Ignite Creation Date:
2024-05-05 @ 5:26 PM
Last Modification Date:
2024-10-26 @ 9:32 AM
Study NCT ID:
NCT00459810
Status:
TERMINATED
Last Update Posted:
2017-04-28
First Post:
2007-04-11
Brief Title:
Paclitaxel Poliglumex and Estradiol in Treating Patients With Stage IV Prostate Cancer
Sponsor:
OHSU Knight Cancer Institute
Organization:
OHSU Knight Cancer Institute
Study Overview
Official Title:
A Phase II Study of Paclitaxel Poliglumex PPX in Combination With Transdermal Estradiol for the Treatment of Androgen Independent Prostate Cancer After Docetaxel Chemotherapy
Status:
TERMINATED
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 such as paclitaxel poliglumex work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Estradiol may kill prostate cancer cells that no longer respond to hormone therapy Giving paclitaxel poliglumex together with estradiol may kill more tumor cells
PURPOSE This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer
PURPOSE This phase II trial is studying how well giving paclitaxel poliglumex together with estradiol works in treating patients with stage IV prostate cancer
Detailed Description:
OBJECTIVES
Primary
Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol
Secondary
Determine the toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
Determine the time to PSA progression and measurable disease progression in patients treated with this regimen
Determine time to death from all causes in patients treated with this regimen
Correlate levels of serum estradiol serum cathepsin B and bone turnover markers with PSA response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive transdermal estradiol continuously patches changed every 7 days until the PSA level rises Patients whose PSA increases above baseline or PSA decreases 10 after 4 weeks of estradiol therapy or whose serum PSA reduction is 50 after 12 weeks of estradiol therapy also receive paclitaxel poliglumex therapy These patients receive paclitaxel poliglumex IV over 10-20 minutes on day 1 Treatment with paclitaxel poliglumex repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 6 months
PROJECTED ACCRUAL A total of 50 patients will be accrued for this study
Primary
Determine the PSA response rate in patients with androgen independent metastatic prostate cancer treated with paclitaxel poliglumex and transdermal estradiol
Secondary
Determine the toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
Determine the time to PSA progression and measurable disease progression in patients treated with this regimen
Determine time to death from all causes in patients treated with this regimen
Correlate levels of serum estradiol serum cathepsin B and bone turnover markers with PSA response in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive transdermal estradiol continuously patches changed every 7 days until the PSA level rises Patients whose PSA increases above baseline or PSA decreases 10 after 4 weeks of estradiol therapy or whose serum PSA reduction is 50 after 12 weeks of estradiol therapy also receive paclitaxel poliglumex therapy These patients receive paclitaxel poliglumex IV over 10-20 minutes on day 1 Treatment with paclitaxel poliglumex repeats every 28 days for up to 10 courses in the absence of disease progression or unacceptable toxicity
After completion of study therapy patients are followed every 6 months
PROJECTED ACCRUAL A total of 50 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 |
|---|---|---|---|
| OHSU-2656 | OTHER | OHSU IRB | None |