NCT00017199

PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Ohio State University Comprehensive Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Carcinoid Tumor
• Islet Cell Tumor

Interventions

Type	Name	Description
DRUG	bortezomib

Timeline

• Start date: 2001-04-01
• Completion: 2007-05-01
• First posted: 2004-02-16
• Last updated: 2013-01-31

Locations

2 sites across 1 country: United States