PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Phase II Study of PS-341 in Metastatic Neuroendocrine Tumors

Conditions
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Gastrointestinal Carcinoid Tumor, Islet Cell Tumor

Intervention / Treatment
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* Drug: bortezomib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bortezomib|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metastatic gastrointestinal carcinoid tumor, gastrinoma, insulinoma, somatostatinoma, glucagonoma