Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-30 @ 1:06 AM
Study NCT ID:
NCT00049257
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2002-11-12
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Paclitaxel and Carboplatin in Treating Patients With Metastatic Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Jonsson Comprehensive Cancer Center
Organization:
Study Overview
Official Title:
A Phase II Trial of Paclitaxel and Carboplatin in the Treatment of Hormone-Refractory Prostate Cancer (HRPC)
Status:
COMPLETED
Status Verified Date:
2012-08
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.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
PURPOSE: Phase II trial to study the effectiveness of combining paclitaxel with carboplatin in treating patients who have metastatic prostate cancer that has not responded to hormone therapy.
Detailed Description:
OBJECTIVES:
* Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin.
* Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen.
* Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
* Determine the prostate-specific antigen (PSA) response rate and time to PSA progression in patients with metastatic hormone-refractory prostate cancer treated with paclitaxel and carboplatin.
* Determine the objective response rate, time to measurable or evaluable disease progression, and overall survival in patients treated with this regimen.
* Determine the safety and toxicity of this regimen in these patients.
OUTLINE: This is an open-label study.
Patients receive paclitaxel IV on days 1, 8, and 15 and carboplatin IV on day 1. Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity.
Patients are followed every 4 weeks for 12 weeks and then every 2 months thereafter.
PROJECTED ACCRUAL: Approximately 60 patients will be accrued for this study.
Study Oversight
Has Oversight DMC:
True
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?: