Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
NCT ID: NCT00006120
Last Updated: 2008-07-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2
INTERVENTIONAL
2000-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
* Compare the response rate, progression free survival, and overall survival in women with unresectable locally advanced or metastatic breast cancer treated with two different schedules of docetaxel or paclitaxel.
* Compare the toxicities and pharmacoeconomics of these four regimens in these patients.
* Compare the quality of life of patients treated with these four regimens.
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.
* Arm I: Patients receive docetaxel IV over 1 hour on day 1.
* Arm II: Patients receive paclitaxel IV over 3 hours on day 1.
* Arm III: Patients receive docetaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
* Arm IV: Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, and 36.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
TREATMENT
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
docetaxel
paclitaxel
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
18 Years
75 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
GERCOR - Multidisciplinary Oncology Cooperative Group
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Joseph Gligorov, MD
Role: STUDY_CHAIR
Hopital Tenon
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Centre Hospitalier d'Antibes
Antibes, , France
Centre Hospitalier Victor Dupouy
Argenteuil, , France
Institut Sainte Catherine
Avignon, , France
Clinique Floreal
Bagnolet, , France
Centre D'Oncologie Du Pays-Basque
Bayonne, , France
C.H.G. Beauvais
Beauvais, , France
Hopital Fontenoy
Chartres, , France
Centre Jean Perrin
Clermont-Ferrand, , France
Hopital Louis Mourier
Colombes, , France
Centre Hospitalier Laennec
Creil, , France
Hopital Intercommunal De Creteil
Créteil, , France
Hopital Drevon
Dijon, , France
Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
Gien, , France
Centre Jean Bernard
Le Mans, , France
Hopital Desgenettes - Service de Medecine Interne
Lyon, , France
Centre de Radiotherapie et Oncologie Saint-Faron
Mareuil-lès-Meaux, , France
Hopital Saint Joseph
Marseille, , France
Hopital Notre-Dame de Bon Secours
Metz, , France
CH Meulan
Meulan-en-Yvelines, , France
Intercommunal Hospital
Montfermeil, , France
Centre Hospitalier de Mulhouse
Mulhouse, , France
Clinique Hartmann
Neuilly-sur-Seine, , France
American Hospital of Paris
Neuilly-sur-Seine, , France
Clinique Geoffroy St. Hillaire
Paris, , France
Hotel Dieu de Paris
Paris, , France
Hopital Saint Antoine
Paris, , France
Hopital Tenon
Paris, , France
Clinique Ste - Marie
Pontoise, , France
Polyclinique De Courlancy
Reims, , France
Centre du Rouget
Sarcelles, , France
C.H. Senlis
Senlis, , France
Clinique de l'Orangerie
Strasbourg, , France
Clinique Pasteur
Toulouse, , France
Clinique Fleming
Tours, , France
Hopital de la Ville D'Esch-sur-Alzette
Esch-sur-Alzette, , Luxembourg
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
FRE-GERCOR-TAXMAX-SOO-1
Identifier Type: -
Identifier Source: secondary_id
EU-20029
Identifier Type: -
Identifier Source: secondary_id
CDR0000068134
Identifier Type: -
Identifier Source: org_study_id