Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002881
Status:
COMPLETED
Last Update Posted:
2010-11-09
First Post:
1999-11-01
Brief Title:
Flutamide Suramin and Hydrocortisone in Treating Patients With Prostate Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III TRIAL OF ORCHIECTOMYLHRH ANALOG FLUTAMIDE SURAMIN HYDROCORTISONE VS ORCHIECTOMYLHRH ANALOG FLUTAMIDE IN PATIENTS WITH METASTATIC PROSTATE CANCER
Status:
COMPLETED
Status Verified Date:
2007-05
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:
RATIONALE Hormone therapy may be an effective treatment for prostate cancer
PURPOSE Randomized phase III trial to evaluate the effectiveness of treatment with flutamide and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate cancer
PURPOSE Randomized phase III trial to evaluate the effectiveness of treatment with flutamide and suramin with or without hydrocortisone in men who have metastatic or recurrent prostate cancer
Detailed Description:
OBJECTIVES I Compare time to progression and survival in patients with metastatic or recurrent adenocarcinoma of the prostate treated with orchiectomy or LHRH analogue ie leuprolide or goserelin plus flutamide with vs without suramin and hydrocortisone II Compare these two treatments with respect to qualitative and quantitative toxic effects III Evaluate normalization of prostatic-specific antigen PSA duration of PSA response and the use of PSA as a surrogate marker of tumor response in these patients IV Compare these two treatments with respect to quality of life and pain status
OUTLINE This is a randomized study Patients are stratified by their choice of androgen suppression technique and by participating institution Within 3 days after randomization all patients receive daily flutamide On day 4 patients undergo orchiectomy or begin monthly LHRH analogue therapy with leuprolide or goserelin Patients randomized to receive suramin begin a 12-week course 8-25 days after orchiectomyLHRH therapy Hydrocortisone replacement therapy begins concomitantly with suramin and continues for at least 3 months after the completion of suramin treatment or until disease progression intervenes Patients are followed every 3 months
PROJECTED ACCRUAL A total of 800-1000 patients will be entered within 325 to 425 years
OUTLINE This is a randomized study Patients are stratified by their choice of androgen suppression technique and by participating institution Within 3 days after randomization all patients receive daily flutamide On day 4 patients undergo orchiectomy or begin monthly LHRH analogue therapy with leuprolide or goserelin Patients randomized to receive suramin begin a 12-week course 8-25 days after orchiectomyLHRH therapy Hydrocortisone replacement therapy begins concomitantly with suramin and continues for at least 3 months after the completion of suramin treatment or until disease progression intervenes Patients are followed every 3 months
PROJECTED ACCRUAL A total of 800-1000 patients will be entered within 325 to 425 years
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 |
|---|---|---|---|
| SWOG-E8892 | None | None | None |
| E-8892 | None | None | None |
| CLB-E8892 | None | None | None |