Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

Breast Cancer Clinical Trial

Official title:

A Multicenter Randomized Phase II Study Evaluating Tolerance and Efficacy of Capecitabine 5/7 Days With Weekly Paclitaxel Versus the Recommended Treatment Plan of Weekly Paclitaxel-capecitabine, in Patients With Metastatic Breast Cancer.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00270491
• Other study ID #: TAXEL
• Status: Completed
• Phase: Phase 2
• First received: December 26, 2005
• Last updated: February 24, 2011
• Start date: December 2005
• Est. completion date: October 2010

Study information

• Verified date: February 2011
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2010
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Neoplasm Metastasis

Intervention

Drug:
• Paclitaxel

• Capecitabine

Locations

Country	Name	City	State
France	Hôpital HOTEL DIEU	Paris

Sponsors (1)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	tolerance of the patients in the both groups.
Secondary	- Response rates and duration of response.
Secondary	- Haematological and non-haematological toxicities.
Secondary	- Progression free survival.
Secondary	- Overall survival.