Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
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.
Interventional
Primary Purpose: Treatment
Manisha H. Shah, MD
Study Chair
Ohio State University Comprehensive Cancer Center
United States: Federal Government
CDR0000068660
NCT00017199
April 2001
May 2007
Name | Location |
---|---|
University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |