Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00049257
Status:
COMPLETED
Last Update Posted:
2020-09-01
First Post:
2002-11-12
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:
Jonsson Comprehensive Cancer Center
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:
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-G02-2121 | None | None | None |
| UCLA-0202092 | None | None | None |
| BMS-UCLA-020209201 | None | None | None |