Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003183
Status:
UNKNOWN
Last Update Posted:
2013-12-04
First Post:
1999-11-01
Brief Title:
Mitoxantrone and G-CSF in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Hope Cancer Institute Inc
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase III Trial Using Weekly Mitoxantrone Chemotherapy and G-CSF for the Treatment of Metastatic Hormone Refractory Prostate Cancer
Status:
UNKNOWN
Status Verified Date:
2001-04
Last Known Status:
ACTIVE_NOT_RECRUITING
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 chemotherapy with G-CSF may make tumor cells more sensitive to the chemotherapy drug and may kill more tumor cells
PURPOSE Phase III trial to study the effectiveness of mitoxantrone plus G-CSF in treating patients with metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase III trial to study the effectiveness of mitoxantrone plus G-CSF in treating patients with metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Study the effectiveness of mitoxantrone in patients with metastatic hormone refractory prostate cancer II Assess the side effects of mitoxantrone in this patient population III Determine whether filgrastim granulocyte colony-stimulating factor G-CSF treatment can overcome chronic bone marrow suppression and facilitate a dose intensive mitoxantrone chemotherapy regimen in this patient population
OUTLINE This is a dose escalation study Patients receive a 30 minute intravenous infusion of mitoxantrone once a week on day 1 On days 2-6 of each week patients receive subcutaneous filgrastim granulocyte colony-stimulating factor G-CSF Treatment continues for patients who respond to therapy and exhibit no disease progression Dose escalation proceeds until the maximum tolerated dose MTD of mitoxantrone with G-CSF support is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity After the MTD is determined an additional 20-40 patients are enrolled at this dose level to examine their response to this therapy
PROJECTED ACCRUAL Approximately 12-24 patients will be accrued for the phase I portion of this protocol An additional 20-40 patients may be accrued for the phase II portion of this study
OUTLINE This is a dose escalation study Patients receive a 30 minute intravenous infusion of mitoxantrone once a week on day 1 On days 2-6 of each week patients receive subcutaneous filgrastim granulocyte colony-stimulating factor G-CSF Treatment continues for patients who respond to therapy and exhibit no disease progression Dose escalation proceeds until the maximum tolerated dose MTD of mitoxantrone with G-CSF support is determined The MTD is defined as the dose preceding that at which 2 or more patients experience dose limiting toxicity After the MTD is determined an additional 20-40 patients are enrolled at this dose level to examine their response to this therapy
PROJECTED ACCRUAL Approximately 12-24 patients will be accrued for the phase I portion of this protocol An additional 20-40 patients may be accrued for the phase II portion of 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 |
|---|---|---|---|
| NCI-V98-1377 | None | None | None |
| HCRN-006 | None | None | None |