Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00003633
Status:
UNKNOWN
Last Update Posted:
2013-12-19
First Post:
1999-11-01
Brief Title:
Combination Chemotherapy in Treating Patients With Advanced Prostate Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Treatment of Prostate Cancer by Induction of Alternate Cell Death Pathways A Phase I Trial of Docetaxel Estramustine Mitoxantrone and Prednisone
Status:
UNKNOWN
Status Verified Date:
2005-03
Last Known Status:
ACTIVE_NOT_RECRUITING
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 This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced prostate cancer
PURPOSE This phase I trial is studying the side effects and best dose of combination chemotherapy in treating patients with advanced prostate cancer
Detailed Description:
OBJECTIVES
Determine the maximum tolerated doses of docetaxel and mitoxantrone in combination with a fixed dose of estramustine and prednisone when given to patients with advanced prostate cancer
Characterize the toxicity of this treatment regimen in these patients
OUTLINE This is a dose escalation study of mitoxantrone and docetaxel Patients are stratified into one of two risk groups good risk group or poor risk group based on the number of prior chemotherapy regimens and the occurrence and sitess of prior radiation
All patients receive oral prednisone twice daily on days 0-3 oral estramustine three times daily on days 1-5 mitoxantrone IV bolus on day 2 and docetaxel IV over 1 hour on day 2 Courses repeat every 21 days in the absence of unacceptable toxicity and disease progression Patients with stable disease may go off treatment after 6 courses
Dose escalation proceeds independently for each risk group Cohorts of 3 patients are entered into each risk group If 1 of 3 patients at a dose level experiences dose limiting toxicity DLT then 3 additional patients are accrued into this level If 2 of 6 patients at a dose level experience DLT then dose escalation stops and the maximum tolerated dose MTD is defined at the previous dose level At least 6 patients must be treated at the MTD
Patients are followed every 3 months until death
PROJECTED ACCRUAL At least 12 patients 6 in each risk group will be accrued into this study
Determine the maximum tolerated doses of docetaxel and mitoxantrone in combination with a fixed dose of estramustine and prednisone when given to patients with advanced prostate cancer
Characterize the toxicity of this treatment regimen in these patients
OUTLINE This is a dose escalation study of mitoxantrone and docetaxel Patients are stratified into one of two risk groups good risk group or poor risk group based on the number of prior chemotherapy regimens and the occurrence and sitess of prior radiation
All patients receive oral prednisone twice daily on days 0-3 oral estramustine three times daily on days 1-5 mitoxantrone IV bolus on day 2 and docetaxel IV over 1 hour on day 2 Courses repeat every 21 days in the absence of unacceptable toxicity and disease progression Patients with stable disease may go off treatment after 6 courses
Dose escalation proceeds independently for each risk group Cohorts of 3 patients are entered into each risk group If 1 of 3 patients at a dose level experiences dose limiting toxicity DLT then 3 additional patients are accrued into this level If 2 of 6 patients at a dose level experience DLT then dose escalation stops and the maximum tolerated dose MTD is defined at the previous dose level At least 6 patients must be treated at the MTD
Patients are followed every 3 months until death
PROJECTED ACCRUAL At least 12 patients 6 in each risk group will be accrued into this study
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CPMC-IRB-AAAA5741 | None | None | None |
| CPMC-IRB-8040 | None | None | None |
| CPMC-IRB-8040-29173 | None | None | None |
| NCI-V98-1487 | None | None | None |