PS-341 in Treating Patients With Metastatic Neuroendocrine Tumors

Inclusion 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