A Phase 3 interventional study of suramin and suramin in Prostate Cancer, sponsored by National Cancer Institute (NCI). Completed at 27 sites in 2 countries. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2013-02-28.
Sponsored by National Cancer Institute (NCI) · Phase 3, Interventional, and Treatment
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.
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,399 are open to participants now.
This study's enrollment of 390 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →National Cancer Institute (NCI) is the lead sponsor of 3,506 studies on the registry; 334 are open to participants now.
Of its 402 completed or terminated interventional studies of FDA-regulated products, 365 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically proven adenocarcinoma of the prostate with progressive metastatic or progressive regional nodal disease
Measurable disease preferred but not required
No more than 3 prior hormonal interventions for progressive disease
One prior hormonal intervention is defined by any of the following:
Two prior hormonal interventions are defined by the following:
Antiandrogen withdrawal not considered a separate hormonal intervention
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Other:
Low dose suramin
Drug: suramin
Intermediate dose suramin
Drug: suramin
High dose suramin
Drug: 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.
Also known as: NSC #34936
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
Also known as: NSC #34936
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.
Also known as: NSC #34936
Response
PSA levels
Time frame: Week 12 and then monthly
Response
Radiographic evaluation
Time frame: Week 12 and every 12 weeks thereafter
Toxicity
Time frame: pre-study, day 1, then every 2 weeks during treatment and every 8 weeks during follow up
Survival
Time frame: post treatment until patient expires
Quality of Life
Time frame: pre-study, 2 weeks post treatment, and every 12 weeks in follow up
This study is completed, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.
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National Cancer Institute (NCI)