Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00026078
- Lead Sponsor
- Grupo Oncologico Cooperativo del Sur
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 42
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response rate
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (8)
C.R I O.
🇦🇷Mar del Plata, Argentina
Centro Oncologico Tres Arroyos
🇦🇷Tres Arroyos, Argentina
Unidad Oncologica Del Neuquen
🇦🇷Neuquen, Argentina
Grupo Oncologico Cooperativo del Sur
🇦🇷Bahia Blanca, Buenos Aires, Argentina
Policlinica Privada Instituto De Medicina Nuclear
🇦🇷Bahia Blanca, Buenos Aires, Argentina
St. Joseph Medical Center
🇦🇷Gonnet, Buenos Aires, Argentina
Centro Medico Nacional de Occidente
🇲🇽Guadalajara, Jalisco, Mexico
Sanatorio Santa Rosa S.R.L.
🇦🇷Santa Rosa, La Pampa, Argentina