Breast Cancer
Conditions
Keywords
stage IV breast cancer, recurrent breast cancer
Brief summary
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.
Detailed description
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.
Interventions
DRUGdocetaxel
DRUGifosfamide
Sponsors
Grupo Oncologico Cooperativo del Sur
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 75 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Response rate | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Argentina, Mexico
Outcome results
None listed