Tolerance and Pharmacokinetics With Capecitabine 5 Out of 7 Days Regimen

Breast Neoplasms Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00324610
• Other study ID #: CAP 5/7
• Secondary ID: ARTIC / CAP 5/7
• Status: Recruiting
• Phase: Phase 1/Phase 2
• First received: May 9, 2006
• Last updated: May 16, 2006
• Start date: March 2006

Study information

• Verified date: May 2006
• Source: Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie
• Contact: eric levy, md
• Phone: 33-1-56092985
• Email: eric.levy[@]egp.aphp.fr
• Is FDA regulated: No
• Health authority: France: Comité National d'Ethique
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 46
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

N/A

Related Conditions & MeSH terms

• Breast Neoplasms
• Chemotherapy

Intervention

Drug:
• capecitabine

Locations

Country	Name	City	State
France	Ho¨Pital Europeen Georges Pompidou	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association Pour La Recherche des Thérapeutiques Innovantes en Cancérologie

Country where clinical trial is conducted

France,