Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

NCT ID: NCT00270491

Last Updated: 2011-02-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-12-31
• Study Completion Date: 2010-10-31

Brief Summary

Tolerance and efficacy of administration of capecitabine 5 out of 7 days associated with weekly paclitaxel compared to the recommended treatment plan of weekly paclitaxel - capecitabine, in patients with metastatic breast cancer.

Detailed Description

The purpose of this study is to know if we can optimize in term of tolerance even of efficacy the plan of administration of weekly paclitaxel associated with capecitabine.

Conditions

Breast Cancer; Neoplasm Metastasis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Paclitaxel

Intervention Type: DRUG

Capecitabine

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Femal patient aged > 18 years
• Histologically proven breast adenocarcinoma
• HER2 negative receptors
• previously received first or second line chemotherapy for metastatic disease
• previously treated with anthracycline and/or docetaxel in adjuvant and/or as first or second line therapy
• presence of one or several evaluable metastatic lesion(s)
• presence of at least one target lesion not previously irradiated
• previously treated with hormonotherapy in adjuvant or in metastatic line (treatment will be ceased upon patient registration in the study)
• ECOG Performance status < 2
• adequate biological values
• patient who has clearly given her consent by signing on informed consent form prior to participation

Exclusion Criteria

• patient previously treated with paclitaxel or capecitabine for metastatic breast cancer
• patient with only local metastatic disease (with the exception of axillary lymph nodes)
• active symptomatic brain metastasis
• patient with an history of significant cardiovascular impairment (congestive heart failure> NYHA grade II, unstable angina or myocardial infraction within the past six months or serious cardiac arrhythmia)
• peripheric neuropathy grade ≥ 2
• history of another malignancy within past 5 years that could confound diagnosis or staging of breast cancer (with the exception of in situ cacinoma of the cervix or adequately treated basel cell carcinoma of the skin)
• patient with any medical or psychiatric condition that, in the opinion of the Principal Investigator, would preclude her from participating in this study
• patient with a known allergy to one or several of the study compounds
• patients who may not be regularly available due to geographical, social or family reasons
• history of renal, hepatic or metabolic pathology that could preclude with metabolism or elimination of the study product
• deficiencies of the upper intestinal tract, malabsorption syndrome
• patient who is pregnant, breast-feeding or using inadequate contraception

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

ARCAGY/ GINECO GROUP

OTHER

Sponsor Role: lead

Principal Investigators

Rémy LARGILLIER, Physician

Role: PRINCIPAL_INVESTIGATOR

Centre ANTOINE LACASSAGNE - NICE (FRANCE)

Locations

Hôpital HOTEL DIEU

Paris, , France

Countries

France

Other Identifiers

TAXEL

Identifier Type: -

Identifier Source: org_study_id