Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen
NCT ID: NCT00324610
Last Updated: 2006-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE1/PHASE2
46 participants
INTERVENTIONAL
2006-03-31
Brief Summary
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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
Detailed Description
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Conditions
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Interventions
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capecitabine
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
FEMALE
No
Sponsors
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Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
OTHER
Principal Investigators
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eric levy, MD
Role: PRINCIPAL_INVESTIGATOR
HEGP , PARIS
joseph Gligorov, MD
Role: STUDY_CHAIR
HOPITAL TENON, PARIS
Michèle TUBIANA HULIN, MD
Role: STUDY_CHAIR
CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE
VERONIQUE DIERAS, MD
Role: STUDY_CHAIR
INSTITUT CURIE, PARIS france
Rémi LARGILLIER, MD
Role: STUDY_CHAIR
centre antoine lacassagne, NICE, France
Locations
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Ho¨Pital Europeen Georges Pompidou
Paris, , France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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ARTIC / CAP 5/7
Identifier Type: -
Identifier Source: secondary_id
CAP 5/7
Identifier Type: -
Identifier Source: org_study_id