Ignite Creation Date:
2024-05-05 @ 5:34 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00482274
Status:
TERMINATED
Last Update Posted:
2017-04-28
First Post:
2007-06-04
Brief Title:
Docetaxel in Treating Patients With Relapsed Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase II Study of the Early Use of Docetaxel in Patients With Biochemical Relapse After Primary Therapy for Prostate Cancer and an Incomplete Response to Androgen Deprivation Therapy
Status:
TERMINATED
Status Verified Date:
2017-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Drug supplier stopped funding due to loss of study drug docetaxel patent
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 such as docetaxel work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing
PURPOSE This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer
PURPOSE This phase II trial is studying how well docetaxel works in treating patients with relapsed prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the complete response rate in patients with biochemically-relapsed hormone-sensitive prostate cancer treated with docetaxel
Secondary
Determine the time to PSA recurrence in patients receiving this treatment
Determine the time to metastatic disease in patients receiving this treatment
Determine the time to androgen independent state in patients receiving this treatment
Determine the time to death from any cause in patients receiving this treatment
OUTLINE This is an open label study
Patients receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression
After completion of study therapy patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
Primary
Determine the complete response rate in patients with biochemically-relapsed hormone-sensitive prostate cancer treated with docetaxel
Secondary
Determine the time to PSA recurrence in patients receiving this treatment
Determine the time to metastatic disease in patients receiving this treatment
Determine the time to androgen independent state in patients receiving this treatment
Determine the time to death from any cause in patients receiving this treatment
OUTLINE This is an open label study
Patients receive docetaxel IV over 60 minutes on day 1 Treatment repeats every 21 days for 4-6 courses in the absence of unacceptable toxicity or disease progression
After completion of study therapy patients are followed periodically for up to 5 years
PROJECTED ACCRUAL A total of 36 patients will be accrued for this study
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 |
|---|---|---|---|
| P30CA069533 | NIH | None | None |
| OHSU-2838 | OTHER | None | None |
| OHSU-SOL-06076-LM | OTHER | OHSU Knight Cancer Institute | httpsreporternihgovquickSearchP30CA069533 |