Clinical trial NCT00006120: Docetaxel or Paclitaxel in Treating Women With Unresectable Locally Advanced or Metastatic Breast Cancer
Official title: Phase II Randomized Study of Two Different Schedules of Docetaxel or Paclitaxel for Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Breast Cancer
Keywords: stage IV breast cancer
stage IIIA breast cancer
recurrent breast cancer
stage IIIB breast cancer
Lead sponsor: National Cancer Institute (NCI)
Sponsor class: NIH
First posted: 2003-01-27
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Primary purpose: TREATMENT

Brief 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.

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.

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

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