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Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified medical advice, visits or professional assistance with a genuine dr.. We are not doctors. Always consult your mD about Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer Clinical research trials and Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer medical trials take place in many of places throughout 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 usually evaluate the effectiveness of new does drugs. The purpose of the studies / projects is to solve specific human healthcare questions. Clinical trials are a popular way for mDs, government agencies, and private sector companies to find cures for all varieties of conditions, like Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer. Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer Clinical Trials and other clinical trials allow for volunteers to have health treatment options before they are available to the masses. Many times the human subjects acquire professional assistance for free of charge, and sometimes they are compensated for their time. Occasionally there is a cost for a Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer clinical trial. Test subjects typically obtain the finest healthcare available for their Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer condition. Dangers are a reality, nevertheless, and might include additional or frequent doctor trips, medical dangers (possibly life-jeopardising), and/or the treatment being ineffectual. Trials are federally regulated with strict guidelines to protect clinical trials patients.
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Home > "L" Clinical Trials Conditions > Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer  Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
For Condition: stage 3 prostate cancer,stage 4 prostate cancer,adenocarcinoma of the prostate,recurrent prostate cancer
Status: No longer recruiting
Sponsor(s): National Cancer Institute (NCI) , Southwest Oncology Group,Eastern Cooperative Oncology Group,Cancer and Leukemia Group B
Synopsis: RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known which regimen of suramin is more effective for prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of low, intermediate, and high dose suramin in treating men with stage IV prostate cancer that is refractory to hormone therapy.
Details: OBJECTIVES: I. Compare the response in patients with advanced hormone-refractory adenocarcinoma of the prostate treated with low- vs intermediate- vs high-dose suramin. II. Compare the toxic effects of these regimens in these patients. III. Compare the overall and failure-free survival of patients treated with these regimens. IV. Compare the duration of complete and partial responses in patients treated with these regimens. V. Determine the population pharmacokinetics of these regimens and correlate these parameters with the toxicity of these regimens and response rate in these patients. VI. Compare the quality of life of patients treated with these regimens. VII. Determine the relationship of absolute and relative decrease in PSA and rate of PSA decrease with the likelihood and duration of response in patients treated with these regimens. VIII. Determine whether a change in fibroblast growth factor levels in patients treated with suramin can be associated with the pharmacokinetics of suramin or the likelihood of clinical response in these patients. PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease site (bone only vs soft tissue), CALGB/Zubrod performance status (0 or 1 vs 2), number of prior hormonal therapies (1 or 2 vs 3), and participating center. Patients are randomized to 1 of 3 treatment arms. Arm I: Patients receive low-dose suramin IV over 1 hour on days 1, 2, 8, 9, 29, 30, 36, 37, 57, 58, 64, and 65 in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive intermediate-dose suramin as in arm I. Arm III: Patients receive high-dose suramin as in arm I. Patients with new progression after partial or complete response may receive additional courses, at the discretion of the study chairperson, beginning at least 12 weeks after completion of the first course and continuing in the absence of disease progression or unacceptable toxicity. Quality of life is assessed. Patients are followed every 4 weeks until disease progression and then periodically for new primary cancer(s) and survival. PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.
