Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005048
Status:
COMPLETED
Last Update Posted:
2012-11-09
First Post:
2000-04-06
Brief Title:
Estramustine and Paclitaxel in Treating Patients With Prostate Cancer That Has Not Responded to Hormone Therapy
Sponsor:
NYU Langone Health
Organization:
NYU Langone Health
Study Overview
Official Title:
Safety and Efficacy of One Hour Weekly Taxol Infusion and Estramustine in Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2000-11
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 combining estramustine and paclitaxel in treating patients who have prostate cancer that has not responded to hormone therapy
PURPOSE Phase I trial to study the effectiveness of combining estramustine and paclitaxel in treating patients who have prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Determine the maximum tolerated dose MTD of paclitaxel with estramustine in patients with hormone refractory prostate cancer II Evaluate the toxicity of this combination at the MTD of paclitaxel in this patient population III Determine any objective tumor response arising from this treatment in these patients
OUTLINE This is a dose escalation study of paclitaxel Patients receive oral estramustine daily on days 1-3 and paclitaxel IV over 1 hour on day 3 weekly for 6 weeks followed by 1 week of rest Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A minimum of 18 patients will be accrued for this study within 18 months
OUTLINE This is a dose escalation study of paclitaxel Patients receive oral estramustine daily on days 1-3 and paclitaxel IV over 1 hour on day 3 weekly for 6 weeks followed by 1 week of rest Treatment continues for at least 2 courses in the absence of unacceptable toxicity or disease progression Cohorts of 3-6 patients receive escalating doses of paclitaxel until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 of 6 patients experience dose limiting toxicities
PROJECTED ACCRUAL A minimum of 18 patients will be accrued for this study within 18 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 |
|---|---|---|---|
| NYU-9715 | None | None | None |
| NCI-G00-1716 | None | None | None |