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Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer Clinical research trials and Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer. Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer clinical trial. Human subjects often get the best healthcare possible for their Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer  Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer
Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer
For Condition: recurrent breast cancer,stage 4 breast cancer,Male Breast Cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Dana-Farber/Harvard Cancer Center
Synopsis: RATIONALE: Monoclonal antibodies such as bevacizumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining monoclonal antibody with chemotherapy may kill more cancer cells. PURPOSE: Phase II trial to study the effectiveness of bevacizumab combined with vinorelbine in treating patients who have stage IV breast cancer.
Details: OBJECTIVES: I. Determine the complete and partial response rates in patients with stage IV breast cancer treated with concurrent bevacizumab and vinorelbine. II. Determine the side effects of this regimen in these patients. III. Determine the time to disease progression in patients treated with this regimen. IV. Determine the time on study (a reflection of time to progression, treatment-related side effects, and patient preference) of patients treated with this regimen. V. Assess urine protein/creatinine ratio and serum complement levels as screening measures for renal injury in patients treated with bevacizumab. PROTOCOL OUTLINE: This is a multicenter study. Patients receive bevacizumab IV over 30-90 minutes once every other week and vinorelbine IV over 6-10 minutes once weekly for 8 weeks. Treatment repeats every 8 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Patients with complete or partial response or stable disease after completion of the fourth course may receive additional courses of concurrent bevacizumab and vinorelbine administered once every other week or may continue therapy on the schedule as above. PROJECTED ACCRUAL: A total of 56 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 stage IV breast cancer - Patients without pathologic or cytologic confirmation of metastatic disease must have unequivocal evidence of metastasis by physical exam or radiologic study Must meet 1 of the following criteria: - Received 1 or 2 prior conventional chemotherapy regimens for metastatic disease - Relapsed within 1 year after adjuvant chemotherapy and no prior chemotherapy for metastatic disease At least 1 unidimensionally measurable lesion, meeting 1 of the following criteria: - At least 20 mm by conventional techniques - At least 10 mm by spiral CT scan No CNS metastases by CT scan or MRI within the past 6 weeks No prior or concurrent primary CNS tumor on physical exam Disease progression after bone marrow or peripheral blood stem cell transplantation allowed HER2-positive tumors allowed if previously treated with trastuzumab (Herceptin) Hormone receptor status: Not specified --Prior/Concurrent Therapy-- Biologic therapy: - See Disease Characteristics - No prior bevacizumab - No other prior experimental angiogenesis inhibitors - At least 2 weeks since prior trastuzumab and recovered - Concurrent epoetin alfa or filgrastim (G-CSF) allowed Chemotherapy: - See Disease Characteristics - At least 2 weeks since prior chemotherapy and recovered - No prior vinorelbine - No more than 2 prior conventional chemotherapy regimens for metastatic breast cancer Endocrine therapy: Prior hormonal therapy allowed Radiotherapy: - At least 1 week since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - At least 4 weeks since prior major surgical procedure or open biopsy - At least 1 week since prior fine-needle aspiration except in the breast - No concurrent major surgical procedure Other: - Recovered from the toxic effects of any prior therapy - At least 10 days since prior oral or parenteral anticoagulants (e.g., heparin or warfarin) except to maintain the patency of permanent, indwelling central venous catheter - At least 10 days since prior thrombolytic agents - No chronic aspirin therapy greater than 325 mg per day or nonsteroidal anti-inflammatory medications that inhibit platelet function - No concurrent COX-2 inhibitors that inhibit platelet function - No other concurrent investigational or commercial agents or therapies for the malignancy - No concurrent antiretroviral therapy for HIV-positive patients - No concurrent ketoconazole, zidovudine, or macrolide antibiotics - No concurrent oral or parenteral anticoagulants except to maintain patency of permanent, indwelling central venous catheter - No concurrent thrombolytic agent - Concurrent bisphosphonates allowed - Concurrent celecoxib or rofecoxib allowed --Patient Characteristics-- Age: 18 and over Sex: Male or female Menopausal status: Not specified Performance status: - ECOG 0-2 OR - Karnofsky 60-100% Life expectancy: More than 3 months Hematopoietic: - Absolute neutrophil count at least 1,500/mm3 - Hemoglobin at least 9 g/dL - Platelet count at least 100,000/mm3 - No prior bleeding diathesis or coagulopathy Hepatic: - Bilirubin no greater than 1.5 times upper limit of normal (ULN) - AST/ALT no greater than 2.5 times ULN - INR no greater than 1.5 Renal: - Creatinine less than 2 mg/dL - Urine protein no greater than +1 by dipstick OR - Urine protein less than 500 mg by 24-hour urine collection Cardiovascular: - LVEF at least 50% - No significant cardiovascular disease (e.g., uncontrolled hypertension, myocardial infarction, or unstable angina pectoris) - No New York Heart Association class II-IV congestive heart failure - No serious cardiac arrhythmia requiring medication, including atrial fibrillation requiring systemic anticoagulation - No grade II or greater peripheral vascular disease within the past year - No deep vein thrombosis or embolism within the past 5 years - No prior stroke Other: - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No evidence of seizures not controlled with standard medical therapy - No prior allergic reactions attributed to compounds of similar chemical or biologic composition to bevacizumab or other agents used in the study - Prior mild infusion reaction to trastuzumab allowed - No serious nonhealing wound, ulcer, or bone fracture - No significant traumatic injury within the past 4 weeks - No other concurrent illness (such as active infection) that would require active treatment or preclude study - No psychiatric illness or social situation that would preclude study
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HaroldBurstein, Study Chair, Dana-Farber/Harvard Cancer Center
Dana-Farber Cancer Institute
Boston, Massachusetts, 02115
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
Additional Information:
Study ID Numbers: CDR0000068685; NCI-2716,DFCI-01013
Study Start Date: March 2001
Record last reviewed: June 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017394
Other Stage 4 Breast Cancer Studies:
1. Liposomal Doxorubicin and Trastuzumab in Treating Women With Advanced Breast Cancer
2. Combination Chemotherapy in Treating Older Women With Metastatic Breast Cancer
3. Marimastat or No Further Therapy in Treating Women With Metastatic Breast Cancer That Is Responding or Stable Following Chemotherapy
4. ICI 182780 in Treating Women With Metastatic Breast Cancer
5. Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Bevacizumab Plus Vinorelbine in Treating Patients With Stage IV Breast Cancer
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