Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002723
Status:
COMPLETED
Last Update Posted:
2013-02-28
First Post:
1999-11-01
Brief Title:
Low Intermediate or High Dose Suramin in Treating Patients With Hormone-Refractory Prostate Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 CALGBZubrod 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 cancers and survival
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 CALGBZubrod 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 cancers and survival
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U10CA031946 | NIH | None | None |
| CALGB-9480 | None | None | None |
| E-C9480 | None | None | None |
| SWOG-9452 | None | None | None |
| INT-0159 | None | None | None |
| CDR0000064583 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchU10CA031946 |