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| Sponsors and Collaborators: |
Arthur G. James Cancer Hospital & Richard J. Solove Research Institute National Cancer Institute (NCI) |
| Information provided by: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00017199 |
Purpose
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 | Intervention | Phase |
|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor |
Drug: bortezomib |
Phase II |
| MedlinePlus related topics: | Cancer Carcinoid Tumors |
| Drug Information available for: | Bortezomib |
| Study Type: | Interventional |
| Study Design: | Treatment |
| Official Title: | Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors |
| Study Start Date: | April 2001 |
OBJECTIVES:
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.
Eligibility
| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic carcinoid tumor or islet cell tumor
Measurable disease in at least 1 dimension
The following are considered nonmeasurable:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
Contacts and Locations| 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 | |||||
| Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
| National Cancer Institute (NCI) |
| Study Chair: | Manisha H. Shah, MD | Arthur G. James Cancer Hospital & Richard J. Solove Research Institute |
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database 
  |
| Study ID Numbers: | CDR0000068660, OSU-00H0328, NCI-1856 |
| First Received: | June 6, 2001 |
| Last Updated: | July 23, 2008 |
| ClinicalTrials.gov Identifier: | NCT00017199 |
| Health Authority: | United States: Federal Government |
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