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

July 23, 2008 updated by: GERCOR - Multidisciplinary Oncology Cooperative Group

Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Antibes, France, 06606
        • Centre Hospitalier d'Antibes
      • Argenteuil, France, 95107
        • Centre Hospitalier Victor Dupouy
      • Avignon, France, 84082
        • Institut Sainte Catherine
      • Bagnolet, France, 28630
        • Clinique Floreal
      • Bayonne, France, F-64100
        • Centre d'Oncologie du Pays-Basque
      • Beauvais, France, 60021
        • C.H.G. Beauvais
      • Chartres, France, 28018
        • Hopital Fontenoy
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Colombes, France
        • Hôpital Louis Mourier
      • Creil, France, 60109
        • Centre Hospitalier LAENNEC
      • Creteil, France, 94010
        • Hôpital Intercommunal de Créteil
      • Dijon, France, 21000
        • Hopital Drevon
      • Gien, France, 45500
        • Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
      • Le Mans, France, 72000
        • Centre Jean Bernard
      • Lyon, France, 69998
        • Hopital Desgenettes - Service de Medecine Interne
      • Mareuil Les Meaux, France, 77100
        • Centre de Radiotherapie et Oncologie Saint-Faron
      • Marseille, France, 13008
        • Hopital Saint Joseph
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Meulan, France, 78250
        • CH Meulan
      • Montfermeil, France, 93370
        • Intercommunal Hospital
      • Mulhouse, France, 68051
        • Centre Hospitalier de Mulhouse
      • Neuilly Sur Seine, France, F-92202
        • American Hospital of Paris
      • Neuilly sur Seine, France, 92200
        • Clinique Hartmann
      • Paris, France, 75970
        • Hôpital Tenon
      • Paris, France, 75571
        • Hôpital Saint Antoine
      • Paris, France, 75181
        • Hotel Dieu de Paris
      • Paris, France, 75005
        • Clinique Geoffroy St. Hillaire
      • Pontoise, France, 95301
        • Clinique Ste - Marie
      • Reims, France, F-51100
        • Polyclinique de Courlancy
      • Sarcelles, France, 95250
        • Centre du Rouget
      • Senlis, France, 60309
        • C.H. Senlis
      • Strasbourg, France, 67010
        • Clinique de l'Orangerie
      • Toulouse, France, 31076
        • Clinique Pasteur
      • Tours, France, 37000
        • Clinique Fleming
  • Luxembourg
      • Esch-sur-Alzette, Luxembourg, L-4005
        • Hopital de la Ville D'Esch-sur-Alzette

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group

Investigators

  • Study Chair: Joseph Gligorov, MD, Hôpital Tenon

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2000

Study Registration Dates

First Submitted

August 3, 2000

First Submitted That Met QC Criteria

January 26, 2003

First Posted (Estimate)

January 27, 2003

Study Record Updates

Last Update Posted (Estimate)

July 24, 2008

Last Update Submitted That Met QC Criteria

July 23, 2008

Last Verified

March 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000068134
  • FRE-GERCOR-TAXMAX-SOO-1
  • EU-20029

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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