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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
docetaxel
paclitaxel
Sponsored by
GERCOR - Multidisciplinary Oncology Cooperative Group
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier d'Antibes
  • Centre Hospitalier Victor Dupouy
  • Institut Sainte Catherine
  • Clinique Floreal
  • Centre D'Oncologie Du Pays-Basque
  • C.H.G. Beauvais
  • Hopital Fontenoy
  • Centre Jean Perrin
  • Hopital Louis Mourier
  • Centre Hospitalier Laennec
  • Hopital Intercommunal De Creteil
  • Hopital Drevon
  • Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
  • Centre Jean Bernard
  • Hopital Desgenettes - Service de Medecine Interne
  • Centre de Radiotherapie et Oncologie Saint-Faron
  • Hopital Saint Joseph
  • Hopital Notre-Dame de Bon Secours
  • CH Meulan
  • Intercommunal Hospital
  • Centre Hospitalier de Mulhouse
  • Clinique Hartmann
  • American Hospital of Paris
  • Clinique Geoffroy St. Hillaire
  • Hotel Dieu de Paris
  • Hopital Saint Antoine
  • Hopital Tenon
  • Clinique Ste - Marie
  • Polyclinique De Courlancy
  • Centre du Rouget
  • C.H. Senlis
  • Clinique de l'Orangerie
  • Clinique Pasteur
  • Clinique Fleming
  • Hopital de la Ville D'Esch-sur-Alzette

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
August 3, 2000
Last Updated
July 23, 2008
Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
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1. Study Identification

Unique Protocol Identification Number
NCT00006120
Brief Title
Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Official Title
Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group

4. Oversight

5. Study Description

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.
Detailed Description
OBJECTIVES: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
docetaxel
Intervention Type
Drug
Intervention Name(s)
paclitaxel

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph Gligorov, MD
Organizational Affiliation
Hopital Tenon
Official's Role
Study Chair
Facility Information:
Facility Name
Centre Hospitalier d'Antibes
City
Antibes
ZIP/Postal Code
06606
Country
France
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Institut Sainte Catherine
City
Avignon
ZIP/Postal Code
84082
Country
France
Facility Name
Clinique Floreal
City
Bagnolet
ZIP/Postal Code
28630
Country
France
Facility Name
Centre D'Oncologie Du Pays-Basque
City
Bayonne
ZIP/Postal Code
F-64100
Country
France
Facility Name
C.H.G. Beauvais
City
Beauvais
ZIP/Postal Code
60021
Country
France
Facility Name
Hopital Fontenoy
City
Chartres
ZIP/Postal Code
28018
Country
France
Facility Name
Centre Jean Perrin
City
Clermont-Ferrand
ZIP/Postal Code
63011
Country
France
Facility Name
Hopital Louis Mourier
City
Colombes
Country
France
Facility Name
Centre Hospitalier Laennec
City
Creil
ZIP/Postal Code
60109
Country
France
Facility Name
Hopital Intercommunal De Creteil
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Drevon
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
City
Gien
ZIP/Postal Code
45500
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Hopital Desgenettes - Service de Medecine Interne
City
Lyon
ZIP/Postal Code
69998
Country
France
Facility Name
Centre de Radiotherapie et Oncologie Saint-Faron
City
Mareuil Les Meaux
ZIP/Postal Code
77100
Country
France
Facility Name
Hopital Saint Joseph
City
Marseille
ZIP/Postal Code
13008
Country
France
Facility Name
Hopital Notre-Dame de Bon Secours
City
Metz
ZIP/Postal Code
57038
Country
France
Facility Name
CH Meulan
City
Meulan
ZIP/Postal Code
78250
Country
France
Facility Name
Intercommunal Hospital
City
Montfermeil
ZIP/Postal Code
93370
Country
France
Facility Name
Centre Hospitalier de Mulhouse
City
Mulhouse
ZIP/Postal Code
68051
Country
France
Facility Name
Clinique Hartmann
City
Neuilly sur Seine
ZIP/Postal Code
92200
Country
France
Facility Name
American Hospital of Paris
City
Neuilly Sur Seine
ZIP/Postal Code
F-92202
Country
France
Facility Name
Clinique Geoffroy St. Hillaire
City
Paris
ZIP/Postal Code
75005
Country
France
Facility Name
Hotel Dieu de Paris
City
Paris
ZIP/Postal Code
75181
Country
France
Facility Name
Hopital Saint Antoine
City
Paris
ZIP/Postal Code
75571
Country
France
Facility Name
Hopital Tenon
City
Paris
ZIP/Postal Code
75970
Country
France
Facility Name
Clinique Ste - Marie
City
Pontoise
ZIP/Postal Code
95301
Country
France
Facility Name
Polyclinique De Courlancy
City
Reims
ZIP/Postal Code
F-51100
Country
France
Facility Name
Centre du Rouget
City
Sarcelles
ZIP/Postal Code
95250
Country
France
Facility Name
C.H. Senlis
City
Senlis
ZIP/Postal Code
60309
Country
France
Facility Name
Clinique de l'Orangerie
City
Strasbourg
ZIP/Postal Code
67010
Country
France
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Facility Name
Clinique Fleming
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Hopital de la Ville D'Esch-sur-Alzette
City
Esch-sur-Alzette
ZIP/Postal Code
L-4005
Country
Luxembourg

12. IPD Sharing Statement

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

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