health Authority:	France: Comité National d'Ethique

Keywords provided by Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie:

fluoropyrimidines
metastases
pharmacokinetics
phase 1-2 study

Study placed in the following topic categories:

Capecitabine
Skin Diseases
Neoplasm Metastasis
Breast Neoplasms
Breast Diseases

Additional relevant MeSH terms:

Antimetabolites
Neoplasms
Antimetabolites, Antineoplastic
Neoplasms by Site

Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009