- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00324610
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
Study Overview
Study Type
Enrollment
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Contact
- Name: ERIC LEVY, MD
- Phone Number: 33-1-56092985
- Email: eric.levy@egp.aphp.fr
Study Contact Backup
- Name: kahina rideller, CRA
- Phone Number: 33-1-56093433
- Email: kahina.rideller@egp.aphp.fr
Study Locations
-
-
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Paris, France, 75015
- Recruiting
- Ho¨Pital Europeen Georges Pompidou
-
Contact:
- ERIC LEVY, MD
- Phone Number: 33-1-56092985
- Email: eric.levy@egp.aphp.fr
-
Sub-Investigator:
- jacques medioni, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Collaborators and Investigators
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
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
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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