Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004071
Status:
COMPLETED
Last Update Posted:
2012-09-11
First Post:
1999-12-10
Brief Title:
Mitoxantrone and Prednisone With or Without Leflunomide in Treating Patients With Stage IV Prostate Cancer
Sponsor:
Pfizer
Organization:
Pfizer
Study Overview
Official Title:
A Randomized Open-Label Phase IIIII Study of SU101 Plus MitoxantronePrednisone Compared to MitoxantronePrednisone Alone in Patients With Hormone-Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2012-09
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 It is not yet known if mitoxantrone and prednisone are more effective with or without leflunomide for treating prostate cancer
PURPOSE Randomized phase IIIII trial to compare the effectiveness of mitoxantrone and prednisone with or without leflunomide in treating patients who have stage IV prostate cancer that has not responded to hormone therapy
PURPOSE Randomized phase IIIII trial to compare the effectiveness of mitoxantrone and prednisone with or without leflunomide in treating patients who have stage IV prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Compare the percentage one year survival rate in hormone refractory prostate cancer patients treated with leflunomide SU101 mitoxantrone and prednisone versus mitoxantrone and prednisone alone II Compare the palliative pain response time to treatment failure time to progression median survival investigator global response assessment objective response time to palliative pain response duration of palliation and effect on PSA between these two regimens III Assess the safety and tolerability of mitoxantrone in combination with SU101 in these patients IV Assess the health related quality of life of these patients on these regimens
OUTLINE This is a randomized open label multicenter study Patients are stratified by performance status 70-80 vs 90-100 baseline present pain intensity score 20 vs greater than 20 and hemoglobin level less than 120 gdL vs at least 120 gdL Patients enter one of two treatment arms Arm I Patients are premedicated with an IV 5-HT3 reuptake inhibitor ie odansetron then receive mitoxantrone IV on day 1 Twice daily oral prednisone therapy begins on day 1 and continues throughout study treatment Treatment repeats every 21 days for 4 courses Arm II Patients are premedicated with an IV 5-HT3 reuptake inhibitor as in arm I Patients receive mitoxantrone and prednisone therapy as in arm I Additionally beginning on day 1 patients receive leflunomide SU101 IV over 4-5 hours weekly for 12 weeks The SU101 infusions shall precede mitoxantrone infusions Patients receive a maximum of one year therapy with SU101 mitoxantrone therapy may be administered up to a maximum dose of 140m2 Quality of life is assessed at baseline day 8 day 21 and then every 3 weeks thereafter until study completion Patients are followed at least every 2 months
PROJECTED ACCRUAL Up to 370 patients will be accrued for this study
OUTLINE This is a randomized open label multicenter study Patients are stratified by performance status 70-80 vs 90-100 baseline present pain intensity score 20 vs greater than 20 and hemoglobin level less than 120 gdL vs at least 120 gdL Patients enter one of two treatment arms Arm I Patients are premedicated with an IV 5-HT3 reuptake inhibitor ie odansetron then receive mitoxantrone IV on day 1 Twice daily oral prednisone therapy begins on day 1 and continues throughout study treatment Treatment repeats every 21 days for 4 courses Arm II Patients are premedicated with an IV 5-HT3 reuptake inhibitor as in arm I Patients receive mitoxantrone and prednisone therapy as in arm I Additionally beginning on day 1 patients receive leflunomide SU101 IV over 4-5 hours weekly for 12 weeks The SU101 infusions shall precede mitoxantrone infusions Patients receive a maximum of one year therapy with SU101 mitoxantrone therapy may be administered up to a maximum dose of 140m2 Quality of life is assessed at baseline day 8 day 21 and then every 3 weeks thereafter until study completion Patients are followed at least every 2 months
PROJECTED ACCRUAL Up to 370 patients will be accrued for this study
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 |
|---|---|---|---|
| SUGEN-990711 | None | None | None |
| CDR0000067275 | None | None | None |