Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

Memorial Sloan Kettering Cancer Center

Overview

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.

Study Type

INTERVENTIONAL

Purpose

TREATMENT

Conditions

Carcinoma of Unknown Primary Neuroendocrine Carcinoma Neuroendocrine Carcinoma of the Skin

Interventions

irinotecan hydrochlorideDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, United States

Data from ClinicalTrials.gov

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