Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie (Other)

Overall Status

Unknown status

CT.gov ID

NCT00324610

Collaborator

(none)

Enrollment

Location

Study Details

Study Description

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 Design

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

Study Start Date :

Mar 1, 2006

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Ho¨Pital Europeen Georges Pompidou	Paris		France	75015

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