PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Phase 2

Completed

• Conditions: Gastrointestinal Carcinoid Tumor; Islet Cell Tumor

• Registration Number: NCT00017199
• Lead Sponsor: Ohio State University Comprehensive Cancer Center

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.

Study Timeline

• Study Start: 2001-04
• Study First Submitted: 2001-06-06
• Study First Submitted QC: 2004-02-13
• Study First Posted: 2004-02-16
• Status Verified: 2007-05
• Study Completion: 2007-05
• Last Update Submitted: 2013-01-30
• Last Update Posted: 2013-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: Not specified

Trial Locations

Locations (2)

Arthur G. James Cancer Hospital - Ohio State University; 🇺🇸 Columbus, Ohio, United States

University of Chicago Cancer Research Center; 🇺🇸 Chicago, Illinois, United States