|
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer Clinical research trials and Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer medical trials occur in many of places across the U.S.A.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
|
|
|
|
|
|
|
Home > "C" Clinical Trials Conditions > Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer  Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): GERCOR ,
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy in treating older women who have metastatic breast cancer.
Details: OBJECTIVES: - Determine the survival without degradation of quality of life in elderly women with metastatic breast cancer treated with leucovorin calcium, fluorouracil, and mitoxantrone. - Determine the efficacy of this regimen, in terms of response and survival without progression, in these patients. - Determine the tolerance of these patients to this regimen. OUTLINE: This is a multicenter study. Patients receive mitoxantrone IV and leucovorin calcium IV over 2 hours on day 1. Patients then receive fluorouracil IV over 46 hours on days 1-2. Treatment repeats every 21 days for a maximum of 8 courses in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline, after 3 courses, and at treatment completion. Patients are followed every 3 months. PROJECTED ACCRUAL: A total of 39 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 75 Years/90 Years
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed metastatic adenocarcinoma of the breast - Bidimensionally measurable or evaluable disease - At least one non-irradiated lesion that is at least 2 cm in the greater diameter OR - Serous drainage, cutaneous metastasis, osseous metastasis, etc. - No symptomatic cerebral metastasis - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age: - 75 to 90 Sex: - Female Menopausal status: - Postmenopausal Performance status: - WHO 0-2 Life expectancy: - At least 3 months Hematopoietic: - Platelet count at least 100,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 Hepatic: - Alkaline phosphatase less than 3 times normal - Bilirubin less than 1.5 times normal - Transaminases less than 3 times normal - Total protein greater than 60% - Albumin greater than 30 g/L Renal: - Creatinine clearance greater than 60 mL/min Cardiovascular: - LVEF greater than 50% by echocardiogram or scintigraph - ECG normal - No uncontrolled angina - No myocardial infarction within past 6 months Other: - No other medical illness or condition that would preclude study - No other prior malignancy except basal cell skin cancer or curatively treated carcinoma in situ of the cervix - No psychological, social, familial, or geographical reasons that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: - Not specified Chemotherapy: - Prior adjuvant chemotherapy allowed - No prior adjuvant anthracyclines - No prior chemotherapy for metastatic disease Endocrine therapy: - One or two prior regimens of hormonal therapy allowed for metastatic disease Radiotherapy: - No prior radiotherapy for metastatic disease Surgery: - Not specified Other: - No concurrent participation in another study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
E.Carola, Study Chair, C.H. Senlis
Hopital Tenon
Paris, , 75970
France
Centre Hospitalier Victor Dupouy
Argenteuil, , 95107
France
Polyclinique De Courlancy
Metz, , 55038
France
Hopital Saint Antoine
Paris, , 75571
France
Centre Medico-Chirurgical Foch
Suresnes, , 92151
France
C.H. Senlis
Senlis, , 60309
France
Additional Information:
Study ID Numbers: CDR0000068439; EU-20028,FRE-GERCOR-SAM-S99-1
Study Start Date:
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00010075
Other Recurrent Breast Cancer Studies:
1. Vinorelbine Plus Fluorouracil in Treating Women With Metastatic Breast Cancer
2. SU5416 and Doxorubicin in Treating Patients With Stage IIIB or Stage IV Inflammatory Breast Cancer
3. Drug Resistance Inhibition in Treating Patients With Recurrent or Metastatic Breast Cancer
4. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
5. Gefitinib in Treating Patients With Metastatic Breast Cancer That Has Progressed After Antiestrogen and Nonsteroidal Aromatase Inhibitor Therapy
Related Studies:
Other recurrent breast cancer Clinical Trials
Other Clinical Trials
Other Argenteuil Clinical Trials
Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
|
|
|
|
|
|
|
|
