Clinical Trial: PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
Brief Summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.
PURPOSE: Phase II trial to study the effectiveness of PS-341 in treating patients who have metastatic neuroendocrine tumors.
Detailed Summary:
OBJECTIVES:
- Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with bortezomib.
- Determine the toxicity of this drug in this patient population.
- Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population.
OUTLINE: This is a multicenter study.
Patients receive bortezomib IV over 3-5 seconds on days 1, 4, 8, and 11. Treatment repeats every 21 days for at least 8 courses in the absence of disease progression or unacceptable toxicity. Patients achieving complete response (CR) receive 2 additional courses beyond CR.
PROJECTED ACCRUAL: A total of 16-25 patients will be accrued for this study within 6 months.
Sponsor: Ohio State University Comprehensive Cancer Center
Current Primary Outcome:
Original Primary Outcome:
Current Secondary Outcome:
Original Secondary Outcome:
Information By: National Cancer Institute (NCI)
Dates:
Date Received: June 6, 2001
Date Started: April 2001
Date Completion:
Last Updated: January 30, 2013
Last Verified: May 2007
