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Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer Clinical Trials Information presented on Clinical Trials Search isn't intended to be a substitute for proven healthcare advice, trips or treatment using a real physician. We are not docs. Always confer with your mD on Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer Clinical research trials and Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer medical trials take place in hundreds of localities across the U.S.. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials usually measure the effectiveness of new drugs. The intention of the studies / projects is to resolve certain human health questions. Clinical trials are a popular means for physicians, government agencies, and private sector corporations to detect remedies for all forms of circumstances, like Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer. Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer Clinical Trials and other clinical trials allow for volunteers to undergo healthcare treatment options before they are available to the masses. Most times the participants receive treatment for free, and every now and again they are paid for their time. Occasionally there is a cost for a Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer clinical trial. Subjects typically recieve the finest healthcare available for their Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer condition. Hazards are a reality, nonetheless, and might include more or frequent mD trips, health risks (potentially life-endangering), and/or the treatment being ineffective. Trials are federally regulated with stern guidelines to protect clinical trials subjects.
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Home > "D" Clinical Trials Conditions > Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer  Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
For Condition: stage 3A breast cancer,Male Breast Cancer,stage 3B breast cancer,stage 4 breast cancer,stage 3C breast cancer
Status: Recruiting
Sponsor(s): Ireland Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells. PURPOSE: Randomizedphase II trial to study the effectiveness of docetaxel with or without bevacizumab followed by surgery, radiation therapy, and combination chemotherapy in treating patients who have stage III or stage IV breast cancer.
Details: OBJECTIVES: - Determine the effect of bevacizumab and docetaxel on reduction of microvessel density and induction of apoptosis of endothelial and tumor cells in patients with locally advanced breast cancer. - Determine the safety profile of this regimen in these patients. - Compare the effect of docetaxel and bevacizumab, in terms of objective response, stabilization of disease, and progression-free survival, in these patients. OUTLINE: This is a randomized study. Patients are stratified according to disease stage. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive docetaxel IV over 1 hour once weekly on weeks 1-6 and bevacizumab IV over 60 minutes once every 2 weeks on weeks 1-8. - Arm II: Patients receive docetaxel as in arm I. Treatment in both arms repeats every 8 weeks for 2 courses in the absence of disease progression or unacceptable toxicity. After the second course, patients with stable or responsive disease undergo modified radical mastectomy or breast-conserving surgery. Three to six weeks after surgery, patients undergo radiotherapy 5 days a week for 7 weeks. Approximately 4 weeks after the completion of radiotherapy, patients receive doxorubicin IV over 5 minutes and cyclophosphamide IV over 30-60 minutes on day 1. Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with estrogen and/or progesterone receptor positive disease also receive oral tamoxifen daily for 5 years beginning after the completion of chemotherapy. Patients are followed at 3, 6, and 12 months, every 6 months for 4 years, and then annually thereafter. PROJECTED ACCRUAL: A total of 60 patients (30 per treatment arm) will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Stage IIIA or IIIB - Stage IV if patient has clinical evidence of locally advanced breast cancer only - Inoperable disease - Prior carcinoma in situ of the breast or bilateral breast cancer is allowed - No CNS metastases - Hormone receptor status: - Estrogen and progesterone receptor status known PATIENT CHARACTERISTICS: Age: - 18 and over Sex: - Female or male Menopausal status: - Not specified Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: - More than 6 months Hematopoietic: - WBC at least 3,000/mm^3 - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin normal (no greater than 2 times upper limit of normal [ULN] in patients with an inherited disorder) - AST/ALT no greater than 2.5 times ULN - INR and PTT normal Renal: - Creatinine normal OR - Creatinine clearance at least 60 mL/min - No proteinuria or clinically significant renal impairment Cardiovascular: - LVEF at least 45% by echocardiogram or MUGA scan - No New York Heart Association class III or IV heart disease - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No inadequately controlled hypertension - No history of deep vein thrombosis or other thromboses Other: - No other prior or concurrent malignancy within the past 10 years except inactive nonmelanoma skin cancer or carcinoma in situ of the cervix - No other uncontrolled concurrent illness - No ongoing or active infection - No non-healing wounds - No psychiatric illness or social situation that would preclude study entry - No prior allergic reaction to compounds of similar chemical or biological composition to bevacizumab, docetaxel, polysorbate 80 (Tween) formulations, or other agents used in this study - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective barrier contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - No concurrent cytokines during docetaxel/bevacizumab administration - Concurrent cytokines during doxorubicin/cyclophosphamide administration allowed at the discretion of the treating physician Chemotherapy: - No prior chemotherapy Endocrine therapy: - Prior hormonal therapy (e.g., tamoxifen) allowed Radiotherapy: - Prior radiotherapy to affected breast allowed Surgery: - More than 28 days since prior major surgery Other: - At least 10 days since prior thrombolytic agents - At least 10 days since prior full-dose oral or parenteral anticoagulants except to maintain patency of permanent indwelling IV catheters - No other concurrent investigational agents - No concurrent combination antiretroviral therapy for HIV-positive patients - No concurrent full-dose oral or parenteral anticoagulants except to maintain patency of permanent indwelling IV catheters - No concurrent thrombolytic agents - No other concurrent anticancer agents or therapies - Concurrent warfarin allowed if INR less than 1.5 - Concurrent bisphosphonates allowed in patients with osseous metastases, but may not be initiated on day 1
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BethOvermoyer, Study Chair, Ireland Cancer Center
Ireland Cancer Center *Recruiting*
Cleveland, Ohio, 44106-5055
United States
Recruiting Beth Overmoyer 216-844-3862
Additional Information:
Study ID Numbers: CDR0000069090; NCI-2722,CWRU-3100
Study Start Date:
Record last reviewed: August 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00027885
Other Stage 3a Breast Cancer Studies:
1. Magnetic Resonance Imaging in Women Receiving Chemotherapy for Stage III Breast Cancer
2. Trastuzumab and Exemestane in Treating Postmenopausal Women With Metastatic or Locally Advanced Breast Cancer
3. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
4. Capecitabine in Treating Women With Advanced or Metastatic Breast Cancer
5. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
Related Studies:
Other stage 3A breast cancer Clinical Trials
Other Ohio Clinical Trials
Other Cleveland Clinical Trials
Docetaxel With or Without Bevacizumab Followed by Surgery, Radiation Therapy, and Combination Chemotherapy in Treating Patients With Locally Advanced Breast Cancer
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