Ignite Creation Date:
2025-12-25 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 11:27 PM
Study NCT ID:
NCT00416793
Status:
TERMINATED
Last Update Posted:
2019-10-31
First Post:
2006-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
National Cancer Institute (NCI)
Organization:
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:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: