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Home > "D" Clinical Trials Conditions > Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer  Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: Recruiting
Sponsor(s): Grupo Oncologico Cooperativo del Sur ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 21 Years/75 Years
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BernardoLeone, Study Chair, Unidad Oncologica Del Neuquen
Centro Medico Nacional de Occidente *Recruiting*
Guadalajara, Jalisco, 4430
Mexico
Recruiting Gilberto Villela 523-641-5081
Policlinica Privada Instituto De Medicina Nuclear *Recruiting*
Bahia Blanca, Buenos Aires, 8000
Argentina
Recruiting Alberto Romero 54-291-453-9848
Grupo Oncologico Cooperativo del Sur *Recruiting*
Bahia Blanca, Buenos Aires, 8000
Argentina
Recruiting Juan Perez 54-291-452-5667
St. Joseph Health Center *Recruiting*
Gonnet, Buenos Aires, 1987 MB
Argentina
Recruiting Sergio Grasso 54-221-4845088
Sanatorio Santa Rosa S.R.L. *Recruiting*
Santa Rosa, La Pampa, 6300
Argentina
Recruiting Eduardo Ortiz 0954-29715
Unidad Oncologica Del Neuquen *Recruiting*
Neuquen, ,
Argentina
Recruiting Bernardo Leone 54-299-4485247
Centro Oncologico Tres Arroyos *Recruiting*
Tres Arroyos, , 7500
Argentina
Recruiting Maria Dominguez 0983-33450
C.O.P.M.P. *Recruiting*
Mar del Plata, , 7600
Argentina
Recruiting Ricardo Rodriguez 542-234-793-283
Additional Information:
Study ID Numbers: CDR0000068969; NCI-V01-1670,GOCS-02-BR-01
Study Start Date:
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00026078
Other Stage 4 Breast Cancer Studies:
1. Combination Chemotherapy in Treating Women With Breast Cancer That is Metastatic or Cannot be Treated With Surgery
2. Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer
3. Trastuzumab and Flavopiridol in Treating Patients With Metastatic Breast Cancer
4. T-Cell-Depleted Allogeneic Stem Cell Transplantation Followed By Donor Lymphocytes Given After Induction Chemotherapy and Reduced-Intensity Transplantation Conditioning in Treating Patients With Metastatic Breast Cancer
5. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Jalisco Clinical Trials
Other Guadalajara Clinical Trials
Docetaxel and Ifosfamide in Treating Women With Metastatic Breast Cancer
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