Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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Docetaxel (DTX) - Ifosfamide (IFX) As First Line Chemotherapy In Metastatic Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: docetaxel
* Drug: ifosfamide


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|
|Drug: ifosfamide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage IV breast cancer, recurrent breast cancer