PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
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|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|
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|