CClinicalTrials.gg
Status unknownNCT00006120Updated Jul 24, 2008

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

A Phase 2 interventional study of docetaxel and paclitaxel in Breast Cancer, sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group. Status unknown at 35 sites in 2 countries. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2008-07-24.

Sponsored by GERCOR - Multidisciplinary Oncology Cooperative Group · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Mar 2006), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage IV breast cancer
  • stage IIIA breast cancer
  • recurrent breast cancer
  • stage IIIB breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

Browse Breast Neoplasms studies →

Lead sponsor

GERCOR - Multidisciplinary Oncology Cooperative Group is the lead sponsor of 76 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
Female
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
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized

Interventions

  • Drugdocetaxel
  • Drugpaclitaxel
06

Study locations

35 sites
  • Centre Hospitalier d'Antibes
    Antibes, 06606, France
  • Centre Hospitalier Victor Dupouy
    Argenteuil, 95107, France
  • Institut Sainte Catherine
    Avignon, 84082, France
  • Clinique Floreal
    Bagnolet, 28630, France
  • Centre D'Oncologie Du Pays-Basque
    Bayonne, F-64100, France
  • C.H.G. Beauvais
    Beauvais, 60021, France
  • Hopital Fontenoy
    Chartres, 28018, France
  • Centre Jean Perrin
    Clermont-Ferrand, 63011, France
  • Hopital Louis Mourier
    Colombes, France
  • Centre Hospitalier Laennec
    Creil, 60109, France
  • Hopital Intercommunal De Creteil
    Creteil, 94010, France
  • Hopital Drevon
    Dijon, 21000, France
  • Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie
    Gien, 45500, France
  • Centre Jean Bernard
    Le Mans, 72000, France
  • Hopital Desgenettes - Service de Medecine Interne
    Lyon, 69998, France
  • Centre de Radiotherapie et Oncologie Saint-Faron
    Mareuil Les Meaux, 77100, France
  • Hopital Saint Joseph
    Marseille, 13008, France
  • Hopital Notre-Dame de Bon Secours
    Metz, 57038, France
  • CH Meulan
    Meulan, 78250, France
  • Intercommunal Hospital
    Montfermeil, 93370, France
  • Centre Hospitalier de Mulhouse
    Mulhouse, 68051, France
  • Clinique Hartmann
    Neuilly sur Seine, 92200, France
  • American Hospital of Paris
    Neuilly Sur Seine, F-92202, France
  • Clinique Geoffroy St. Hillaire
    Paris, 75005, France
  • Hotel Dieu de Paris
    Paris, 75181, France
  • Hopital Saint Antoine
    Paris, 75571, France
  • Hopital Tenon
    Paris, 75970, France
  • Clinique Ste - Marie
    Pontoise, 95301, France
  • Polyclinique De Courlancy
    Reims, F-51100, France
  • Centre du Rouget
    Sarcelles, 95250, France
  • C.H. Senlis
    Senlis, 60309, France
  • Clinique de l'Orangerie
    Strasbourg, 67010, France
  • Clinique Pasteur
    Toulouse, 31076, France
  • Clinique Fleming
    Tours, 37000, France
  • Hopital de la Ville D'Esch-sur-Alzette
    Esch-sur-Alzette, L-4005, Luxembourg
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 24, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00006120
Lead sponsor
GERCOR - Multidisciplinary Oncology Cooperative Group
First posted
Jan 27, 2003
Start date
May 2000
Last update
Jul 24, 2008

Study contacts

Joseph Gligorov, MD
study chair · Hopital Tenon
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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