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Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

Primary Purpose

Breast Cancer, Neoplasm Metastasis

Status
Completed
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Paclitaxel
Capecitabine
Sponsored by
ARCAGY/ GINECO GROUP
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

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

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

Sites / Locations

  • Hôpital HOTEL DIEU

Outcomes

Primary Outcome Measures

tolerance of the patients in the both groups.

Secondary Outcome Measures

- Response rates and duration of response.
- Haematological and non-haematological toxicities.
- Progression free survival.
- Overall survival.

Full Information

First Posted
December 26, 2005
Last Updated
February 24, 2011
Sponsor
ARCAGY/ GINECO GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT00270491
Brief Title
Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
ARCAGY/ GINECO GROUP

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Neoplasm Metastasis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Paclitaxel
Intervention Type
Drug
Intervention Name(s)
Capecitabine
Primary Outcome Measure Information:
Title
tolerance of the patients in the both groups.
Secondary Outcome Measure Information:
Title
- Response rates and duration of response.
Title
- Haematological and non-haematological toxicities.
Title
- Progression free survival.
Title
- Overall survival.

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rémy LARGILLIER, Physician
Organizational Affiliation
Centre ANTOINE LACASSAGNE - NICE (FRANCE)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital HOTEL DIEU
City
Paris
ZIP/Postal Code
75004
Country
France

12. IPD Sharing Statement

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Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

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