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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2006 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00006120
First received: August 3, 2000
Last updated: July 23, 2008
Last verified: March 2006
  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 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: May 2000
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00006120

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
Hopital Tenon
Paris, France, 75970
Clinique Geoffroy St. Hillaire
Paris, France, 75005
Hotel Dieu de Paris
Paris, France, 75181
Hopital Saint Antoine
Paris, France, 75571
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
Sponsors and Collaborators
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)
Investigators
Study Chair: Joseph Gligorov, MD Hopital Tenon
  More Information

Additional Information:
No publications provided

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

Keywords provided by National Cancer Institute (NCI):
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Docetaxel
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on October 22, 2014