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BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Clinical Trials Resources presented on Clinical Trials Search is not meant to be a substitute for proven health advice, calls or treatment with a real medical. We aren't mDs. Always consult your doctor on BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Clinical research trials and BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer healthcare trials take place in a lot of 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 assess the effectiveness of new does drugs. The function of the studies / projects is to figure out specific human medical questions. Clinical trials are a popular means for doctors, government agencies, and private sector corporations to find cures for all varieties of conditions, like BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer. BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer Clinical Trials and other clinical trials allow volunteers to access health treatment options before they are available to the masses. Many times the subjects receive professional assistance for free, and every now and again they are compensated for their time. Sometimes there is a cost for a BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer clinical trial. Human subjects often obtain the finest healthcare possible for their BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer condition. Hazards are a reality, nevertheless, and might include additional or frequent dr. calls, health hazards (potentially life-jeopardizing), and/or the treatment being uneffective. Trials are federally regulated with stern guidelines to protect clinical trials patients.
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Home > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer  BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
For Condition: Head and Neck Cancer
Status: Suspended
Sponsor(s): Eastern Cooperative Oncology Group , 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. PURPOSE: Randomizedphase II trial to study the effectiveness of BMS-247550 in treating patients who have metastatic or recurrent head and neck cancer.
Details: OBJECTIVES: - Compare the response rate in patients with metastatic or recurrent squamous cell carcinoma of the head and neck treated with 2 different dosing schedules of BMS-247550. - Compare the toxicity of these drug schedules in these patients. - Correlate survivin expression with therapeutic responsiveness to this drug in these patients. - Correlate changes in tumor vascular density and endothelial cell apoptosis with outcome in patients treated with this drug. OUTLINE: This is a randomized study. Patients are stratified according to prior taxane therapy (yes vs no) and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment arms. - Arm I: Patients receive BMS-247550 IV over 1 hour on days 1-5. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity. - Arm II: Patients receive BMS-247550 IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. In both arms, patients achieving complete response (CR) receive 2 additional courses past CR if a minimum of 6 courses have been administered. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 64-144 patients (16-36 per stratum) will be accrued for this study within 8-18 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed squamous cell carcinoma of the head and neck (SCCHN) that is incurable with surgery or radiotherapy - No nasopharyngeal primaries - Measurable disease - If the only site of measurable disease is in a previously irradiated area, then patient must have documented disease progression or biopsy-proven residual carcinoma - Persistent disease after radiotherapy must be biopsy proven at least 8 weeks after completion of radiotherapy - Must have distant metastases or locoregional recurrence or persistent disease within a prior radiation portal PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - ECOG 0-1 Life expectancy: - Not specified Hematopoietic: - Absolute neutrophil count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than 1.5 mg/dL - AST and ALT no greater than 2 times upper limit of normal (ULN) - Alkaline phosphatase no greater than 2 times ULN Renal: - Creatinine no greater than 1.2 mg/dL OR - Creatinine clearance at least 50 mL/min - Calcium normal - No prior malignancy-associated hypercalcemia Other: - No other prior or concurrent malignancy within the past 2 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix - No grade 2 or greater pre-existing peripheral neuropathy - No active infection - No greater than grade 1 or uncomplicated, non-recurrent grade 2 hypersensitivity reaction to castor oil, agents containing Cremophor EL, or paclitaxel - Not pregnant or nursing - Negative pregnancy test - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 4 weeks since prior biotherapy regimen - No more than 1 prior biotherapy regimen Chemotherapy: - At least 4 weeks since prior chemotherapy - No more than 2 prior chemotherapy regimens for recurrent and/or metastatic SCCHN - No prior investigational taxane - Prior docetaxel or paclitaxel allowed Endocrine therapy: - Not specified Radiotherapy: - See Disease Characteristics - At least 4 weeks since prior radiotherapy Surgery: - Recovered from prior surgery Other: - No concurrent treatment for a recent infection
Total Enrollment:
Location and Contact Information:
Overall Study Official:
BarbaraBurtness, Study Chair, Yale Cancer Center
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
Mayo Clinic Cancer Center
Rochester, Minnesota, 55905
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611-4494
United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur, Georgia, 30033
United States
CCOP - Marshfield Clinic Research Foundation
Marshfield, Wisconsin, 54449
United States
CCOP - Central Illinois
Decatur, Illinois, 62526
United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, 33612-9497
United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231
United States
University of Minnesota Cancer Center
Minneapolis, Minnesota, 55455
United States
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6307
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611
United States
CCOP - Iowa Oncology Research Association
Des Moines, Iowa, 50309-1016
United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx, New York, 10466
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
Albert Einstein Clinical Cancer Center
Bronx, New York, 10461
United States
CCOP - Illinois Oncology Research Association
Peoria, Illinois, 61602
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Pretoria Academic Hospital
Pretoria, , 0001
South Africa
CCOP - Christiana Care Health Services
Newark, Delaware, 19713
United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay, Wisconsin, 54307-3453
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-0001
United States
Additional Information:
Study ID Numbers: CDR0000069305; ECOG-E2301
Study Start Date:
Record last reviewed: March 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00033618
Other Head And Neck Cancer Studies:
1. A Phase I Study To Test The Safety Of DAVANAT With and Without 5-Fluorouracil In Patients With Solid Tumors
2. Photodynamic Therapy in Treating Patients With Skin Cancer or Solid Tumors Metastatic to the Skin
3. ONYX-015 With Cisplatin and Fluorouracil in Treating Patients With Advanced Head and Neck Cancer
4. Docetaxel in Treating Patients With Solid Tumors
5. Erlotinib Plus Docetaxel in Treating Patients With Locally Advanced, Metastatic, or Recurrent Head and Neck Cancer
Related Studies:
Other Head and Neck Cancer Clinical Trials
Other Florida Clinical Trials
Other Tampa Clinical Trials
BMS-247550 in Treating Patients With Metastatic or Recurrent Head and Neck Cancer
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