Gastrointestinal Carcinoid Tumor, Islet Cell Tumor
Conditions
Keywords
metastatic gastrointestinal carcinoid tumor, gastrinoma, insulinoma, somatostatinoma, glucagonoma
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.
Interventions
DRUGbortezomib
Sponsors
National Cancer Institute (NCI)
Ohio State University Comprehensive Cancer Center
Study design
Primary purpose
TREATMENT
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Countries
United States
Outcome results
None listed