Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
NCT ID: NCT00026078
Last Updated: 2013-08-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
42 participants
INTERVENTIONAL
2001-03-31
Brief Summary
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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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* 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.
Conditions
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Keywords
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Study Design
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TREATMENT
Interventions
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docetaxel
ifosfamide
Eligibility Criteria
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Inclusion Criteria
* 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
21 Years
75 Years
FEMALE
No
Sponsors
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Grupo Oncologico Cooperativo del Sur
OTHER
Principal Investigators
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Bernardo A. Leone, MD
Role: STUDY_CHAIR
Unidad Oncologica Del Neuquen
Locations
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Grupo Oncologico Cooperativo del Sur
Bahía Blanca, Buenos Aires, Argentina
Policlinica Privada Instituto De Medicina Nuclear
Bahía Blanca, Buenos Aires, Argentina
St. Joseph Medical Center
Manuel B. Gonnet, Buenos Aires, Argentina
Sanatorio Santa Rosa S.R.L.
Santa Rosa, La Pampa Province, Argentina
Unidad Oncologica Del Neuquen
Neuquén, Neuquén Province, Argentina
C.R I O.
Mar del Plata, , Argentina
Centro Oncologico Tres Arroyos
Tres Arroyos, , Argentina
Centro Medico Nacional de Occidente
Guadalajara, Jalisco, Mexico
Countries
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Facility Contacts
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Juan Eduardo Perez, MD
Role: primary
Alberto Omar Romero, MD
Role: primary
Sergio Grasso, MD
Role: primary
Eduardo Heriberto Ortiz, MD
Role: primary
Bernardo A. Leone, MD
Role: primary
Ricardo L. Rodriguez, MD
Role: primary
Maria Ester Dominguez, MD
Role: primary
Gilberto Morgan Villela, MD
Role: primary
Other Identifiers
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CDR0000068969
Identifier Type: REGISTRY
Identifier Source: secondary_id
NCI-V01-1670
Identifier Type: -
Identifier Source: secondary_id
GOCS-02-BR-01
Identifier Type: -
Identifier Source: org_study_id