Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003622
Status:
WITHDRAWN
Last Update Posted:
2017-07-13
First Post:
1999-11-01
Brief Title:
Vinorelbine Plus Paclitaxel in Treating Patients With Metastatic Prostate Cancer That Is Refractory to Hormone Therapy
Sponsor:
James Ahlgren
Organization:
George Washington University
Study Overview
Official Title:
Phase II Study of Vinorelbine With Paclitaxel in the Treatment of Hormone-Refractory Prostate Cancer
Status:
WITHDRAWN
Status Verified Date:
2017-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
No recruitment
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
PURPOSE Phase II trial to study the effectiveness of vinorelbine plus paclitaxel in treating patients with metastatic prostate cancer that is refractory to hormone therapy
PURPOSE Phase II trial to study the effectiveness of vinorelbine plus paclitaxel in treating patients with metastatic prostate cancer that is refractory to hormone therapy
Detailed Description:
OBJECTIVES I Determine the clinical benefit response including improvement in quality of life of vinorelbine and paclitaxel in patients with metastatic hormone-refractory prostate cancer II Correlate PSA response with clinical benefit response in these patients III Determine the objective response rate and duration of remission in patients with measurable disease treated with this regimen IV Further assess the toxicity of this combination in a cohort of prostate cancer patients V Examine the survival characteristics of these patients undergoing this regimen
OUTLINE This an open label study Patients receive vinorelbine IV over 6-10 minutes on days 1 2 and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine Course repeats every 28 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed before each treatment course Patients are followed until death
PROJECTED ACCRUAL A total of 30 patients will be accrued into this study over 15-30 months
OUTLINE This an open label study Patients receive vinorelbine IV over 6-10 minutes on days 1 2 and 3 and paclitaxel IV over 3 hours on day 3 following vinorelbine Course repeats every 28 days in the absence of disease progression or unacceptable toxicity Quality of life is assessed before each treatment course Patients are followed until death
PROJECTED ACCRUAL A total of 30 patients will be accrued into this study over 15-30 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 |
|---|---|---|---|
| NCI-V98-1486 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000066701 | REGISTRY | None | None |
| GW-GWCC-4097 | None | None | None |