RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of docetaxel and ifosfamide in treating women who have metastatic breast cancer.

Condition	Treatment or Intervention	Phase
stage IV breast cancer recurrent breast cancer	Drug: docetaxel  Drug: ifosfamide  Procedure: chemotherapy	Phase II

Further Study Details: 

OBJECTIVES:

• Determine the efficacy of docetaxel and ifosfamide as first-line chemotherapy in women with metastatic breast cancer.
• Determine the response rate and duration of response of patients treated with this regimen.
• Determine the time to treatment failure and survival of patients treated with this regimen.
• Determine the toxicity of this regimen in these patients.
• Determine the quality of life of patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive docetaxel IV over 1 hour on day 1 and ifosfamide IV over 1 hour (beginning 1 hour after docetaxel infusion) on days 1-3. Treatment continues every 4 weeks in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline, every month during study, and then every 3 months after completion of study.

Patients are followed every 3 months.

PROJECTED ACCRUAL: A total of 15-42 patients will be accrued for this study.

Ages Eligible for Study:  21 Years   -   75 Years,  Genders Eligible for Study:  Both

Criteria

DISEASE CHARACTERISTICS:

• Histologically confirmed metastatic breast cancer
• Bidimensionally measurable lesions
• The following are not considered measurable:
• Bone lesions
• Leptomeningeal disease
• Ascites
• Pleural/pericardial effusion
• Inflammatory breast disease
• Lymphangitis cutis/pulmonis
• Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation
• No CNS metastases
• Hormone receptor status:
• Not specified

PATIENT CHARACTERISTICS: Age:

• 21 to 75

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• ECOG 0-2 OR
• Zubrod 0-2

Life expectancy:

• More than 12 weeks

Hematopoietic:

• WBC at least 4,000/mm^3
• Platelet count at least 100,000/mm^3
• Hemoglobin at least 11 g/dL

Hepatic:

• Bilirubin no greater than 1.25 times upper limit of normal (ULN)
• SGOT no greater than 1.25 times ULN

Renal:

• Creatinine clearance at least 60 mL/min

Cardiovascular:

• No history of congestive heart failure
• No myocardial infarction within the past 6 months
• No active ischemic heart disease
• No uncontrolled hypertension

Other:

• Not pregnant
• No other prior or concurrent malignancy except properly treated basal cell skin cancer or carcinoma in situ of the cervix
• No other medical or psychiatric diseases that would preclude study
• No geographical situation that would preclude study
• No history of alcohol abuse

PRIOR CONCURRENT THERAPY: Biologic therapy:

• Not specified

Chemotherapy:

• No prior adjuvant chemotherapy including ifosfamide or docetaxel
• No prior systemic chemotherapy for metastatic breast cancer

Endocrine therapy:

• See Disease Characteristics
• No concurrent corticoids, gestagens, or androgens unless strictly indicated

Radiotherapy:

• Not specified

Surgery:

• Not specified

Other:

• No concurrent drinks containing caffeine or alcohol

Argentina
      C.O.P.M.P., Mar del Plata,  7600,  Argentina; Recruiting
      Centro Oncologico Tres Arroyos, Tres Arroyos,  7500,  Argentina; Recruiting
      Unidad Oncologica Del Neuquen, Neuquen,  Argentina; Recruiting
Argentina, Buenos Aires
      Grupo Oncologico Cooperativo del Sur, Bahia Blanca,  Buenos Aires,  8000,  Argentina; Recruiting
      Policlinica Privada Instituto De Medicina Nuclear, Bahia Blanca,  Buenos Aires,  8000,  Argentina; Recruiting
      St. Joseph Health Center, Gonnet,  Buenos Aires,  1987 MB,  Argentina; Recruiting
Argentina, La Pampa
      Sanatorio Santa Rosa S.R.L., Santa Rosa,  La Pampa,  6300,  Argentina; Recruiting
Mexico, Jalisco
      Centro Medico Nacional de Occidente, Guadalajara,  Jalisco,  4430,  Mexico; Recruiting

Study chairs or principal investigators

Bernardo A. Leone, MD,  Study Chair,  Unidad Oncologica Del Neuquen   

Study ID Numbers:  CDR0000068969; GOCS-02-BR-01; NCI-V01-1670; NCT00026078
Record last reviewed:  November 2001
Last Updated:  December 6, 2004
Record first received:  November 9, 2001
ClinicalTrials.gov Identifier:  NCT00026078
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08