Spots Global Cancer Trial Database for PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
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Trial Identification
Brief Title: PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
Official Title: Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
Study ID: NCT00017199
Interventions
Study Description
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 Description: 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Chicago Cancer Research Center, Chicago, Illinois, United States
Arthur G. James Cancer Hospital - Ohio State University, Columbus, Ohio, United States
Contact Details
Name: Manisha H. Shah, MD
Affiliation: Ohio State University Comprehensive Cancer Center
Role: STUDY_CHAIR
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