Eligibility:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- - Histologically proven adenocarcinoma of the prostate with progressive metastatic or progressive regional nodal disease; PSA evidence of progression defined as at least 50% increase over baseline on at least 2 measurements at least 2 weeks apart - Measurable disease preferred but not required; Bone scan abnormalities acceptable provided PSA at least 10 ng/mL; No minimum PSA value required if measurable disease present - Progression after or during an adequate trial of hormonal therapy; No more than 3 prior hormonal interventions for progressive disease; One prior hormonal intervention is defined by any of the following: Concurrent testicular and adrenal androgen ablation (e.g., leuprolide, goserelin, orchiectomy, or diethylstilbestrol (DES) plus flutamide, bicalutamide, nilutamide, megestrol, or other antiandrogen); Initial LHRH agonist followed by orchiectomy provided no progression prior to orchiectomy; Prior intermittent androgen deprivation on protocol SWOG-9346; Corticosteroids for metastatic disease or in conjunction with aminoglutethimide or ketoconazole; Two prior hormonal interventions are defined by the following: Antiandrogen given for disease progression more than 3 months after initial hormonal therapy - Prior neoadjuvant or adjuvant deprivation for treatment of nonmetastatic disease not considered a prior hormonal intervention - Antiandrogen withdrawal not considered a separate hormonal intervention; At least 4 weeks since antiandrogen withdrawal or megestrol withdrawal; Failure to respond to (i.e., no decrease in PSA at 2 and 4 weeks) or progression after a transient response to antiandrogen withdrawal or megestrol withdrawal required - Primary testicular androgen suppression (e.g., LHRH agonist or DES) continues during study - No brain metastases or other CNS disease --Prior/Concurrent Therapy-- - Biologic therapy: No prior immunotherapy for metastatic disease - Chemotherapy: No prior chemotherapy (including estramustine) for metastatic disease - Endocrine therapy: See Disease Characteristics; No concurrent megestrol or other hormonal agents; No concurrent systemic or inhaled corticosteroids (intranasal and topical steroids allowed) - Radiotherapy: At least 4 weeks since prior radiotherapy (8 weeks for strontium therapy) - Surgery: See Disease Characteristics - Other: No prior experimental therapy for metastatic disease; No concurrent heparin, warfarin, or aspirin --Patient Characteristics-- - Age: 18 and over - Performance status: CALGB 0-2 OR Zubrod 0-2 - Life expectancy: At least 3 months - Hematopoietic: WBC at least 3,000/mm3; Absolute neutrophil count at least 1,200/mm3; Platelet count at least 100,000/mm3; Hemoglobin at least 9 g/dL; Fibrinogen at least 200 mg/dL; No prior hemorrhagic or thrombotic disorders - Hepatic: Bilirubin normal; AST/ALT no greater than 2.5 times normal; Prothrombin time, partial thromboplastin time, and thrombin time normal - Renal: Creatinine clearance at least 70 mL/min - Other: No primary muscle disease; No active, uncontrolled bacterial, viral, or fungal infection; No grade 1 or worse peripheral neuropathy ;No underlying medical condition that would preclude study; No other serious medical illness that limits survival to less than 3 months; No psychiatric condition that would preclude informed consent; No other malignancy within the past 5 years except inactive nonmelanomatous skin cancer or adequately treated stage I or II cancer in remission
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardSchilsky, Study Chair, Cancer and Leukemia Group B
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, 37232-6838
United States
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, 07018-1095
United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
United States
CCOP - Ann Arbor Regional
Ann Arbor, Michigan, 48106
United States
Albert Einstein Comprehensive Cancer Center
Bronx, New York, 10461
United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis, Minnesota, 55417
United States
Ireland Cancer Center
Cleveland, Ohio, 44106-5065
United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago, Illinois, 60611
United States
Veterans Affairs Medical Center - Madison
Madison, Wisconsin, 53705
United States
CCOP - Kalamazoo
Kalamazoo, Michigan, 49007-3731
United States
CCOP - Marshfield Medical Research and Education Foundation
Marshfield, Wisconsin, 54449
United States
Pretoria Academic Hospitals
Pretoria, , 0001
South Africa
CCOP - Metro-Minnesota
St. Louis Park, Minnesota, 55416
United States
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, 53792-6164
United States
CCOP - Duluth
Duluth, Minnesota, 55805
United States
Robert H. Lurie Comprehensive Cancer Center, Northwestern University
Chicago, Illinois, 60611-3013
United States
CCOP - Toledo Community Hospital Oncology Program
Toledo, Ohio, 43623-3456
United States
CCOP - MainLine Health
Wynnewood, Pennsylvania, 19096
United States
CCOP - Carle Cancer Center
Urbana, Illinois, 61801
United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville, Tennessee, 37212
United States
CCOP - Northern New Jersey
Hackensack, New Jersey, 07601
United States
CCOP - Geisinger Clinic and Medical Center
Danville, Pennsylvania, 17822-2001
United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls, South Dakota, 57104
United States
Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee, Wisconsin, 53295
United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids, Iowa, 52403-1206
United States
CCOP - Merit Care Hospital
Fargo, North Dakota, 58122
United States
Additional Information:
Study ID Numbers: CDR0000064583; CLB-9480,INT-0159
Study Start Date: January 1996
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00002723
Other Stage 3 Prostate Cancer Studies:
1. Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
2. Combination Chemotherapy Plus Warfarin in Treating Patients With Prostate Cancer
3. MEN-10755 in Treating Patients With Progressive Prostate Cancer That Has Not Responded to Hormone Therapy
4. Epoetin alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
5. Morphine Plus Marijuana in Treating Pain Caused by Bone Metastases in Patients With Breast or Prostate Cancer
Related Studies:
Other stage 3 prostate cancer Clinical Trials
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Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
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