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Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for certified medical advice, calls or professional assistance using a genuine dr.. We aren't physicians. Always confer with your dr. on Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer Clinical research trials and Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer medical trials happen in hundreds of localities throughout 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 typically measure the effectualness of new does drugs. The intent of the studies / undertakings is to answer particular human health questions. Clinical trials are a popular manner for physicians, government agencies, and private sector corporations to find cures for all kinds of circumstances, like Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer. Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer Clinical Trials and other clinical trials permit volunteers to acquire healthcare treatment options before they are available to the general public. Some times the subjects acquire professional assistance for free, and sometimes they are paid for their time. Sometimes there is a cost for a Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer condition. Dangers are a reality, nevertheless, and can include more or frequent doctor calls, health risks (potentially life-jeopardizing), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "C" Clinical Trials Conditions > Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer  Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer
Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Herbert Irving Comprehensive Cancer Center
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known if chemotherapy followed by peripheral stem cell transplantation is more effective than chemotherapy alone in treating metastatic breast cancer. PURPOSE: Randomized phase II trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation with that of chemotherapy alone in treating women who have stage IV breast cancer.
Details: OBJECTIVES: I. Compare the efficacy of multi-course high-dose chemotherapy with autologous peripheral blood stem cell transplantation versus standard-dose chemotherapy in women with metastatic breast cancer. II. Compare the five year event-free survival, in terms of time to progression or time to death due to toxic effects, in patients treated with these regimens. III. Compare the response rate and overall survival of patients treated with these regimens. IV. Compare the toxicity of these regimens in this patient population. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two treatment arms. Arm I: Patients receive docetaxel and doxorubicin once followed by filgrastim (G-CSF) daily for approximately 1 week. Treatment repeats approximately every 3 weeks for 4 courses. Patients then receive cyclophosphamide, methotrexate, and fluorouracil on days 7 and 8 every 4 weeks for 4 courses. Arm II: Patients receive docetaxel, doxorubicin, and G-CSF as in arm I for 3 courses. Patients undergo leukapheresis daily for 3 or 4 days. Patients then receive 1 course of ifosfamide, etoposide, and carboplatin daily for 4 days when blood counts recover, followed by 1 course of cyclophosphamide and thiotepa daily for 4 days. Patients undergo peripheral blood stem cell reinfusion following each course. PROJECTED ACCRUAL: A total of 264 patients (132 per arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/59 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically confirmed stage IV breast carcinoma - Bone metastasis as only form of metastatic disease allowed - No evidence of bone marrow involvement by aspirate or biopsy - No brain metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: No prior chemotherapy for metastatic disease; No prior mitomycin, nitrosoureas, or platinum coordination complexes; Prior adjuvant chemotherapy allowed if completed more than 6 months prior to relapse with metastases; No more than 300 mg/m2 prior doxorubicin or 450 mg/m2 prior epirubicin - Endocrine therapy: Not specified - Radiotherapy: No prior radiotherapy to the brain or marrow-bearing pelvis; Prior radiotherapy to lower pelvis allowed if the upper border of the radiotherapy field is below the upper border of the acetabulum; No other prior radiotherapy to the pelvis - Surgery: At least 2 weeks since prior major surgery - Other: No other concurrent anti-cancer therapy --Patient Characteristics-- - Age: 18 to 59 - Sex: Female - Menopausal status: Not specified - Performance status: Karnofsky 80-100% - Life expectancy: More than 3 months - Hematopoietic: Absolute neutrophil count greater than 1,500/mm3; Platelet count greater than 100,000/mm3; Hemoglobin greater than 9 g/dL; PT normal; Activated PTT normal - Hepatic: Bilirubin normal (unless benign congenital hyperbilirubinemia is present); No AST/ALT greater than 1.5 times upper limit of normal (ULN) together with alkaline phosphatase greater than 2.5 times ULN; No active hepatitis B or C - Renal: Creatinine normal - Cardiovascular: Ejection fraction normal by MUGA or echocardiogram; No active heart disease; No prior myocardial infarction or other manifestation of coronary artery disease - Other: More than 1,000 calories/day oral intake; HIV negative; No active serious medical or psychiatric disease; No other prior or concurrent malignancy except basal cell skin cancer or carcinoma in situ of the cervix; No allergy to polysorbate 80 or E. coli-derived products; No peripheral neuropathy greater than grade 2; Not pregnant; Negative pregnancy test
Total Enrollment:
Location and Contact Information:
Overall Study Official:
LindaVahdat, Study Chair, Herbert Irving Comprehensive Cancer Center
Herbert Irving Comprehensive Cancer Center
New York City, New York, 10032
United States
Additional Information:
Study ID Numbers: CDR0000068504; NCI-G01-1922,CPMC-IRB-9244
Study Start Date: January 2000
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00012311
Other Stage 4 Breast Cancer Studies:
1. Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer
2. Combination Chemotherapy Followed By Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer
3. Fluorouracil-Uracil and Leucovorin in Treating Women With Metastatic Breast Cancer
4. Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
5. Arsenic Trioxide in Treating Women With Locally Advanced or Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other New York Clinical Trials
Other New York City Clinical Trials
Chemotherapy Plus Peripheral Stem Cell Transplantation Compared With Chemotherapy Alone in Treating Women With Stage IV Breast Cancer
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