Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00031694
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2002-03-08
Brief Title:
Paclitaxel and Bryostatin 1 in Treating Patients With Advanced Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Sequential Paclitaxel and Bryostatin-1 for Patients With Advanced Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2021-05
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 locally advanced unresectable or metastatic pancreatic cancer Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Bryostatin-1 may help paclitaxel kill more cancer cells by making tumor cells more sensitive to the drug
Detailed Description:
PRIMARY OBJECTIVES
I To determine the response rates to weekly sequential paclitaxel bryostatin-1 in patients with unresectable and metastatic pancreatic cancer
II To determine the toxicity of therapy III To determine patient survival after therapy IV To determine Bryostatin-1 pharmacokinetics
OUTLINE This is an open-label multicenter study
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
I To determine the response rates to weekly sequential paclitaxel bryostatin-1 in patients with unresectable and metastatic pancreatic cancer
II To determine the toxicity of therapy III To determine patient survival after therapy IV To determine Bryostatin-1 pharmacokinetics
OUTLINE This is an open-label multicenter study
Patients receive paclitaxel IV over 1 hour on day 1 followed by bryostatin 1 IV over 1 hour on day 2 of weeks 1-3 Courses repeat every 4 weeks in the absence of disease progression or unacceptable toxicity
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 |
|---|---|---|---|
| N01CM17103 | NIH | CTEP | httpsreporternihgovquickSearchN01CM17103 |
| 01-09-224 | OTHER | None | None |
| NCI-5624 | OTHER | None | None |