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Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or treatment with a real dr.. We aren't doctors. Always consult your mD on Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer Clinical research trials and Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer medical trials occur in many of places across 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 generally assess the effectiveness of new does drugs. The role of the studies / undertakings is to figure out certain human healthcare questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to locate treatments for all forms of circumstances, including Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer. Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer Clinical Trials and other clinical trials permit volunteers to get medical treatment options before they are available to the masses. Most times the human subjects acquire treatment for free of charge, and sometimes they are paid for their time. Occasionally there is a cost for a Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer clinical trial. Participants oftentimes recieve the finest healthcare available for their Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer condition. Dangers are a reality, nonetheless, and might include extra or frequent physician calls, health hazards (potentially life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials subjects.
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Home > "M" Clinical Trials Conditions > Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer  Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
For Condition: stage 4 breast cancer,recurrent breast cancer
Status: Recruiting
Sponsor(s): Dana-Farber/Harvard Cancer Center , National Cancer Institute (NCI)
Synopsis: RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide and methotrexate, work in different ways to stop tumor cells from dividing so they stop growing or die. Bevacizumab may stop the growth of cancer by stopping blood flow to the tumor. Combining metronomic (regularly timed) low-dose cyclophosphamide and methotrexate with bevacizumab may kill more tumor cells. PURPOSE: Randomizedphase II trial to compare the effectiveness of combining metronomic low-dose cyclophosphamide and methotrexate with or without bevacizumab in treating women who have metastatic breast cancer.
Details: OBJECTIVES: Primary - Compare the overall response rate in women with metastatic breast cancer treated with metronomic low-dose cyclophosphamide and methotrexate with or without bevacizumab. Secondary - Compare the progression-free survival of patients treated with these regimens. - Compare the toxicity of these regimens in these patients. - Correlate markers of angiogenesis, including vascular endothelial growth factor and circulating endothelial cells, at baseline and during treatment, with response in patients treated with these regimens. OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive low-dose oral cyclophosphamide once daily on days 1-28, low-dose oral methotrexate twice daily on days 1, 2, 8, 9, 15, 16, 22 and 23, and bevacizumab IV over 30-90 minutes on days 1 and 15. - Arm II: Patients receive cyclophosphamide and methotrexate as in arm I. In both arms, courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. Patients in arm II who have progressive disease have the option of discontinuing treatment or crossing over to arm I. PROJECTED ACCRUAL: A total of 36-66 patients (18-33 per treatment arm) will be accrued for this study within 7-12 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically or cytologically confirmed invasive breast cancer - Metastatic (stage IV) disease confirmed by histology or cytology, physical exam, or radiologic study - Measurable disease - At least one unidimensionally measurable lesion at least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan - Measurable lesions in a previously irradiated field must have progressed after radiotherapy - HER2-positive patients must have received prior trastuzumab (Herceptin^®) for advanced disease or in the adjuvant setting - No evidence of brain metastases by brain CT scan or MRI - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female Menopausal status - Not specified Performance status - ECOG 0-1 OR - Karnofsky 70-100% Life expectancy - More than 6 months Hematopoietic - Absolute neutrophil count 1,000/mm^3 - Platelet count 100,000/mm^3 - No bleeding diatheses (including hemoptysis) Hepatic - AST and ALT 4.0 times upper limit of normal (ULN) - Bilirubin 2 times ULN Renal - Creatinine 2.0 mg/dL - Urinary protein < 500 mg/24-hour-urine collection OR - Protein urinalysis < 1+ Cardiovascular - LVEF 50% by echocardiogram or nuclear medicine gated study - No poorly controlled hypertension - No prior blood clots - No symptomatic congestive heart failure - No unstable angina pectoris - No cardiac arrhythmia Other - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception - No history of grade 3 or 4 allergic reaction to compounds of similar chemical or biological composition to cyclophosphamide or methotrexate - No concurrent uncontrolled illness - No active or ongoing infection - No psychiatric illness or social situation that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy - See Disease Characteristics - No prior experimental angiogenesis inhibitors - No concurrent filgrastim (G-CSF) - Concurrent epoetin alfa growth factor support allowed Chemotherapy - Prior adjuvant chemotherapy for early-stage breast cancer allowed, including cyclophosphamide-based chemotherapy - No more than 1 prior chemotherapy regimen for metastatic breast cancer - No prior oral cyclophosphamide- or methotrexate-based therapy for metastatic disease Endocrine therapy - Prior hormonal therapy in the adjuvant or metastatic setting or for early-stage breast cancer allowed - No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists Radiotherapy - See Disease Characteristics - Prior radiotherapy in the metastatic or early-stage setting allowed - Concurrent radiotherapy allowed Surgery - More than 28 days since prior surgery except for venous access device or diagnostic study Other - Recovered from prior therapy - No concurrent anticoagulation or chronic aspirin therapy (> 325 mg/day) - Concurrent low-dose anticoagulation or thrombolytic agents for venous access patency allowed - No other concurrent investigational or experimental therapy - No other concurrent anticancer agents or therapies - Concurrent bisphosphonates allowed provided skeletal sites are not the primary sites used in assessing response - If skeletal sites are being followed for measurable response, bisphosphonates must be initiated at least 4 weeks before study entry
Total Enrollment:
Location and Contact Information:
Overall Study Official:
HaroldBurstein, Principal Investigator, Dana-Farber/Harvard Cancer Center
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute *Recruiting*
Boston, Massachusetts, 02115
United States
Recruiting Harold Burstein 617-632-3800
Additional Information:
Study ID Numbers: CDR0000361807; DFCI-03083
Study Start Date:
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00083031
Other Recurrent Breast Cancer Studies:
1. Vinorelbine and Docetaxel in Treating Women With Metastatic Breast Cancer
2. Liposomal Doxorubicin and Trastuzumab in Treating Women With Locally Advanced, Inflammatory, or Metastatic Breast Cancer
3. 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
4. Docetaxel Combined With Estramustine in Treating Patients With Metastatic Breast Cancer
5. Bevacizumab in Treating Patients With Metastatic Breast or Colorectal Cancer Who Received Bevacizumab on a Phase II or Phase III Clinical Trial
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Metronomic Low-Dose Cyclophosphamide and Methotrexate With or Without Bevacizumab in Treating Women With Metastatic Breast Cancer
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