Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00416793
Status:
TERMINATED
Last Update Posted:
2019-10-31
First Post:
2006-12-27
Brief Title:
Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer
Status:
TERMINATED
Status Verified Date:
2019-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to poor accrual
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This phase II trial is studying how well giving bortezomib together with carboplatin works in treating patients with metastatic pancreatic cancer Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving bortezomib together with carboplatin may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I To evaluate overall survival OS at 6 months with the combination of bortezomib and carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic cancer
SECONDARY OBJECTIVES
I To evaluate the objective tumor response rate the duration of response time to tumor progression and overall survival
II To evaluate biological effects on peripheral blood mononuclear cells III To evaluate the safety profile of this combination IV To evaluate archival tissue for epithelial-to-mesenchymal transition EMT and E-cadherin and Zeb-1
OUTLINE
Patients receive bortezomib intravenously IV on days 1 4 8 and 11 and carboplatin intravenously IV over 30 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
I To evaluate overall survival OS at 6 months with the combination of bortezomib and carboplatin in patients who previously received 1 prior regimen for metastatic pancreatic cancer
SECONDARY OBJECTIVES
I To evaluate the objective tumor response rate the duration of response time to tumor progression and overall survival
II To evaluate biological effects on peripheral blood mononuclear cells III To evaluate the safety profile of this combination IV To evaluate archival tissue for epithelial-to-mesenchymal transition EMT and E-cadherin and Zeb-1
OUTLINE
Patients receive bortezomib intravenously IV on days 1 4 8 and 11 and carboplatin intravenously IV over 30 minutes on day 1 Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
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 |
|---|---|---|---|
| 7752 | OTHER | CTEP | None |
| NCI-2012-02894 | REGISTRY | None | None |
| CDR0000522739 | None | None | None |
| NO1-CM-17003-74 | None | None | None |
| MDA-2006-0079 | OTHER | None | None |