Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:03 AM
Study NCT ID:
NCT00002775
Status:
UNKNOWN
Last Update Posted:
2014-01-06
First Post:
1999-11-01
Brief Title:
Docetaxel Plus Estramustine in Treating Patients With Metastatic Prostate Cancer
Sponsor:
Herbert Irving Comprehensive Cancer Center
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
PHASE III STUDY OF DOCETAXEL TAXOTERE AND ESTRAMUSTINE COMBINATION CHEMOTHERAPY IN PATIENTS WITH PROSTATE CANCER
Status:
UNKNOWN
Status Verified Date:
2000-04
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 Phase III trial to study the effectiveness of combining docetaxel and estramustine in treating patients who have metastatic prostate cancer
PURPOSE Phase III trial to study the effectiveness of combining docetaxel and estramustine in treating patients who have metastatic prostate cancer
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose toxicity and pharmacokinetic profile of docetaxel in combination with estramustine in patients with metastatic adenocarcinoma of the prostate II Determine the safe dose level of this regimen for Phase II evaluation III Determine the efficacy of this regimen with evaluation of objective response rate duration of response and time to disease progression in these patients IV Determine the duration of survival of these patients on this regimen V Evaluate the symptomatic and quality of life effects in these patients
OUTLINE This is a dose escalation study phase I Patients are stratified into one of two risk groups by number of prior chemotherapy regimens 0-2 vs greater than 2 and occurrence and sites of prior radiation Patients receive oral estramustine three times daily beginning 24 hours prior to docetaxel and continuing for 4 days after infusion Patients receive docetaxel IV over 1 hour every 21 days Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is reached phase I The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity A minimum of 6 patients receive treatment at the MTD Phase II Patients receive docetaxel IV at the MTD from phase I Treatment continues in the absence of disease progression or unacceptable toxicity for both phases Quality of life is assessed Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 12-37 patients will be accrued for this study within 13-19 months
OUTLINE This is a dose escalation study phase I Patients are stratified into one of two risk groups by number of prior chemotherapy regimens 0-2 vs greater than 2 and occurrence and sites of prior radiation Patients receive oral estramustine three times daily beginning 24 hours prior to docetaxel and continuing for 4 days after infusion Patients receive docetaxel IV over 1 hour every 21 days Cohorts of 3-6 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is reached phase I The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicity A minimum of 6 patients receive treatment at the MTD Phase II Patients receive docetaxel IV at the MTD from phase I Treatment continues in the absence of disease progression or unacceptable toxicity for both phases Quality of life is assessed Patients are followed every 3 months until death
PROJECTED ACCRUAL Approximately 12-37 patients will be accrued for this study within 13-19 months
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-V96-0888 | None | None | None |
| CPMC-IRB-7386 | None | None | None |