New York, New York 10021

  • Neuroendocrine Carcinoma of the Skin


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.

Study summary:

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.


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



Primary Contact:

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

Backup Contact:


Location Contact:

New York, New York 10021
United States

There is no listed contact information for this specific location.

Site Status: N/A

Data Source:

Date Processed: June 24, 2021

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.

Click to view Full Listing

This study is not currently recruiting Study Participants on The form below is not enabled.