Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004001
Status:
COMPLETED
Last Update Posted:
2014-02-25
First Post:
1999-11-01
Brief Title:
S9916 Combination Therapy in Treating Patients With Advanced Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Docetaxel and Estramustine Versus Mitoxantrone and Prednisone for Advanced Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2014-02
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:
RATIONALE Drugs used in chemotherapy and hormone therapy use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug and giving drugs in different ways may kill more tumor cells It is not yet known whether estramustine plus docetaxel is more effective than mitoxantrone plus prednisone for prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy
PURPOSE Randomized phase III trial to compare the effectiveness of estramustine plus docetaxel with that of mitoxantrone plus prednisone in treating patients who have stage IV prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Compare the overall survival and progression-free survival in patients with hormone-refractory metastatic adenocarcinoma of the prostate treated with docetaxel and estramustine vs mitoxantrone and prednisone
Compare the qualitative and quantitative toxic effects of these regimens in this patient population
Compare the quality of life including palliation of metastatic bone pain and global quality of life of patients treated with these regimens
Record prostate-specific antigen values for future correlations with response and survival in patients treated with these regimens
Compare the responses in patients with bidimensionally measurable disease treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status measurable or evaluable disease progression vs rising PSA only NCI Common Toxicity Criteria version 2X pain scale grade 2 or greater vs less than 2 and SWOG performance status 0-1 vs 2-3 Patients are randomized to one of two treatment arms
Arm I Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2
Arm II Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21
Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline after courses 4 and 8 and then at 1 year after randomization
Patients are followed every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 620 patients 310 per arm will be accrued for this study within 35 years
Compare the overall survival and progression-free survival in patients with hormone-refractory metastatic adenocarcinoma of the prostate treated with docetaxel and estramustine vs mitoxantrone and prednisone
Compare the qualitative and quantitative toxic effects of these regimens in this patient population
Compare the quality of life including palliation of metastatic bone pain and global quality of life of patients treated with these regimens
Record prostate-specific antigen values for future correlations with response and survival in patients treated with these regimens
Compare the responses in patients with bidimensionally measurable disease treated with these regimens
OUTLINE This is a randomized multicenter study Patients are stratified according to disease status measurable or evaluable disease progression vs rising PSA only NCI Common Toxicity Criteria version 2X pain scale grade 2 or greater vs less than 2 and SWOG performance status 0-1 vs 2-3 Patients are randomized to one of two treatment arms
Arm I Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2
Arm II Patients receive mitoxantrone IV over 30 minutes on day 1 and oral prednisone twice daily on days 1-21
Treatment in both arms repeats every 3 weeks for a maximum of 12 courses in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline after courses 4 and 8 and then at 1 year after randomization
Patients are followed every 6 months for 2 years and then annually for 1 year
PROJECTED ACCRUAL A total of 620 patients 310 per arm will be accrued for this study within 35 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 |
|---|---|---|---|
| S9916 | OTHER | None | None |
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |