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| Sponsor: | Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR) |
|---|---|
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00006120 |
Purpose
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Randomized phase II trial to compare the effectiveness of two different regimens of docetaxel or paclitaxel in treating women who have unresectable locally advanced or metastatic breast cancer.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: docetaxel Drug: paclitaxel |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Primary Purpose: Treatment |
| Official Title: | Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer |
| Study Start Date: | May 2000 |
OBJECTIVES:
OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, ECOG performance status, hormone receptor status (positive vs negative), metastasis to liver (yes vs no), and presence of disease progression following anthracyclines (yes vs no).
Patients are randomized to one of four treatment arms.
Courses repeat every 3 weeks (arms I and II) or every 8 weeks (arms III and IV) in the absence of disease progression or unacceptable toxicity.
Quality of life is assessed prior to treatment and then every 8 weeks.
PROJECTED ACCRUAL: A total of 165 patients will be accrued for this study.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven unresectable locally advanced or metastatic breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| France | |
| Centre Hospitalier d'Antibes | |
| Antibes, France, 06606 | |
| Centre Hospitalier Victor Dupouy | |
| Argenteuil, France, 95107 | |
| Institut Sainte Catherine | |
| Avignon, France, 84082 | |
| Clinique Floreal | |
| Bagnolet, France, 28630 | |
| Centre D'Oncologie Du Pays-Basque | |
| Bayonne, France, F-64100 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| Hopital Fontenoy | |
| Chartres, France, 28018 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| Hopital Louis Mourier | |
| Colombes, France | |
| Centre Hospitalier Laennec | |
| Creil, France, 60109 | |
| Hopital Intercommunal De Creteil | |
| Creteil, France, 94010 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie | |
| Gien, France, 45500 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Hopital Desgenettes - Service de Medecine Interne | |
| Lyon, France, 69998 | |
| Centre de Radiotherapie et Oncologie Saint-Faron | |
| Mareuil Les Meaux, France, 77100 | |
| Hopital Saint Joseph | |
| Marseille, France, 13008 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 57038 | |
| CH Meulan | |
| Meulan, France, 78250 | |
| Intercommunal Hospital | |
| Montfermeil, France, 93370 | |
| Centre Hospitalier de Mulhouse | |
| Mulhouse, France, 68051 | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| Clinique Hartmann | |
| Neuilly sur Seine, France, 92200 | |
| Clinique Geoffroy St. Hillaire | |
| Paris, France, 75005 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95301 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Centre du Rouget | |
| Sarcelles, France, 95250 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| Clinique Fleming | |
| Tours, France, 37000 | |
| Luxembourg | |
| Hopital de la Ville D'Esch-sur-Alzette | |
| Esch-sur-Alzette, Luxembourg, L-4005 | |
| Study Chair: | Joseph Gligorov, MD | Hopital Tenon |
More Information
| ClinicalTrials.gov Identifier: | NCT00006120 History of Changes |
| Other Study ID Numbers: | CDR0000068134, FRE-GERCOR-TAXMAX-SOO-1, EU-20029 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer |
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Paclitaxel Docetaxel Tubulin Modulators |
Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Antineoplastic Agents, Phytogenic Antineoplastic Agents Therapeutic Uses |