Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134056
Status:
COMPLETED
Last Update Posted:
2021-10-27
First Post:
2005-08-22
Brief Title:
S0421 Docetaxel and Prednisone With or Without Atrasentan in Treating Patients With Stage IV Prostate Cancer and Bone Metastases That Did Not Respond to Previous Hormone Therapy
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Phase III Study of Docetaxel and Atrasentan Versus Docetaxel and Placebo for Patients With Advanced Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2021-10
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 such as docetaxel prednisone and atrasentan work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving more than one drug combination chemotherapy may kill more tumor cells It is not yet known whether docetaxel prednisone and atrasentan are more effective than docetaxel and prednisone in treating prostate cancer
PURPOSE This randomized phase III trial is studying docetaxel prednisone and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy
PURPOSE This randomized phase III trial is studying docetaxel prednisone and atrasentan to see how well they work compared to docetaxel and prednisone in treating patients with stage IV prostate cancer and bone metastases that did not respond to previous hormone therapy
Detailed Description:
OBJECTIVES
Primary
Compare the survival and progression-free survival of patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo
Secondary
Compare pain progression of patients treated with these regimens
Compare the qualitative and quantitative toxicity of these regimens in these patients
Compare the quality of life in terms of palliation of metastatic bone pain and improvement in functional status of patients treated with these regimens
Compare prostate-specific antigen PSA response rates in patients treated with these regimens
Compare objective response in patients with measurable disease treated with these regimens
Determine whether a 30 reduction in PSA and the slope of PSA from baseline to 3 months is a surrogate marker for survival in patients treated with these regimens
Correlate PSA progression with clinical progression and death in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease progression measurable or non-measurable disease progression vs prostate-specific antigen progression only use of bisphosphonates at study entry yes vs no worst pain measured by the Brief Pain Inventory pain scale grade 4 vs grade 4 and extraskeletal metastases yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Patients also receive oral atrasentan and oral prednisone once daily on days 1-21 Treatment repeats every 21 days for up to 12 courses Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel and prednisone as in arm I Patients also receive oral placebo once daily on days 1-21 Treatment repeat every 21 days for up to 12 courses Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks in the absence of disease progression or unacceptable toxicity
NOTE Patients with PSA progression alone will be allowed to continue treatment
Quality of life is assessed at baseline before courses 4 7 and 10 and then after completion of study treatment
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 3 years from study entry
PROJECTED ACCRUAL A total of 930 patients will be accrued for this study within 4 years
Primary
Compare the survival and progression-free survival of patients with hormone-refractory stage IV prostate cancer and bone metastases treated with docetaxel and prednisone combined with either atrasentan vs placebo
Secondary
Compare pain progression of patients treated with these regimens
Compare the qualitative and quantitative toxicity of these regimens in these patients
Compare the quality of life in terms of palliation of metastatic bone pain and improvement in functional status of patients treated with these regimens
Compare prostate-specific antigen PSA response rates in patients treated with these regimens
Compare objective response in patients with measurable disease treated with these regimens
Determine whether a 30 reduction in PSA and the slope of PSA from baseline to 3 months is a surrogate marker for survival in patients treated with these regimens
Correlate PSA progression with clinical progression and death in patients treated with these regimens
OUTLINE This is a randomized double-blind placebo-controlled multicenter study Patients are stratified according to disease progression measurable or non-measurable disease progression vs prostate-specific antigen progression only use of bisphosphonates at study entry yes vs no worst pain measured by the Brief Pain Inventory pain scale grade 4 vs grade 4 and extraskeletal metastases yes vs no Patients are randomized to 1 of 2 treatment arms
Arm I Patients receive docetaxel IV over 1 hour on day 1 Patients also receive oral atrasentan and oral prednisone once daily on days 1-21 Treatment repeats every 21 days for up to 12 courses Patients with stable or responding disease after course 12 may register for continued oral atrasentan treatment for up to 52 weeks in the absence of disease progression or unacceptable toxicity
Arm II Patients receive docetaxel and prednisone as in arm I Patients also receive oral placebo once daily on days 1-21 Treatment repeat every 21 days for up to 12 courses Patients with stable or responding disease after course 12 may register for continued oral placebo treatment for up to 52 weeks in the absence of disease progression or unacceptable toxicity
NOTE Patients with PSA progression alone will be allowed to continue treatment
Quality of life is assessed at baseline before courses 4 7 and 10 and then after completion of study treatment
After completion of study treatment patients are followed every 3 months for 1 year and then every 6 months for up to 3 years from study entry
PROJECTED ACCRUAL A total of 930 patients will be accrued for this study within 4 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0421 | OTHER | None | None |