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Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic 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 Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer Clinical research trials and Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic 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 Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer. Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic 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 Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer clinical trial. Participants frequently obtain the most expert healthcare available for their Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic 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 > "B" Clinical Trials Conditions > Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer  Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: No longer recruiting
Sponsor(s): Arthur G. James Cancer Hospital & Richard J. Solove Research Institute , 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: Phase II trial to study the effectiveness of combining bevacizumab with docetaxel in treating women who have locally advanced or metastatic breast cancer.
Details: OBJECTIVES: - Determine the response rate in women with locally advanced or metastatic breast cancer treated with bevacizumab and docetaxel. - Determine the side effects of this regimen in these patients. - Correlate soluble activated endothelial cell markers and adhesion molecules, quantitation of tumor and/or endothelial cell apoptosis, and quantitation of microvessel density with clinical outcome in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes on weeks 1 and 3 and docetaxel IV over 60 minutes on weeks 1, 2, and 3. Treatment repeats every 4 weeks for up to 12 courses in the absence of unacceptable toxicity or disease progression. After completion of 6 courses of combined treatment, patients with an ongoing response may receive bevacizumab alone in the absence of disease progression. PROJECTED ACCRUAL: A total of 16-27 patients will be accrued for this study within 14-27 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed breast cancer - Local-regional recurrences or metastatic disease - At least 1 unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - No history or evidence of CNS disease (e.g., primary brain tumor or any brain metastases) - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy - More than 3 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 - No bleeding diathesis or coagulopathy Hepatic - Bilirubin normal - AST/ALT no greater than 2.5 times upper limit of normal - INR less than 1.5 (patients receiving warfarin) Renal - Creatinine normal OR - Creatinine clearance at least 60 mL/min - No baseline proteinuria - Patients with proteinuria of 1+ or greater at baseline are allowed provided 24-hour urinary protein is less than 500 mg Cardiovascular - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia - No uncontrolled hypertension - No history of stroke Other - HIV negative - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No seizures not controlled with standard medical therapy - No prior allergic reactions attributed to compounds of similar chemical or biological composition to study agents - No psychiatric illness or social situation that would preclude study compliance - No ongoing or active infection - No other concurrent uncontrolled illness - No non-healing wounds - No significant traumatic injury within the past 28 days PRIOR CONCURRENT THERAPY: Biologic therapy - Not specified Chemotherapy - Prior adjuvant chemotherapy allowed (up to 1 regimen for metastatic disease) - More than 6 months since prior taxane-containing adjuvant chemotherapy - More than 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitocycin) and recovered Endocrine therapy - Not specified Radiotherapy - More than 3 weeks since prior radiotherapy Surgery - More than 28 days since prior major surgery or open biopsy - More than 7 days since prior fine needle aspirations other than in the breast - More than 7 days since prior placement of a vascular access device - No concurrent major surgical procedure Other - No concurrent or recent full-dose oral or parenteral anticoagulants or thrombolytic agents (except as required to maintain patency of preexisting, permanent indwelling IV catheters) - No other concurrent investigational agents - No concurrent chronic daily aspirin (more than 325 mg/day) or nonsteroidal anti-inflammatory medications (known to inhibit platelet function at doses used to treat chronic inflammatory diseases)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
CharlesShapiro, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora, Colorado, 80010
United States
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
Additional Information:
Study ID Numbers: CDR0000271359; NCI-2715,UCHSC-01239,OSU-NCI-2715
Study Start Date:
Record last reviewed: May 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00055861
Other Recurrent Breast Cancer Studies:
1. Peripheral Stem Cell Transplantation in Treating Patients With Melanoma or Small Cell Lung, Breast, Testicular, or Kidney Cancer That is Metastatic or That Cannot Be Treated With Surgery
2. Docetaxel, Vinorelbine, and Filgrastim in Treating Women With Stage IV Breast Cancer
3. Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
4. Vaccine Therapy in Treating Patients With Metastatic or Recurrent Cancer
5. Irinotecan and Capecitabine in Treating Women With Advanced Breast Cancer
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Bevacizumab and Docetaxel in Treating Women With Locally Advanced or Metastatic Breast Cancer
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