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Home > "P" Clinical Trials Conditions > PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors  PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
For Condition: Glucagonoma,Gastrinoma,Insulinoma,miscellaneous islet cell cancer,metastatic gastrointestinal carcinoid tumor,Somatostatinoma
Status: Completed
Sponsor(s): National Cancer Institute (NCI) , Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Synopsis: 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.
Details: OBJECTIVES: I. Determine the objective response rate of patients with metastatic neuroendocrine tumors treated with PS-341. II. Determine the toxicity of this drug in this patient population. III. Determine the pharmacodynamics to correlate proteasome inhibition and efficacy of this drug in this patient population. PROTOCOL OUTLINE: This is a multicenter study. Patients receive PS-341 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:
Study Type: Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders:
Protocol Entry Criteria: PROTOCOL ENTRY 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 --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 --Patient Characteristics-- - Age: 18 and over - Performance status: ECOG 0-2 - Life expectancy: At least 6 months - Hematopoietic: Leukocyte count at least 3,000/mm3; Absolute neutrophil count at least 1,500/mm3; Platelet count at least 100,000/mm3 - 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 PS-341; Not pregnant or nursing; Negative pregnancy test; Fertile patients must use effective contraception
Total Enrollment:
Location and Contact Information:
Overall Study Official:
ManishaShah, Study Chair, Arthur G. James Cancer Hospital & Richard J. Solove Research Institute
Arthur G. James Cancer Hospital - Ohio State University
Columbus, Ohio, 43210-1240
United States
University of Chicago Cancer Research Center
Chicago, Illinois, 60637-1470
United States
Additional Information:
Study ID Numbers: CDR0000068660; NCI-1856,OSU-00H0328
Study Start Date: April 2001
Record last reviewed: February 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00017199
Other Somatostatinoma Studies:
1. Laparoscopy to Remove Pancreatic Tumors (Insulinomas)
2. PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
3. Diagnosing and Treating Low Blood Sugar Levels
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PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors
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