Ignite Creation Date:
2024-05-05 @ 9:27 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005096
Status:
COMPLETED
Last Update Posted:
2017-07-14
First Post:
2000-04-06
Brief Title:
Docetaxel in Treating Patients With Stage II or Stage III Prostate Cancer
Sponsor:
Dana-Farber Cancer Institute
Organization:
Dana-Farber Cancer Institute
Study Overview
Official Title:
Docetaxel Followed by Radical Prostatectomy in Patients With High Risk Localized Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-07
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
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer
PURPOSE Phase II trial to study the effectiveness of docetaxel in treating patients who have stage II or stage III prostate cancer
Detailed Description:
OBJECTIVES I Determine the pathologic complete response rate to docetaxel in patients with high risk stage II or III prostate cancer II Determine the toxicity of this treatment in these patients III Correlate clinical measures of response eg symptoms physical exam serum PSA and endorectal MRI with pathologic response to this treatment in these patients
OUTLINE Patients receive docetaxel IV over 30 minutes weekly for 4 weeks Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 19-45 patients will be accrued for this study over 18 months
OUTLINE Patients receive docetaxel IV over 30 minutes weekly for 4 weeks Treatment continues for 2-6 courses in the absence of disease progression or unacceptable toxicity
PROJECTED ACCRUAL A total of 19-45 patients will be accrued for this study over 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 |
|---|---|---|---|
| NCI-G00-1757 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA006516 |
| P30CA006516 | NIH | None | None |
| DFCI-99193 | None | None | None |