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

This study is no longer recruiting patients.

Sponsored by: GERCOR
Information provided by: National Cancer Institute (NCI)

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 Treatment or Intervention Phase
stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
 Drug: docetaxel
 Drug: paclitaxel
 Procedure: chemotherapy
Phase II

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel in Women With Unresectable Locally Advanced or Metastatic Breast Cancer

Further Study Details: 

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.

  • 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   -   75 Years,  Genders Eligible for Study:  Both

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:


Location Information


France
      American Hospital of Paris, Neuilly-sur-Seine,  F-92202,  France

      C.H. Senlis, Senlis,  60309,  France

      C.H.G. Beauvais, Beauvais,  60021,  France

      Centre de Radiotherapie et Oncologie Saint-Faron, Mareuil-les-Meaux,  77100,  France

      Centre D'Oncologie Du Pays-Basque, Bayonne,  F-64100,  France

      Centre du Rouget, Sarcelles,  95250,  France

      Centre Hospitalier d'Antibes, Antibes,  06606,  France

      Centre Hospitalier de Mulhouse, Mulhouse,  68051,  France

      Centre Hospitalier Laennec, Creil,  60109,  France

      Centre Hospitalier Victor Dupouy, Argenteuil,  95107,  France

      Centre Jean Bernard, Le Mans,  72000,  France

      Centre Jean Perrin, Clermont-Ferrand,  63011,  France

      CH Meulan, Meulan,  78250,  France

      Clinique de l'Orangerie, Strasbourg,  67010,  France

      Clinique Fleming, Tours,  37000,  France

      Clinique Floreal, Bagnolet,  28630,  France

      Clinique Geoffroy St. Hillaire, Paris,  75005,  France

      Clinique Hartmann, Neuilly-sur-Seine,  92200,  France

      Clinique Pasteur, Toulouse,  31076,  France

      Clinique Ste - Marie, Pontoise,  95301,  France

      Hopital Desgenettes - Service de Medecine Interne, Lyon,  69998,  France

      Hopital Drevon, Dijon,  21000,  France

      Hopital Fontenoy, Chartres,  28018,  France

      Hopital Intercommunal De Creteil, Creteil,  94010,  France

      Hopital Louis Mourier, Colombes,  France

      Hopital Notre-Dame de Bon Secours, Metz,  57038,  France

      Hopital Saint Antoine, Paris,  75571,  France

      Hopital Saint Joseph, Marseille,  13008,  France

      Hopital Tenon, Paris,  75970,  France

      Hotel Dieu de Paris, Paris,  75181,  France

      Institut Sainte Catherine, Avignon,  84082,  France

      Intercommunal Hospital, Montfermeil,  93370,  France

      Polyclinique De Courlancy, Reims,  F-51100,  France

      Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie, Gien,  45500,  France

Luxembourg
      Hopital de la Ville D'Esch-sur-Alzette, Esch-sur-Alzette,  L-4005,  Luxembourg

Study chairs or principal investigators

Joseph Gligorov, MD,  Study Chair,  Hopital Tenon   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000068134; FRE-GERCOR-TAXMAX-SOO-1; EU-20029
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  August 3, 2000
ClinicalTrials.gov Identifier:  NCT00006120
Health Authority: Unspecified
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005