Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.

• Sponsor: ARCAGY/ GINECO GROUP (Other)
• Overall Status: Completed
• CT.gov ID: NCT00270491
• Collaborator: (none)
• Enrollment: 130
• Location: 1
• Duration (Months): 58
• Patients Per Site Per Month: 2.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Neoplasm Metastasis	Drug: Paclitaxel; Drug: Capecitabine	Phase 2

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 130 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Dec 1, 2005
• Actual Primary Completion Date: Oct 1, 2009
• Actual Study Completion Date: Oct 1, 2010

Outcome Measures

Primary Outcome Measures

1. tolerance of the patients in the both groups. []

Secondary Outcome Measures

1. - Response rates and duration of response. []

2. - Haematological and non-haematological toxicities. []

3. - Progression free survival. []

4. - Overall survival. []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hôpital HOTEL DIEU	Paris		France	75004

Sponsors and Collaborators

• ARCAGY/ GINECO GROUP

Investigators

• Principal Investigator: Rémy LARGILLIER, Physician, Centre ANTOINE LACASSAGNE - NICE (FRANCE)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00270491
• Other Study ID Numbers: TAXEL
• First Posted: Dec 28, 2005
• Last Update Posted: Feb 25, 2011
• Last Verified: Feb 1, 2011

• Additional relevant MeSH terms: Breast Neoplasms; Neoplasm Metastasis; Paclitaxel; Capecitabine

Study Results

No Results Posted as of Feb 25, 2011