PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
|ClinicalTrials.gov Identifier: NCT00017199|
Recruitment Status : Completed
First Posted : February 16, 2004
Last Update Posted : January 31, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Gastrointestinal Carcinoid Tumor Islet Cell Tumor||Drug: bortezomib||Phase 2|
- 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 Type :||Interventional (Clinical Trial)|
|Official Title:||Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors|
|Study Start Date :||April 2001|
|Actual Study Completion Date :||May 2007|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00017199
|United States, Illinois|
|University of Chicago Cancer Research Center|
|Chicago, Illinois, United States, 60637-1470|
|United States, Ohio|
|Arthur G. James Cancer Hospital - Ohio State University|
|Columbus, Ohio, United States, 43210-1240|
|Study Chair:||Manisha H. Shah, MD||Ohio State University Comprehensive Cancer Center|