Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer

NCT00006120 | Unknown Phase 2

• 3 other identifiers: CDR0000068134FRE-GERCOR-TAXMAX-SOO-1EU-20029
• Study Type: interventional
• Target: N/A
• Locations: 2 countries
• Sites: 35

Brief Summary

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.

Conditions

Breast Cancer

Keywords

stage IV breast cancer; stage IIIA breast cancer; recurrent breast cancer; stage IIIB breast cancer

Interventions

docetaxel DRUG

paclitaxel DRUG

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically proven unresectable locally advanced or metastatic breast cancer * Refractory or relapsed disease after neoadjuvant or adjuvant anthracyclines * At least one bidimensionally measurable lesion * No brain metastasis * No bone metastases, lymphangitis carcinomatous, ascites, or pleural effusion as sole site of metastatic disease * Hormone receptor status: * Known hormone receptor status PATIENT CHARACTERISTICS: Age: * 18 to 75 Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 OR * Karnofsky 60-100% Life expectancy: * At least 12 weeks Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * AST and ALT no greater than 2.5 times upper limit of normal (ULN) * Alkaline phosphatase no greater than 2.5 times ULN * Bilirubin normal Renal: * Creatinine no greater than 1.5 times ULN Cardiovascular: * No uncontrolled angina or arrhythmia * No myocardial infarction within the past 6 months * No New York Heart Association class III or IV heart disease Other: * No sensitive neuropathy worse than grade 2 * No other significant, uncontrolled medical or psychiatric condition * No serious active infection * Not pregnant or nursing * Fertile patients must use effective contraception * No other prior malignancy except treated nonmelanomatous skin cancer or carcinoma in situ of the cervix PRIOR CONCURRENT THERAPY: Biologic therapy: * At least 4 weeks since prior specific antitumoral immunotherapy Chemotherapy: * See Disease Characteristics * No prior taxanes * At least 4 weeks since other prior specific antitumoral chemotherapy Endocrine therapy: * At least 4 weeks since prior specific antitumoral hormonal therapy Radiotherapy: * At least 4 weeks since prior specific antitumoral radiotherapy Surgery: * Not specified Other: * No other concurrent experimental medication

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• GERCOR - Multidisciplinary Oncology Cooperative Group: lead

Study Sites (35)

Centre Hospitalier d'Antibes

Antibes, 06606, France

Location

Centre Hospitalier Victor Dupouy

Argenteuil, 95107, France

Location

Institut Sainte Catherine

Avignon, 84082, France

Location

Clinique Floreal

Bagnolet, 28630, France

Location

Centre D'Oncologie Du Pays-Basque

Bayonne, F-64100, France

Location

C.H.G. Beauvais

Beauvais, 60021, France

Location

Hopital Fontenoy

Chartres, 28018, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

Hopital Louis Mourier

Colombes, France

Location

Centre Hospitalier Laennec

Creil, 60109, France

Location

Hopital Intercommunal De Creteil

Créteil, 94010, France

Location

Hopital Drevon

Dijon, 21000, France

Location

Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie

Gien, 45500, France

Location

Centre Jean Bernard

Le Mans, 72000, France

Location

Hopital Desgenettes - Service de Medecine Interne

Lyon, 69998, France

Location

Centre de Radiotherapie et Oncologie Saint-Faron

Mareuil-lès-Meaux, 77100, France

Location

Hopital Saint Joseph

Marseille, 13008, France

Location

Hopital Notre-Dame de Bon Secours

Metz, 57038, France

Location

CH Meulan

Meulan-en-Yvelines, 78250, France

Location

Intercommunal Hospital

Montfermeil, 93370, France

Location

Centre Hospitalier de Mulhouse

Mulhouse, 68051, France

Location

Clinique Hartmann

Neuilly-sur-Seine, 92200, France

Location

American Hospital of Paris

Neuilly-sur-Seine, F-92202, France

Location

Clinique Geoffroy St. Hillaire

Paris, 75005, France

Location

Hotel Dieu de Paris

Paris, 75181, France

Location

Hopital Saint Antoine

Paris, 75571, France

Location

Hopital Tenon

Paris, 75970, France

Location

Clinique Ste - Marie

Pontoise, 95301, France

Location

Polyclinique De Courlancy

Reims, F-51100, France

Location

Centre du Rouget

Sarcelles, 95250, France

Location

C.H. Senlis

Senlis, 60309, France

Location

Clinique de l'Orangerie

Strasbourg, 67010, France

Location

Clinique Pasteur

Toulouse, 31076, France

Location

Clinique Fleming

Tours, 37000, France

Location

Hopital de la Ville D'Esch-sur-Alzette

Esch-sur-Alzette, L-4005, Luxembourg

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Docetaxel; Paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Joseph Gligorov, MD

  Hopital Tenon

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 3, 2000
• First Posted: January 27, 2003
• Study Start: May 1, 2000
• Last Updated: July 24, 2008

Record last verified: 2006-03

Locations

FR (34); LU (1)