Ignite Creation Date:
2024-05-05 @ 11:23 AM
Last Modification Date:
2024-10-26 @ 9:06 AM
Study NCT ID:
NCT00017563
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
2001-06-06
Brief Title:
Combination Chemotherapy Followed by Surgery in Treating Patients With Localized Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase III Study of Neoadjuvant Weekly Docetaxel and Mitoxantrone Prior to Prostatectomy in Patients With High Risk Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
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 and giving chemotherapy before surgery may shrink the tumor so that it can be removed during surgery
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer
PURPOSE Phase III trial to study the effectiveness of combination chemotherapy followed by surgery in treating patients who have localized prostate cancer
Detailed Description:
OBJECTIVES
Determine the 5-year freedom from prostate-specific antigen PSA recurrence in patients treated with this regimen
Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by prostatectomy in patients with high-risk localized prostate cancer Phase I completed as of 21502
Determine the toxicity of this regimen in these patients
Determine the PSA response rate and pathologic response rate in patients treated with this regimen
Determine the clinical response in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the surgical margin status at time of prostatectomy in patients treated with this regimen
OUTLINE This is a dose-escalation study of mitoxantrone Phase I completed as of 21502
Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3 Treatment repeats once a week for a total of 4 courses
Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is determined Phase I completed as of 21502
Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy
PROJECTED ACCRUAL A total of 60 patients will be accrued for this study
Determine the 5-year freedom from prostate-specific antigen PSA recurrence in patients treated with this regimen
Define the maximum tolerated dose of neoadjuvant docetaxel and mitoxantrone followed by prostatectomy in patients with high-risk localized prostate cancer Phase I completed as of 21502
Determine the toxicity of this regimen in these patients
Determine the PSA response rate and pathologic response rate in patients treated with this regimen
Determine the clinical response in patients treated with this regimen
Determine the overall survival of patients treated with this regimen
Determine the surgical margin status at time of prostatectomy in patients treated with this regimen
OUTLINE This is a dose-escalation study of mitoxantrone Phase I completed as of 21502
Patients receive neoadjuvant docetaxel and mitoxantrone weekly on weeks 1-3 Treatment repeats once a week for a total of 4 courses
Patients receive escalating doses of mitoxantrone until the maximum tolerated dose is determined Phase I completed as of 21502
Patients undergo prostatectomy 2-4 weeks after completion of neoadjuvant chemotherapy
PROJECTED ACCRUAL A total of 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-G01-1962 | Other Identifier | OHSU IRB | None |
| OHSU-2794 | OTHER | None | None |
| OHSU-HOR-00037-L | None | None | None |