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Breast CancerPhase 2NCT00006120

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

A Phase 2 study testing docetaxel and paclitaxel in people with Breast Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 35 sites in 2 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
docetaxel and paclitaxel
How many people
Not given
Where
35 sitesin 2 countries
Study dates
May 2000to not given
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

35 sites in 2 countries.

35 sites in 2 countries

France34 sites

  • Centre Hospitalier d'Antibes

    Antibes, 06606

  • Centre Hospitalier Victor Dupouy

    Argenteuil, 95107

  • Institut Sainte Catherine

    Avignon, 84082

  • Clinique Floreal

    Bagnolet, 28630

  • Centre D'Oncologie Du Pays-Basque

    Bayonne, F-64100

  • C.H.G. Beauvais

    Beauvais, 60021

  • Hopital Fontenoy

    Chartres, 28018

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

  • Hopital Louis Mourier

    Colombes

  • Centre Hospitalier Laennec

    Creil, 60109

  • Hopital Intercommunal De Creteil

    Créteil, 94010

  • Hopital Drevon

    Dijon, 21000

  • Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie

    Gien, 45500

  • Centre Jean Bernard

    Le Mans, 72000

  • Hopital Desgenettes - Service de Medecine Interne

    Lyon, 69998

  • Centre de Radiotherapie et Oncologie Saint-Faron

    Mareuil-lès-Meaux, 77100

  • Hopital Saint Joseph

    Marseille, 13008

  • Hopital Notre-Dame de Bon Secours

    Metz, 57038

  • CH Meulan

    Meulan-en-Yvelines, 78250

  • Intercommunal Hospital

    Montfermeil, 93370

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68051

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200

  • American Hospital of Paris

    Neuilly-sur-Seine, F-92202

  • Clinique Geoffroy St. Hillaire

    Paris, 75005

  • Hotel Dieu de Paris

    Paris, 75181

  • Hopital Saint Antoine

    Paris, 75571

  • Hopital Tenon

    Paris, 75970

  • Clinique Ste - Marie

    Pontoise, 95301

  • Polyclinique De Courlancy

    Reims, F-51100

  • Centre du Rouget

    Sarcelles, 95250

  • C.H. Senlis

    Senlis, 60309

  • Clinique de l'Orangerie

    Strasbourg, 67010

  • Clinique Pasteur

    Toulouse, 31076

  • Clinique Fleming

    Tours, 37000

Other trials in France

Luxembourg1 site

  • Hopital de la Ville D'Esch-sur-Alzette

    Esch-sur-Alzette, L-4005

Other trials in Luxembourg

About this study

Official title: 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.

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.

Conditions
Breast Cancer
Being tested
docetaxel, paclitaxel
Keywords
stage IV breast cancer, stage IIIA breast cancer, recurrent breast cancer, stage IIIB breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startMay 2000

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
IDs, dates and publications
ClinicalTrials.gov ID
NCT00006120
Sponsor's protocol ID
CDR0000068134
Other IDs
FRE-GERCOR-TAXMAX-SOO-1, EU-20029
Status last verified
Mar 2006
First submitted
3 Aug 2000
Last updated
24 Jul 2008
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing docetaxel and paclitaxel in people with Breast Cancer, run by GERCOR - Multidisciplinary Oncology Cooperative Group at 35 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 35 sites in France, Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00006120.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2008.

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