Ignite Creation Date:
2024-05-05 @ 11:22 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005627
Status:
COMPLETED
Last Update Posted:
2013-07-18
First Post:
2000-05-02
Brief Title:
Estramustine Docetaxel and Carboplatin in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
Dana-Farber Cancer Institute
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase I Study of Estramustine Taxotere and Carboplatin ETP in Patients With Horomone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2003-04
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 may kill more tumor cells
PURPOSE Phase I trial to study the effectiveness of estramustine docetaxel and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy
PURPOSE Phase I trial to study the effectiveness of estramustine docetaxel and carboplatin in treating patients who have prostate cancer that has not responded to hormonal therapy
Detailed Description:
OBJECTIVES
Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer
Determine the safety and efficacy of this regimen in this patient population
OUTLINE This is a dose escalation study of docetaxel
Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3 Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 12 months
Determine the maximum tolerated dose of weekly docetaxel when combined with carboplatin and estramustine in patients with hormone refractory prostate cancer
Determine the safety and efficacy of this regimen in this patient population
OUTLINE This is a dose escalation study of docetaxel
Patients receive oral estramustine 3 times daily on days 1-5 and docetaxel IV over 1 hour on day 2 of weeks 1-3 Patients also receive carboplatin IV over 1 hour on day 2 of week 1 only Treatment continues every 28 days for up to 6 courses in the absence of unacceptable toxicity or disease progression
Cohorts of 3-5 patients receive escalating doses of docetaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 5 patients experience dose-limiting toxicity
PROJECTED ACCRUAL A total of 20-30 patients will be accrued for this study within 12 months
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 |
|---|---|---|---|
| NCI-G00-1779 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067775 | REGISTRY | None | None |
| RP-DFCI-98238 | None | None | None |