|
Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer Clinical Trials Resources presented on Clinical Trials Search isn't meant to be a substitute for qualified health advice, visits or professional assistance with a real medical. We aren't doctors. Always consult your mD about Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer Clinical research trials and Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer health trials occur in a lot of of places throughout the United States of America. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials typically assess the effectivity of new does drugs. The role of the studies / projects is to resolve certain human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector corporations to detect remedies for all varieties of circumstances, such as Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer. Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain health treatment choices before they are available to the general public. Most times the human subjects recieve professional assistance for free of charge, and every now and again they are paid for their time. Sometimes there is a cost for a Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer clinical trial. Human subjects frequently get the finest healthcare available for their Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer condition. Risks are a reality, however, and may include extra or frequent physician visits, medical dangers (possibly life-threatening), and/or the treatment being uneffective. Trials are federally governed with strict guidelines to protect clinical trials patients.
|
|
|
|
|
|
|
Home > "D" Clinical Trials Conditions > Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer  Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer
Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer
For Condition: stage 3B breast cancer,stage 3A breast cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Robert H. Lurie Cancer Center
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 drug may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining docetaxel, doxorubicin, and cyclophosphamide in treating women who have previously untreated stage III breast cancer.
Details: OBJECTIVES: I. Determine the clinical response rate to docetaxel, doxorubicin, and cyclophosphamide as primary therapy in women with stage III breast cancer. II. Determine the pathologic complete response rate to this treatment regimen in this patient population. III. Assess the side effects and toxicity profile of this treatment regimen in these patients. PROTOCOL OUTLINE: This is an open label, multicenter study. Patients receive doxorubicin IV over 5-10 minutes followed by cyclophosphamide IV over 5-10 minutes and docetaxel IV over 1 hour. Treatment repeats every 3 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Within 5 weeks following completion of chemotherapy, operable patients achieving complete or partial response undergo mastectomy, segmental mastectomy, or lumpectomy with nodal dissection. Patients with positive surgical tumor margins may undergo an additional surgical procedure. Patients are followed for survival. PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study within 1 year.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically or cytologically confirmed previously untreated, stage III adenocarcinoma of the breast - At least one bidimensionally and/or unidimensionally measurable lesion - No evidence of disease outside the breast or chest wall, except for ipsilateral axillary lymph nodes - Hormone receptor status: Not specified --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy for breast cancer - Chemotherapy: No prior chemotherapy for breast cancer - Endocrine therapy: No prior hormonal therapy for breast cancer; No concurrent corticosteroids except for chronic methylprednisolone or equivalent for more than 6 months duration at no more than 20 mg/day - Radiotherapy: Not specified - Surgery: Not specified - Other: At least 3 weeks since prior investigational drugs --Patient Characteristics-- - Age: 18 and over - Sex: Female - Menopausal status: Not specified - Performance status: Karnofsky 60-100% - Life expectancy: Not specified - Hematopoietic: Neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - Hepatic: Bilirubin no greater than upper limit of normal (ULN); SGOT no greater than 3 times ULN; Alkaline phosphatase no greater than 5 times ULN; No acute hepatitis - Renal: Creatinine no greater than 1.5 mg/dL; No uncontrolled hypercalcemia - Cardiovascular: No congestive heart failure; LVEF normal; No angina pectoris; No uncontrolled cardiac arrhythmias; No other significant heart disease; No myocardial infarction within the past year; No superior vena cava syndrome; No deep vein thrombosis requiring anticoagulant therapy - Neurologic: No dementia; No seizures; No concurrent grade 2 or greater peripheral neuropathy - Other: No medical instability; No active infection; No gastrointestinal bleeding; No uncontrolled diabetes; No psychological, familial, sociological, or geographical conditions or other circumstances that would preclude study; No other malignancy within the past 5 years except curatively treated basal cell skin cancer or carcinoma in situ of the cervix; No history of hypersensitivity to polysorbate 80; Not pregnant or nursing; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
WilliamGradishar, Study Chair, Robert H. Lurie Cancer Center
Stanford University Medical Center
Stanford, California, 94305-5408
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Monroe Medical Associates
Chicago, Illinois, 60603
United States
Additional Information:
Study ID Numbers: CDR0000067423; NU-98B1,NCI-G99-1643
Study Start Date: October 1999
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00004175
Other Stage 3a Breast Cancer Studies:
1. Combination Chemotherapy Followed by Radiation Therapy With or Without Surgery in Treating Women With Locally Advanced or Inflammatory Breast Cancer
2. Vaccine Therapy in Treating Patients With Breast Cancer
3. Paclitaxel With or Without Trastuzumab in Treating Patients With Inoperable, Recurrent, or Metastatic Breast Cancer
4. Adjuvant Chemotherapy in Treating Women Who Have Undergone Resection for Relapsed Breast Cancer
5. Suramin and Paclitaxel in Treating Women With Stage IIIB or Stage IV Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other New York Clinical Trials
Other Bronx Clinical Trials
Docetaxel, Doxorubicin, and Cyclophosphamide in Treating Women With Stage III Breast Cancer
|
|
|
|
|
|
|
|
