Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003259
Status:
COMPLETED
Last Update Posted:
2019-06-26
First Post:
1999-11-01
Brief Title:
Vinorelbine in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Master Protocol for Metastatic Hormone-Resistant Prostatic Carcinoma Phase II Trials Protocol 4 Vinorelbine
Status:
COMPLETED
Status Verified Date:
2019-06
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
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial to study the effectiveness of vinorelbine in treating patients with metastatic prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Evaluate the efficacy of vinorelbine in patients with metastatic hormone-resistant prostate cancer II Evaluate the toxicity of vinorelbine in these patients III Evaluate the quality of life of these patients and correlate quality of life with PSA response
OUTLINE Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course Patients with stabilization of their disease partial response or complete response receive a maximum of 12 courses of treatment Patients showing disease progression or severe toxic side effects discontinue treatment Quality of life and pain are assessed prior to treatment at days 1 and 8 of each course and at end of the treatment Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-40 patients will be accrued for this study
OUTLINE Patients receive a 5-10 minute intravenous infusion of vinorelbine on day 1 and day 8 of a 21-day course Patients with stabilization of their disease partial response or complete response receive a maximum of 12 courses of treatment Patients showing disease progression or severe toxic side effects discontinue treatment Quality of life and pain are assessed prior to treatment at days 1 and 8 of each course and at end of the treatment Patients are followed every 3 months until disease progression
PROJECTED ACCRUAL A total of 14-40 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 |
|---|---|---|---|
| EU-97042 | None | None | None |
| SWS-SAKK-0897 | None | None | None |