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BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy 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 BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy conditions. Clinical Trials Search.org is a website dedicated to listing clinical research studies in human subjects. BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy Clinical research trials and BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy 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 BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy. BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy 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 BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy clinical trial. Participants oftentimes recieve the finest healthcare available for their BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy 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 > "B" Clinical Trials Conditions > BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy  BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
For Condition: stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): Southwest 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: Phase II trial to study the effectiveness of BMS-247550 in treating patients who have prostate cancer that has not responded to hormone therapy.
Details: OBJECTIVES: - Determine the prostate-specific antigen response to BMS-247550 in patients with hormone-refractory prostate cancer. - Determine the overall survival and progression-free survival rate in patients treated with this drug. - Determine the objective response rate (confirmed and unconfirmed complete and partial responses) in those patients with measurable disease treated with this drug. - Evaluate the qualitative and quantitative toxic effects of this regimen in these patients. OUTLINE: This is a multicenter study. Patients receive BMS-247550 IV over 3 hours on day 1. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity. Patients achieving a complete response (CR) receive 2 additional courses beyond CR. Patients are followed every 3 months for 1 year and then every 6 months for 2 years. PROJECTED ACCRUAL: A total of 25-45 patients will be accrued for this study within 5-9 months.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed adenocarcinoma of the prostate - Stage D1 or D2 disease (T4, N0, M0; any T, N1-3, M0; or any T, any N, M1) - Unresponsive or refractory to prior hormonal therapy by at least 1 of the following: - Progression of unidimensionally measurable lesion outside of a prior radiation port - Progression of non-measurable disease (e.g., bone scan) - Rising prostate-specific antigen (PSA) on at least 2 consecutive measurements taken at least 7 days apart - PSA at least 5 ng/mL - No brain metastases PATIENT CHARACTERISTICS: Age: - Not specified Performance status: - Zubrod 0-2 Life expectancy: - Not specified Hematopoietic: - Absolute granulocyte count at least 1,500/mm^3 - Platelet count at least 100,000/mm^3 Hepatic: - Bilirubin no greater than upper limit of normal (ULN) - SGOT or SGPT no greater than 2.5 times ULN Renal: - Creatinine no greater than 2.0 mg/dL OR - Creatinine clearance at least 40 mL/min Other: - No other malignancy within the past 5 years except adequately treated squamous cell or basal cell skin cancer, any carcinoma in situ, or stage I or II cancer in complete remission - No other concurrent significant active illness that would preclude study participation - Recovered from major infections - Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: - At least 28 days since prior biologic therapy and recovered - No more than 1 prior biologic (non-cytotoxic) therapy - No concurrent biological response modifiers Chemotherapy: - No prior chemotherapy for this disease - No other concurrent chemotherapy Endocrine therapy: - See Disease Characteristics - At least 28 days since prior flutamide or ketoconazole - At least 42 days since prior bicalutamide or nilutamide - No concurrent hormonal therapy, except luteinizing hormone-releasing hormone therapy - No concurrent corticosteroids Radiotherapy: - See Disease Characteristics - Prior radiotherapy to less than 30% of bone marrow allowed - No prior strontium chloride Sr 89 or samarium Sm 153 lexidronam pentasodium - At least 28 days since prior radiotherapy and recovered - No concurrent radiotherapy Surgery: - Recovered from prior surgery - Prior orchiectomy allowed Other: - No concurrent unconventional therapy (e.g., St. John's Wort, PC-SPES, or other herbal remedy for prostate cancer) - Not planning to begin bisphosphonate therapy (patients already receiving bisphosphonates are eligible provided they have progressive disease)
Total Enrollment:
Location and Contact Information:
Overall Study Official:
PrimoLara, , University of California Davis Cancer Center
Danville Radiation Therapy Center
Memphis, Tennessee, 38104
United States
CCOP - Upstate Carolina
Spartanburg, South Carolina, 29303
United States
Harrington Cancer Center
Amarillo, Texas, 79106
United States
Veterans Affairs Medical Center - Portland
Portland, Oregon, 97207
United States
University of California Davis Cancer Center
Sacramento, California, 95817
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229-3900
United States
James P. Wilmot Cancer Center at University of Rochester Medical Center
Rochester, New York, 14642
United States
Brooke Army Medical Center
Fort Sam Houston, Texas, 78234-6200
United States
Veterans Affairs Medical Center - Wichita
Wichita, Kansas, 67218
United States
Louisiana State University Health Sciences Center - Shreveport
Shreveport, Louisiana, 71130-3932
United States
University of Kansas Medical Center
Kansas City, Kansas, 66160-7390
United States
Veterans Affairs Medical Center - Amarillo
Amarillo, Texas, 79106
United States
CCOP - Scott and White Hospital
Temple, Texas, 76508
United States
CCOP - Wichita
Wichita, Kansas, 67214-3882
United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles, California, 90033-0804
United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle, Washington, 98104
United States
Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital)
Hines, Illinois, 60141
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109-0330
United States
MBCCOP - LSU Health Sciences Center
New Orleans, Louisiana, 70112
United States
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, 48201-1932
United States
Veterans Affairs Medical Center - Seattle
Seattle, Washington, 98108
United States
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, 48201-1379
United States
Oregon Cancer Institute
Portland, Oregon, 97201-3098
United States
Herbert Irving Comprehensive Cancer Center at Columbia University
New York City, New York, 10032
United States
CCOP - Grand Rapids
Grand Rapids, Michigan, 49503
United States
CCOP - Atlanta Regional
Atlanta, Georgia, 30342-1701
United States
Veterans Affairs Medical Center - San Antonio (Murphy)
San Antonio, Texas, 78229
United States
Hollings Cancer Center at Medical University of South Carolina
Charleston, South Carolina, 29425
United States
Additional Information:
Study ID Numbers: CDR0000068629; SWOG-S0111
Study Start Date:
Record last reviewed: December 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00016393
Other Stage 4 Prostate Cancer Studies:
1. Calcitriol and Carboplatin in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Hormone Therapy
2. SU5416 Compared to Dexamethasone in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
3. Arsenic Trioxide in Treating Patients With Stage IV Prostate Cancer That Has Not Responded to Previous Hormone Therapy
4. R115777 in Treating Patients With Progressive, Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
5. PET Scan in Treating Patients With Metastatic Prostate Cancer
Related Studies:
Other stage 4 prostate cancer Clinical Trials
Other Kansas Clinical Trials
Other Wichita Clinical Trials
BMS-247550 in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
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