Low, Intermediate, or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
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. 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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A PHASE III STUDY OF THREE DIFFERENT DOSES OF SURAMIN (NSC #34936) ADMINISTERED WITH A FIXED DOSING SCHEDULE IN PATIENTS WITH ADVANCED PROSTATE CANCER|
- Response [ Time Frame: Week 12 and then monthly ] [ Designated as safety issue: No ]PSA levels
- Response [ Time Frame: Week 12 and every 12 weeks thereafter ] [ Designated as safety issue: No ]Radiographic evaluation
- Toxicity [ Time Frame: pre-study, day 1, then every 2 weeks during treatment and every 8 weeks during follow up ] [ Designated as safety issue: Yes ]
- Survival [ Time Frame: post treatment until patient expires ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: pre-study, 2 weeks post treatment, and every 12 weeks in follow up ] [ Designated as safety issue: No ]
|Study Start Date:||January 1996|
|Study Completion Date:||March 2008|
|Primary Completion Date:||August 2002 (Final data collection date for primary outcome measure)|
Experimental: Low dose suramin
Low dose suramin
3.192g/square meter total dose given decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65.
Other Name: NSC #34936
Experimental: Intermediate dose suramin
Intermediate dose suramin
5.320 g/square meter total dose given in decreasing concentrations in 250 cc normal saline via IV over 1 hour on days 1,2,8,9,29,30,36,37,57,58,64,and 65
Other Name: NSC #34936
Experimental: High dose suramin
High dose suramin
7.661 g/square meter toal dose given in decreasing concentrations in 250 cc normal saline IV over 1 hour on days 1,2,8,9,29,30,36,37,5,58,64,and 65.
Other Name: NSC #34936
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.
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.
Show 27 Study Locations
|Study Chair:||Eric J. Small, MD||University of California, San Francisco|
|Study Chair:||Daniel P. Petrylak, MD||Herbert Irving Comprehensive Cancer Center|
|Study Chair:||George Wilding, MD||University of Wisconsin, Madison|