Ignite Creation Date:
2024-05-05 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003682
Status:
TERMINATED
Last Update Posted:
2016-06-23
First Post:
1999-11-01
Brief Title:
Methylprednisolone With or Without Doxorubicin in Treating Patients With Metastatic Prostate Cancer
Sponsor:
UNICANCER
Organization:
UNICANCER
Study Overview
Official Title:
Treatment of Metastatic Prostate Cancer That is Hormone-Independent Evaluation of the Role of Chemotherapy on the Quality of Life of Patients Phase II Study
Status:
TERMINATED
Status Verified Date:
2016-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
lack of inclusions
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 make cancer cells stop dividing so they stop growing or die Combining chemotherapy with corticosteroids may be an effective treatment for prostate cancer
PURPOSE Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Randomized phase III trial to compare the effectiveness of methylprednisolone with or without doxorubicin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the effect of weekly doxorubicin on the quality of life of patients with metastatic hormone-refractory symptomatic prostate cancer II Determine the contribution of this treatment on control of pain in these patients III Determine the toxicity of this regimen in these patients IV Determine the objective response and biological observations in these patients after this treatment V Determine the effect of this regimen on survival of these patients
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive methylprednisolone IV weekly for 3 months Arm II Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months Quality of life is assessed before treatment every 4 weeks during treatment and then every 3 months Patients are followed every 3 months
PROJECTED ACCRUAL A total of 160 patients will be accrued for this study within 3 years
OUTLINE This is a randomized multicenter study Patients are randomized to one of two treatment arms Arm I Patients receive methylprednisolone IV weekly for 3 months Arm II Patients receive methylprednisolone IV and doxorubicin IV weekly for 3 months Quality of life is assessed before treatment every 4 weeks during treatment and then every 3 months Patients are followed every 3 months
PROJECTED ACCRUAL A total of 160 patients will be accrued for this study within 3 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 |
|---|---|---|---|
| FRE-FNCLCC-GETUG-02 | None | None | None |
| EU-98058 | None | None | None |