Gastrointestinal Carcinoid Tumor Clinical Trial
Official title:
Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
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.
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.
;
Primary Purpose: Treatment
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