NCT00416793

Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer

A Phase II Study of Bortezomib in Combination With Carboplatin in Patients With Metastatic Pancreatic Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acinar Cell Adenocarcinoma of the Pancreas
• Duct Cell Adenocarcinoma of the Pancreas
• Stage IV Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	bortezomib	Given IV
DRUG	carboplatin	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2006-12-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2006-12-28
• Last updated: 2019-10-31
• Results posted: 2011-07-15

Locations

1 site across 1 country: United States