Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

Grupo Oncologico Cooperativo del Sur42 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Enrollment

Conditions

Breast Cancer

Interventions

docetaxelDRUG

ifosfamideDRUG

Eligibility

Sex: FEMALEMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (8)

Grupo Oncologico Cooperativo del Sur

Bahía Blanca, Buenos Aires, Argentina

RECRUITING

Policlinica Privada Instituto De Medicina Nuclear

Bahía Blanca, Buenos Aires, Argentina

RECRUITING

St. Joseph Medical Center

Outcomes

Primary Outcomes

Response rate

Secondary Outcomes

Time to treatment failure

Duration of response

Survival

Toxicity as assessed by CTC version 2.0

Quality of life as assessed by Schipper's Functional Living Index - Cancer

Data from ClinicalTrials.gov

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