Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006114
Status:
UNKNOWN
Last Update Posted:
2011-03-01
First Post:
2000-08-03
Brief Title:
Combination Chemotherapy in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
GERCOR - Multidisciplinary Oncology Cooperative Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
First Line Treatment of Metastatic Hormone Refractory Prostate Cancer With a Combination of Novantrone-Navelbine
Status:
UNKNOWN
Status Verified Date:
2000-09
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 more than one drug may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of combination chemotherapy in treating patients who have metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES
Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate progression free survival overall survival and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate
Determine the toxicities of this treatment regimen in these patients
OUTLINE This is a multicenter study
Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8 Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to treatment prior to each course and then at 2 months after study completion
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-39 patients will be accrued for this study
Determine the efficacy of the combination of mitoxantrone and vinorelbine in terms of response rate progression free survival overall survival and quality of life in patients with metastatic hormone refractory adenocarcinoma of the prostate
Determine the toxicities of this treatment regimen in these patients
OUTLINE This is a multicenter study
Patients receive vinorelbine IV on days 1 and 8 and mitoxantrone IV on day 8 Treatment repeats every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity
Quality of life is assessed prior to treatment prior to each course and then at 2 months after study completion
Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-39 patients will be accrued for this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| EU-20025 | None | None | None |
| FRE-GERCOR-NONA-U98-1 | None | None | None |