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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00006120
• Other study ID #: CDR0000068134
• Secondary ID: FRE-GERCOR-TAXMA
• Status: Active, not recruiting
• Phase: Phase 2
• First received: August 3, 2000
• Last updated: July 23, 2008
• Start date: May 2000

Study information

• Verified date: March 2006
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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 cancer.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 0
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• docetaxel

• paclitaxel

Locations

Country	Name	City	State
France	Centre Hospitalier d'Antibes	Antibes
France	Centre Hospitalier Victor Dupouy	Argenteuil
France	Institut Sainte Catherine	Avignon
France	Clinique Floreal	Bagnolet
France	Centre D'Oncologie Du Pays-Basque	Bayonne
France	C.H.G. Beauvais	Beauvais
France	Hopital Fontenoy	Chartres
France	Centre Jean Perrin	Clermont-Ferrand
France	Hopital Louis Mourier	Colombes
France	Centre Hospitalier Laennec	Creil
France	Hopital Intercommunal De Creteil	Creteil
France	Hopital Drevon	Dijon
France	Polyclinique Jeanne d'Arc - service de Radiotherapie Oncologie	Gien
France	Centre Jean Bernard	Le Mans
France	Hopital Desgenettes - Service de Medecine Interne	Lyon
France	Centre de Radiotherapie et Oncologie Saint-Faron	Mareuil Les Meaux
France	Hopital Saint Joseph	Marseille
France	Hopital Notre-Dame de Bon Secours	Metz
France	CH Meulan	Meulan
France	Intercommunal Hospital	Montfermeil
France	Centre Hospitalier de Mulhouse	Mulhouse
France	American Hospital of Paris	Neuilly Sur Seine
France	Clinique Hartmann	Neuilly sur Seine
France	Clinique Geoffroy St. Hillaire	Paris
France	Hopital Saint Antoine	Paris
France	Hopital Tenon	Paris
France	Hotel Dieu de Paris	Paris
France	Clinique Ste - Marie	Pontoise
France	Polyclinique De Courlancy	Reims
France	Centre du Rouget	Sarcelles
France	C.H. Senlis	Senlis
France	Clinique de l'Orangerie	Strasbourg
France	Clinique Pasteur	Toulouse
France	Clinique Fleming	Tours
Luxembourg	Hopital de la Ville D'Esch-sur-Alzette	Esch-sur-Alzette

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Cooperateur Multidisciplinaire en Oncologie (GERCOR)

Countries where clinical trial is conducted

France,  Luxembourg,