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| Sponsored by: |
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: | Treatment, Randomized, Active Control |
| 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 | |
| American Hospital of Paris | |
| Neuilly Sur Seine, France, F-92202 | |
| C.H. Senlis | |
| Senlis, France, 60309 | |
| C.H.G. Beauvais | |
| Beauvais, France, 60021 | |
| Centre de Radiotherapie et Oncologie Saint-Faron | |
| Mareuil Les Meaux, France, 77100 | |
| Centre D'Oncologie Du Pays-Basque | |
| Bayonne, France, F-64100 | |
| Centre du Rouget | |
| Sarcelles, France, 95250 | |
| Centre Hospitalier d'Antibes | |
| Antibes, France, 06606 | |
| Centre Hospitalier de Mulhouse | |
| Mulhouse, France, 68051 | |
| Clinique Geoffroy St. Hillaire | |
| Paris, France, 75005 | |
| Centre Hospitalier Victor Dupouy | |
| Argenteuil, France, 95107 | |
| Centre Jean Bernard | |
| Le Mans, France, 72000 | |
| Centre Jean Perrin | |
| Clermont-Ferrand, France, 63011 | |
| CH Meulan | |
| Meulan, France, 78250 | |
| Clinique de l'Orangerie | |
| Strasbourg, France, 67010 | |
| Clinique Fleming | |
| Tours, France, 37000 | |
| Clinique Floreal | |
| Bagnolet, France, 28630 | |
| Centre Hospitalier Laennec | |
| Creil, France, 60109 | |
| Clinique Hartmann | |
| Neuilly sur Seine, France, 92200 | |
| Clinique Pasteur | |
| Toulouse, France, 31076 | |
| Clinique Ste - Marie | |
| Pontoise, France, 95301 | |
| Hopital Desgenettes - Service de Medecine Interne | |
| Lyon, France, 69998 | |
| Hopital Drevon | |
| Dijon, France, 21000 | |
| Hopital Notre-Dame de Bon Secours | |
| Metz, France, 57038 | |
| Hopital Intercommunal De Creteil | |
| Creteil, France, 94010 | |
| Hopital Louis Mourier | |
| Colombes, France | |
| Hopital Fontenoy | |
| Chartres, France, 28018 | |
| Hopital Saint Antoine | |
| Paris, France, 75571 | |
| Hopital Saint Joseph | |
| Marseille, France, 13008 | |
| Hopital Tenon | |
| Paris, France, 75970 | |
| Hotel Dieu de Paris | |
| Paris, France, 75181 | |
| Institut Sainte Catherine | |
| Avignon, France, 84082 | |
| Intercommunal Hospital | |
| Montfermeil, France, 93370 | |
| Polyclinique De Courlancy | |
| Reims, France, F-51100 | |
| Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie | |
| Gien, France, 45500 | |
| Luxembourg | |
| Hopital de la Ville D'Esch-sur-Alzette | |
| Esch-sur-Alzette, Luxembourg, L-4005 | |
| Study Chair: | Joseph Gligorov, MD | Hopital Tenon |
More Information
| Study ID Numbers: | CDR0000068134, FRE-GERCOR-TAXMAX-SOO-1, EU-20029 |
| Study First Received: | August 3, 2000 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00006120 History of Changes |
| Health Authority: | United States: Federal Government |
|
stage IV breast cancer stage IIIA breast cancer recurrent breast cancer stage IIIB breast cancer |
|
Docetaxel Skin Diseases Paclitaxel Tubulin Modulators Breast Neoplasms |
Antimitotic Agents Antineoplastic Agents, Phytogenic Breast Diseases Recurrence |
|
Skin Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Mitosis Modulators Breast Neoplasms Antimitotic Agents Pharmacologic Actions Docetaxel |
Neoplasms Neoplasms by Site Paclitaxel Therapeutic Uses Tubulin Modulators Antineoplastic Agents, Phytogenic Breast Diseases |