Clinical Trial: Bortezomib and Carboplatin in Treating Patients With Metastatic Pancreatic Cancer

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: National Cancer Institute (NCI)

Current Primary Outcome: Overall Survival Rate at 6 Months [ Time Frame: up to 6 months ]

Overall survival (OS) at 6 months with the combination of bortezomib and carboplatin in participants who previously received 1 prior regimen for metastatic pancreatic cancer from date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 6 months. Rate equals number of participants living at 6 months following treatment divided by the total number of participants.


Original Primary Outcome: Overall survival at 6 months

Current Secondary Outcome: Overall Response Rate [ Time Frame: Evaluated at end of every second 3 week cycle for response ]

Overall Response Rate measured by number of patients per the total treatment population who partially or completely responded to treatment. Participants reevaluated for response every 6 weeks. In addition to a baseline scan, confirmatory scans at 4 weeks following initial documentation of objective response.


Original Secondary Outcome:

  • Overall Response Rate
  • Duration of response
  • Time to disease progression
  • Overall survival
  • Toxicity and safety


Information By: National Cancer Institute (NCI)

Dates:
Date Received: December 27, 2006
Date Started: December 2006
Date Completion:
Last Updated: May 12, 2014
Last Verified: October 2013