Ignite Creation Date:
2024-05-05 @ 10:17 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00005028
Status:
COMPLETED
Last Update Posted:
2019-11-04
First Post:
2000-04-06
Brief Title:
Paclitaxel and Bryostatin 1 in Treating Patients With Metastatic Prostate Cancer
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Phase II Study of Weekly Paclitaxel and Bryostatin-1 in Hormone Refractory Prostate Cancer
Status:
COMPLETED
Status Verified Date:
2019-10
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:
Phase II trial to study the effectiveness of combining paclitaxel and bryostatin 1 in treating patients who have metastatic prostate cancer that has not responded to hormone therapy 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
Detailed Description:
OBJECTIVES
I Determine the onset duration and degree of response in patients with hormone-refractory metastatic adenocarcinoma of the prostate treated with paclitaxel and bryostatin 1
II Determine the toxicity of this regimen in these patients III Determine the overall survival of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and bryostatin 1 IV over 1 hour on days 2 9 and 16 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months and then every 3 months thereafter
I Determine the onset duration and degree of response in patients with hormone-refractory metastatic adenocarcinoma of the prostate treated with paclitaxel and bryostatin 1
II Determine the toxicity of this regimen in these patients III Determine the overall survival of patients treated with this regimen
OUTLINE This is an open-label multicenter study
Patients receive paclitaxel IV over 1 hour on days 1 8 and 15 and bryostatin 1 IV over 1 hour on days 2 9 and 16 Treatment repeats every 4 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed monthly for 6 months and then every 3 months thereafter
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-50 | Registry Identifier | PDQ Physician Data Query | None |
| CDR0000067549 | REGISTRY | None | None |