irinotecan in treating patients with advanced neuroendocrine tumors

Conditions: Carcinoma of Unknown Primary; Neuroendocrine Carcinoma; Neuroendocrine Carcinoma of the Skin

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 irinotecan in treating patients who have advanced neuroendocrine tumors.

objectives: * determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors. * evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population. outline: patients receive irinotecan iv over 90 minutes once weekly for 4 weeks. treatment repeats every 6 weeks in the absence of disease progression or unacceptable toxicity. patients are followed until death. projected accrual: a total of 10-31 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically proven metastatic or unresectable high grade neuroendocrine tumor including: * small cell carcinoma * large cell neuroendocrine carcinoma * other high grade neuroendocrine carcinomas without specification to cell size * no lung only involvement without any other primary site * no primary small cell lung cancer with or without metastases * bidimensionally measurable disease with at least one lesion measuring at least 1 cm by 1 cm * high grade tumor indicated by at least one of the following: * growth pattern suggestive of neuroendocrine differentiation * mitotic rate greater than 15 mitoses per 10 hpf * presence of abundant necrosis * immunohistochemical evidence of neuroendocrine differentiation by positive staining for chromogranin, synaptophysin, or neuron specific enolase if no classic microscopic appearance of small cell carcinoma * no low grade neuroendocrine tumors (e.g., carcinoid tumors, pancreatic endocrine tumors) and atypical tumors patient characteristics: age: * 18 and over performance status: * karnofsky 70-100% life expectancy: * not specified hematopoietic: * wbc at least 3,500/mm\^3 * granulocyte count at least 1,500/mm\^3 * platelet count at least 75,000/mm\^3 hepatic: * bilirubin no greater than upper limit of normal (uln) * sgot no greater than 5 times uln renal: * creatinine no greater than 2.0 mg/dl cardiovascular: * no myocardial infarction within the past 6 months * no uncontrolled congestive heart failure requiring therapy other: * no active or uncontrolled infection * hiv negative * no psychiatric or other disorder that would preclude study * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception prior concurrent therapy: biologic therapy * not specified chemotherapy * no more than 2 prior chemotherapy regimens * no prior camptothecins endocrine therapy * not specified radiotherapy * not specified surgery * not specified

Keywords: newly diagnosed carcinoma of unknown primary recurrent carcinoma of unknown primary stage iii neuroendocrine carcinoma of the skin recurrent neuroendocrine carcinoma of the skin neuroendocrine carcinoma