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PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Primary Purpose

Gastrointestinal Carcinoid Tumor, Islet Cell Tumor

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bortezomib
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Gastrointestinal Carcinoid Tumor focused on measuring metastatic gastrointestinal carcinoid tumor, gastrinoma, insulinoma, somatostatinoma, glucagonoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed metastatic carcinoid tumor or islet cell tumor Well-differentiated neuroendocrine tumor OR Well-differentiated neuroendocrine carcinoma Measurable disease in at least 1 dimension At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following are considered nonmeasurable: Lesions in a previously irradiated area Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed Cystic lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Leukocyte count at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No other uncontrolled illness No ongoing active infection No psychiatric illness or social situation that would preclude study No history of allergic reaction to compounds of similar chemical or biologic composition to bortezomib Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy (interferon alfa) Chemotherapy: No more than 1 prior systemic chemotherapy regimen (except hepatic artery chemoembolization) At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas) At least 12 weeks since prior hepatic artery chemoembolization (unless liver lesions are not indicator lesions) Stable dose long-acting octreotide therapy (Sandostatin LAR) within the past 3 months allowed Concurrent subcutaneous octreotide for breakthrough symptomatic relief allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents, commercial agents, or therapies No concurrent combination antiretroviral therapy for HIV-positive patients

Sites / Locations

  • University of Chicago Cancer Research Center
  • Arthur G. James Cancer Hospital - Ohio State University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 6, 2001
Last Updated
January 30, 2013
Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00017199
Brief Title
PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
Official Title
Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2007
Overall Recruitment Status
Completed
Study Start Date
April 2001 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Ohio State University Comprehensive Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
Keywords
metastatic gastrointestinal carcinoid tumor, gastrinoma, insulinoma, somatostatinoma, glucagonoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
bortezomib

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed metastatic carcinoid tumor or islet cell tumor Well-differentiated neuroendocrine tumor OR Well-differentiated neuroendocrine carcinoma Measurable disease in at least 1 dimension At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan The following are considered nonmeasurable: Lesions in a previously irradiated area Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Lymphangitis cutis/pulmonis Abdominal masses that are not confirmed and followed Cystic lesions PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 6 months Hematopoietic: Leukocyte count at least 3,000/mm^3 Absolute neutrophil count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic: Bilirubin no greater than 1.5 mg/dL AST/ALT no greater than 2.5 times upper limit of normal Renal: Creatinine no greater than 1.5 mg/dL Cardiovascular: No symptomatic congestive heart failure No unstable angina pectoris No cardiac arrhythmia Other: No other uncontrolled illness No ongoing active infection No psychiatric illness or social situation that would preclude study No history of allergic reaction to compounds of similar chemical or biologic composition to bortezomib Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: At least 4 weeks since prior immunotherapy (interferon alfa) Chemotherapy: No more than 1 prior systemic chemotherapy regimen (except hepatic artery chemoembolization) At least 4 weeks since prior systemic chemotherapy (6 weeks for nitrosoureas) At least 12 weeks since prior hepatic artery chemoembolization (unless liver lesions are not indicator lesions) Stable dose long-acting octreotide therapy (Sandostatin LAR) within the past 3 months allowed Concurrent subcutaneous octreotide for breakthrough symptomatic relief allowed Endocrine therapy: Not specified Radiotherapy: See Disease Characteristics At least 4 weeks since prior radiotherapy Surgery: Not specified Other: No other concurrent investigational agents, commercial agents, or therapies No concurrent combination antiretroviral therapy for HIV-positive patients
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha H. Shah, MD
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Arthur G. James Cancer Hospital - Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210-1240
Country
United States

12. IPD Sharing Statement

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PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

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