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| ID | Type | Description | Link |
|---|---|---|---|
| CDR0000068969 | Registry Identifier | PDQ (Physician Data Query) | |
| NCI-V01-1670 |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| docetaxel | Drug | |||
| ifosfamide | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Response rate |
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment failure | ||
| Duration of response | ||
| Survival |
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DISEASE CHARACTERISTICS:
Histologically confirmed metastatic breast cancer
Bidimensionally measurable lesions
The following are not considered measurable:
Disease progression after hormonal therapy allowed provided at least 1 month since last therapeutic manipulation
No CNS metastases
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age:
Sex:
Menopausal status:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
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| Name | Affiliation | Role |
|---|---|---|
| Bernardo A. Leone, MD | Unidad Oncologica Del Neuquen | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Grupo Oncologico Cooperativo del Sur | Recruiting | Bahía Blanca | Buenos Aires | 8000 | Argentina |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077143 | Docetaxel |
| D007069 | Ifosfamide |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
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| Toxicity as assessed by CTC version 2.0 |
| Quality of life as assessed by Schipper's Functional Living Index - Cancer |
| Policlinica Privada Instituto De Medicina Nuclear | Recruiting | Bahía Blanca | Buenos Aires | 8000 | Argentina |
|
| St. Joseph Medical Center | Recruiting | Manuel B. Gonnet | Buenos Aires | 1987 MB | Argentina |
|
| Sanatorio Santa Rosa S.R.L. | Recruiting | Santa Rosa | La Pampa Province | 6300 | Argentina |
|
| Unidad Oncologica Del Neuquen | Recruiting | Neuquén | Neuquén Province | Argentina |
|
| C.R I O. | Recruiting | Mar del Plata | 7600 | Argentina |
|
| Centro Oncologico Tres Arroyos | Recruiting | Tres Arroyos | 7500 | Argentina |
|
| Centro Medico Nacional de Occidente | Recruiting | Guadalajara | Jalisco | 4430 | Mexico |
|
| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D003520 | Cyclophosphamide |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |