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Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer Clinical research trials and Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer. Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer clinical trial. Human subjects often get the best healthcare available for their Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "C" Clinical Trials Conditions > Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer  Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
For Condition: stage 3A breast cancer,stage 3B breast cancer,stage 2 breast cancer,stage 4 breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Beckman Research Institute
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. Amifostine may protect normal cells from the side effects of chemotherapy. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, amifostine, and peripheral stem cell transplantation in treating patients who have stage II, stage III, or stage IV breast cancer.
Details: OBJECTIVES: I. Evaluate the feasibility of high dose doxorubicin, cyclophosphamide, paclitaxel, and amifostine in patients with high risk stage II/III and responsive stage IV advanced breast cancer. II. Determine the pharmacokinetic profile of paclitaxel administered with amifostine in this regimen in these patients. III. Assess the toxicity of this treatment regimen in this patient population. PROTOCOL OUTLINE: Patients receive filgrastim (G-CSF) subcutaneously twice daily on days 1-4 for peripheral blood stem cell (PBSC) mobilization and continuing through days 5-10 during PBSC collection. At least 2 weeks following mobilization, patients receive doxorubicin IV as a continuous infusion on days -9 through -5 followed by cyclophosphamide IV over 2 hours on day -5 and amifostine IV over 15 minutes, and paclitaxel IV over 24 hours on day -4. On day -2, 25% PBSC are reinfused and 75% are reinfused on day 0, followed by daily G-CSF subcutaneously or IV beginning on day 1. Patients are followed every 3 months for 2 years, then periodically thereafter. PROJECTED ACCRUAL: A total of 15 patients will be accrued for this study within 6-8 months.
Eligibility:
Study Type: Interventional, Educational/Counseling/Training
Minimum Age/Maximum Age: /59 Years
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven breast cancer including: Stage IV metastatic disease with current partial or complete response to prior induction chemotherapy; High risk primary disease with less than 60% chance of progression free survival at 3 years; Stage II tumors with 10 or more axillary node involvement; Stage IIIA or IIIB tumors - No bone marrow metastases - No CNS metastases - No more than 10 bone metastases - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: Not specified - Chemotherapy: See Disease Characteristics; At least 4 weeks since prior chemotherapy; No more than 2 prior chemotherapy regimens for metastatic disease; Prior total doxorubicin dose no greater than 180 mg/m2; Prior total paclitaxel dose no greater than 750 mg/m2 - Endocrine therapy: At least 4 weeks since prior hormonal therapy - Radiotherapy: At least 4 weeks since prior radiotherapy; No prior radiotherapy to the left chest wall; No prior radiotherapy to greater than 20% of bone marrow (excluding syngeneic transplantation candidates) - Surgery: Not specified --Patient Characteristics-- - Age: 59 and under - Menopausal status: Not specified - Performance status: Karnofsky 80-100% - Life expectancy: Not specified - Hematopoietic: Neutrophil count greater than 2,000/mm3; Platelet count greater than 150,000/mm3; Hemoglobin greater than 9 g/dL (blood transfusions allowed) - Hepatic: Bilirubin no greater than 1.2 mg/dL; SGOT or SGPT less than 1.5 times upper limit of normal - Renal: Creatinine no greater than 1.2 mg/dL; Creatinine clearance at least 80 mL/min; No prior hemorrhagic cystitis - Cardiovascular: Ejection fraction at least 55% by MUGA; No prior valvular heart disease or arrhythmia - Pulmonary: DLCO at least 60% lower limit of predicted; pCO2 no greater than 43 mmHg on room air; pO2 greater than 85 mmHg on room air; FEV 1 at least 2 liters - Other: No other prior malignancy except basal or squamous cell skin cancer, or carcinoma in situ or stage I carcinoma of the cervix; Not pregnant; HIV negative; Hepatitis B negative; No prior history of disabling psychosocial disorder; No other CNS dysfunction
Total Enrollment:
Location and Contact Information:
Overall Study Official:
GeorgeSomlo, Study Chair, Beckman Research Institute
Cancer Center and Beckman Research Institute, City of Hope
Duarte, California, 91010-3000
United States
Additional Information:
Study ID Numbers: CDR0000067115; CHNMC-IRB-99002,NCI-G99-1527,ALZA-CHNMC-IRB-99002
Study Start Date: March 1999
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00003927
Other Stage 3b Breast Cancer Studies:
1. Radiation Therapy After Surgery in Treating Women With Early Stage Breast Cancer
2. Epirubicin, Docetaxel, and Pegfilgrastim in Treating Women With Locally Advanced or Inflammatory Breast Cancer
3. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
4. Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
5. Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer
Related Studies:
Other stage 3B breast cancer Clinical Trials
Other California Clinical Trials
Other Duarte Clinical Trials
Combination Chemotherapy, Amifostine, and Peripheral Stem Cell Transplantation in Treating Patients With Stage II, Stage III, or Stage IV Breast Cancer
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