Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

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Primary Purpose

Status

Unknown status

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

capecitabine

About this trial

This is an interventional trial for Breast Neoplasms focused on measuring fluoropyrimidines, metastases, pharmacokinetics, phase 1-2 study

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Ho¨Pital Europeen Georges PompidouRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00324610

First Posted

May 9, 2006

Last Updated

May 16, 2006

Sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

1. Study Identification

Unique Protocol Identification Number

NCT00324610

Brief Title

Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2006

Overall Recruitment Status

Unknown status

Study Start Date

March 2006 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

4. Oversight

5. 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Neoplasms, Chemotherapy

Keywords

fluoropyrimidines, metastases, pharmacokinetics, phase 1-2 study

7. Study Design

Study Phase

Phase 1, Phase 2

Enrollment

46 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

capecitabine

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

eric levy, md

Phone

33-1-56092985

Email

eric.levy@egp.aphp.fr

First Name & Middle Initial & Last Name or Official Title & Degree

kahina rideller, CRA

Phone

33-1-56093433

Email

kahina.rideller@egp.aphp.fr

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

eric levy, MD

Organizational Affiliation

HEGP , PARIS

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

joseph Gligorov, MD

Organizational Affiliation

HOPITAL TENON, PARIS

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Michèle TUBIANA HULIN, MD

Organizational Affiliation

CENTRE RENE HUGUENIN, SAINT CLOUD, FRANCE

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

VERONIQUE DIERAS, MD

Organizational Affiliation

INSTITUT CURIE, PARIS france

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Rémi LARGILLIER, MD

Organizational Affiliation

centre antoine lacassagne, NICE, France

Official's Role

Study Chair

Facility Information:

Facility Name

Ho¨Pital Europeen Georges Pompidou

City

Paris

ZIP/Postal Code

75015

Country

France

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

ERIC LEVY, MD

Phone

33-1-56092985

Email

eric.levy@egp.aphp.fr

First Name & Middle Initial & Last Name & Degree

jacques medioni, MD

Breast Neoplasms, Chemotherapy

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial