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.

Condition	Treatment or Intervention	Phase
newly diagnosed carcinoma of unknown primary Neuroendocrine Carcinoma recurrent carcinoma of unknown primary stage III Merkel cell carcinoma recurrent Merkel cell carcinoma	Procedure: chemotherapy  Drug: irinotecan	Phase II

Further Study Details: 

OBJECTIVES: I. Determine the efficacy of irinotecan in terms of tumor response, time to tumor progression, and survival in patients with advanced high grade neuroendocrine tumors. II. Evaluate the dose limiting and nondose limiting toxicities of this treatment regimen in this patient population.

PROTOCOL 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.

Ages Eligible for Study:  18 Years and above

Criteria

PROTOCOL ENTRY 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

--Prior/Concurrent Therapy--

• No more than 2 prior chemotherapy regimens
• No prior camptothecins

--Patient Characteristics--

• Age: 18 and over
• Performance status: Karnofsky 70-100%
• Life expectancy: Not specified
• Hematopoietic: WBC at least 3,500/mm3; Granulocyte count at least 1,500/mm3; Platelet count at least 75,000/mm3
• 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

New York
      Memorial Sloan-Kettering Cancer Center, New York,  New York,  10021,  United States

Study chairs or principal investigators

Sunil Sharma,  Study Chair,  Memorial Sloan-Kettering Cancer Center   

Study ID Numbers:  CDR0000067605; MSKCC-99041; NCI-G00-1683
Record last reviewed:  September 2003
Last Updated:  October 13, 2004
Record first received:  March 7, 2000
ClinicalTrials.gov Identifier:  NCT00004922
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08