Ignite Creation Date:
2024-05-05 @ 10:18 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00003781
Status:
COMPLETED
Last Update Posted:
2017-04-28
First Post:
1999-11-01
Brief Title:
Docetaxel in Treating Patients With Stage IV Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
Phase II Study of Weekly Docetaxel Taxotere in Hormone Refractory Metastatic Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2017-04
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
PURPOSE Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy
PURPOSE Phase II trial of docetaxel in treating patients who have stage IV prostate cancer that has not responded to hormone therapy
Detailed Description:
OBJECTIVES I Evaluate the efficacy of weekly docetaxel as measured by disease response strength and duration of pain reduction and either a decrease in analgesic use without an increase in pain or a decrease in PSA in patients with hormone refractory metastatic prostate cancer II Assess the efficacy of this regimen in terms of survival in this patient population III Evaluate the effect of this regimen on quality of life in these patients IV Determine qualitative and quantitative toxicities of this regimen in these patients
OUTLINE Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks Courses repeat every 8 weeks Therapy continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at weeks 1 3 5 and 7 of each course and a daily pain medication diary is maintained during treatment Patients are followed for 1 month or until resolution of toxicity then every 3 months until death
PROJECTED ACCRUAL A total of 25 patients will be accrued for this study
OUTLINE Patients receive docetaxel IV over 15-30 minutes weekly for 6 weeks Courses repeat every 8 weeks Therapy continues in the absence of disease progression or unacceptable toxicity Quality of life is assessed at weeks 1 3 5 and 7 of each course and a daily pain medication diary is maintained during treatment Patients are followed for 1 month or until resolution of toxicity then every 3 months until death
PROJECTED ACCRUAL A total of 25 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 |
|---|---|---|---|
| NCI-V99-1519 | None | None | None |
| OHSU-5134 | None | None | None |
| OCC-HOR-98037-L | None | None | None |
| RP-OHSU-5134 | None | None | None |