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BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer Clinical Trials Info presented on Clinical Trials Search isn't intended to be a substitute for qualified medical advice, visits or professional assistance by using a real mD. We are not docs. Always confer with your physician about BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer conditions. Clinical Trials Search.org is a website committed 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 occur in many 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 effectivity of new does drugs. The intent of the studies / undertakings is to resolve particular human health questions. Clinical trials are a popular way for physicians, government agencies, and private sector companies to detect remedies for all sorts of conditions, including 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 permit volunteers to obtain healthcare treatment alternatives before they are available to the masses. Most times the participants undergo professional assistance for without cost, and occasionally they are compensated for their time. Occasionally there is a cost for a BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer clinical trial. Test subjects typically receive the most expert 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 more or frequent mD visits, healthcare dangers (perhaps life-endangering), and/or the treatment being ineffectual. Trials are federally regulated with rigid 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 3b Breast Cancer Studies:
1. EGb761 in Maintaining Mental Clarity in Women Receiving Chemotherapy for Newly Diagnosed Breast Cancer
2. Combination Chemotherapy in Treating Patients With Stage III Breast Cancer
3. Adjuvant Chemotherapy and/or Hormone Therapy With or Without Zoledronate in Treating Women With Stage II or Stage III Breast Cancer
4. Tipifarnib and Fulvestrant as Second-Line Therapy in Treating Postmenopausal Women With Hormone Receptor-Positive Inoperable Locally Advanced or Metastatic Breast Cancer With Progressive Disease After Previous First-Line Endocrine Therapy
5. Combination Chemotherapy, Monoclonal Antibody Therapy, and Surgery in Treating Women With Stage II, Stage III, or Stage IV Breast Cancer
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BMS-247550 in Treating Patients With Locally Advanced or Metastatic Breast Cancer
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