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BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer Clinical Trials Info presented on Clinical Trials Search is not intended to be a substitute for certified medical advice, visits or professional assistance using a real physician. We are not physicians. Always consult your dr. about BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a site dedicated to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer Clinical research trials and BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer health trials happen in many of localities throughout the U.S.. 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 drugs. The function of the studies / projects is to resolve particular human medical questions. Clinical trials are a popular manner for mDs, government agencies, and private sector corporations to discover remedies for all varieties of circumstances, like BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer. BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer Clinical Trials and other clinical trials allow volunteers to obtain healthcare treatment options before they are available to the masses. Some times the participants undergo professional assistance for free of charge, and occasionally they are paid for their time. Sometimes there is a cost for a BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer clinical trial. Human subjects often get the best healthcare available for their BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer condition. Dangers are a reality, however, and may include additional or frequent mD visits, healthcare dangers (potentially life-jeopardising), and/or the treatment being ineffectual. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer  BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
For Condition: Male Breast Cancer,recurrent breast cancer,stage 4 breast cancer,stage 3C breast cancer,stage 3B breast cancer
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. PURPOSE: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have locally advanced or metastatic breast cancer.
Details: OBJECTIVES: - Determine any antitumor activity of BMS-247550, in terms of objective response rate, in patients with incurable, locally advanced or metastatic breast cancer. - Determine the toxicity of this drug in these patients. OUTLINE: This is a multicenter study. Patients are stratified according to prior taxane therapy (yes vs no). Patients (with or without prior taxane exposure) receive BMS-247550 IV over 1 hour on days 1-5. An additional cohort of 37 patients who have received prior taxane therapy are then accrued to receive BMS-247550 IV over 1 hour on days 1-3 at a higher starting dose. For all patients, courses repeat every 3 weeks in the absence of disease progression or unacceptable toxicity. Patients who receive more than 6 courses with satisfactory response may be treated every 4-5 weeks. PROJECTED ACCRUAL: A total of 105 patients (at least 74 with and 21 without prior taxane exposure) will be accrued for this study within 26 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the breast - Incurable, locally advanced or metastatic disease - Primarily stage IV disease, but some inoperable stage III disease may be eligible (e.g., a patient with T4 and/or N2-3 disease who cannot receive doxorubicin or who has already received other therapy) - Measurable disease - No evidence of CNS metastases by brain MRI or contrast head CT scan - CNS metastases controlled by radiotherapy or surgical resection at least 6 months prior to study enrollment are allowed - Hormone receptor status: - Not specified PATIENT CHARACTERISTICS: Age - 18 and over Sex - Female or male Menopausal status - Not specified Performance status - ECOG 0-2 Life expectancy - At least 3 months Hematopoietic - Granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic - Bilirubin no greater than 1.5 times upper limit of normal (ULN) (3 times ULN if there is clinical evidence of Gilbert's disease) - AST and ALT no greater than 2.5 times ULN Renal - Creatinine normal OR - Creatinine clearance greater than 40 mL/min Other - No poor medical risk due to other nonmalignant systemic disease - No active uncontrolled infection - No sensory, motor, or cranial neuropathy or neuropathic pain grade 2 or greater - No other concurrent serious medical illness - No prior severe hypersensitivity reactions to agents containing Cremophor EL - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception during and for 2 months after study participation PRIOR CONCURRENT THERAPY: Biologic therapy - No concurrent immunotherapy Chemotherapy - More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) - No other concurrent chemotherapy for breast cancer Endocrine therapy - More than 2 weeks since prior hormonal therapy - No concurrent hormonal therapy Radiotherapy - See Disease Characteristics - No prior craniospinal radiation - No prior total body irradiation - More than 4 weeks since prior radiotherapy Surgery - See Disease Characteristics Other - No other concurrent investigational drugs - No concurrent cytochrome p450 3A4 inhibitors, including amiodarone, clarithromycin, erythromycin, fluconazole, itraconazole, ketoconazole, indinavir, nelfinavir, ritonavir, or saquinavir - Concurrent bisphosphonates for bone metastases allowed
Total Enrollment:
Location and Contact Information:
Overall Study Official:
JenniferLow, Study Chair, National Cancer Institute (NCI)
Hillman Cancer Center at University of Pittsburgh Cancer Institute *Recruiting*
Pittsburgh, Pennsylvania, 15236
United States
Recruiting Adam Brufsky 412-641-2107
Center for Cancer Research *Recruiting*
Bethesda, Maryland, 20892
United States
Recruiting Arlene Berman 301-435-5609
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support *Recruiting*
Bethesda, Maryland, 20892-1182
United States
Recruiting Patient Recruitment 888-NCI-1937
Additional Information:
Study ID Numbers: CDR0000256355; NCI-02-C-0229,NCI-5791
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045097
Other Stage 4 Breast Cancer Studies:
1. Antineoplaston Therapy in Treating Women With Advanced Breast Cancer
2. Trastuzumab With or Without Tamoxifen in Treating Women With Progressive Stage IV Breast Cancer
3. Combination Chemotherapy, Surgery, and Radiation Therapy With or Without Dexrazoxane and Trastuzumab in Treating Women With Stage III or Stage IV Breast Cancer
4. Paclitaxel With or Without Gemcitabine in Treating Women With Advanced Breast Cancer
5. Comparison of Two Regimens of Liposomal Doxorubicin in Treating Women with Metastatic Breast Cancer
Related Studies:
Other stage 4 breast cancer Clinical Trials
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BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
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