Capecitabine Associated With Weekly Paclitaxel in Metastatic Breast Cancer.
This study has been completed.
Sponsor:
ARCAGY/ GINECO GROUP
Information provided by:
ARCAGY/ GINECO GROUP
ClinicalTrials.gov Identifier:
NCT00270491
First received: December 26, 2005
Last updated: February 24, 2011
Last verified: February 2011
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Purpose
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 | Intervention | Phase |
|---|---|---|
|
Breast Cancer Neoplasm Metastasis |
Drug: Paclitaxel Drug: Capecitabine |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: 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. |
Resource links provided by NLM:
Further study details as provided by ARCAGY/ GINECO GROUP:
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.
| Estimated Enrollment: | 130 |
| Study Start Date: | December 2005 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
More Information
No publications provided
| ClinicalTrials.gov Identifier: | NCT00270491 History of Changes |
| Other Study ID Numbers: | TAXEL |
| Study First Received: | December 26, 2005 |
| Last Updated: | February 24, 2011 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms Neoplasm Metastasis Neoplasms by Site Breast Diseases Skin Diseases Neoplastic Processes Pathologic Processes Paclitaxel Capecitabine Fluorouracil Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses Antimetabolites, Antineoplastic Antimetabolites Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on May 16, 2013