Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005847
Status:
COMPLETED
Last Update Posted:
2023-06-22
First Post:
2000-06-02
Brief Title:
Chemotherapy With or Without Biological Therapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
A Randomized Phase II Trial of Mitoxantrone Estramustine and Navelbine or 13-cis Retinoic Acid Interferon and Paclitaxel in Patients With Metatstatic Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2023-06
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 use different ways to stop tumor cells from dividing so they stop growing or die Combining more than one drug may kill more tumor cells Biological therapies use different ways to stimulate the immune system and stop cancer cells from growing It is not yet known which treatment regimen is more effective in treating metastatic prostate cancer
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy with that of chemotherapy plus biological therapy in treating patients who have progressive or metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Randomized phase II trial to compare the effectiveness of combination chemotherapy with that of chemotherapy plus biological therapy in treating patients who have progressive or metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Compare the effect of estramustine mitoxantrone and vinorelbine vs isotretinoin interferon alfa and paclitaxel on PSA response in patients with metastatic hormone-refractory prostate cancer
Determine the toxic effects of each regimen in this patient population
Determine the effect of each regimen on pain fatigue and quality of life in these patients
Determine the objective response rate among the subset of patients who have bidimensionally measurable disease to each regimen after treatment
Determine the effect of each regimen on peripheral blood mononuclear cell BCL-2 in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease measurable vs nonmeasurable and elevated PSA Patients are randomized to one of two treatment arms
Arm I Patients receive vinorelbine IV over 10 minutes on days 2 and 9 followed by mitoxantrone IV over 10 minutes on day 2 only Oral estramustine is administered every 12 hours on days 1-5 Courses repeat every 3 weeks in the absence of unacceptable toxicity disease progression or administration of the maximum cumulative dose of mitoxantrone
Arm II Patients receive oral isotretinoin and interferon alfa subcutaneously on days 1 and 2 and paclitaxel IV over 1 hour on day 2 weekly for 6 weeks Courses repeat every 8 weeks in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline on day 2 of courses 2 4 and 6 arm I on day 22 of course 1 and day 1 of courses 2 and 3 arm II and then at completion of treatment
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 70-114 patients 35-57 per arm will be accrued for this study within 14-23 months
Compare the effect of estramustine mitoxantrone and vinorelbine vs isotretinoin interferon alfa and paclitaxel on PSA response in patients with metastatic hormone-refractory prostate cancer
Determine the toxic effects of each regimen in this patient population
Determine the effect of each regimen on pain fatigue and quality of life in these patients
Determine the objective response rate among the subset of patients who have bidimensionally measurable disease to each regimen after treatment
Determine the effect of each regimen on peripheral blood mononuclear cell BCL-2 in these patients
OUTLINE This is a randomized multicenter study Patients are stratified according to disease measurable vs nonmeasurable and elevated PSA Patients are randomized to one of two treatment arms
Arm I Patients receive vinorelbine IV over 10 minutes on days 2 and 9 followed by mitoxantrone IV over 10 minutes on day 2 only Oral estramustine is administered every 12 hours on days 1-5 Courses repeat every 3 weeks in the absence of unacceptable toxicity disease progression or administration of the maximum cumulative dose of mitoxantrone
Arm II Patients receive oral isotretinoin and interferon alfa subcutaneously on days 1 and 2 and paclitaxel IV over 1 hour on day 2 weekly for 6 weeks Courses repeat every 8 weeks in the absence of unacceptable toxicity or disease progression
Quality of life is assessed at baseline on day 2 of courses 2 4 and 6 arm I on day 22 of course 1 and day 1 of courses 2 and 3 arm II and then at completion of treatment
Patients are followed every 3 months for 2 years every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 70-114 patients 35-57 per arm will be accrued for this study within 14-23 months
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 |
|---|---|---|---|
| E-3899 | None | None | None |