Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors

Conditions
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Carcinoma of Unknown Primary, Neuroendocrine Carcinoma, Neuroendocrine Carcinoma of the Skin

Intervention / Treatment
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* Drug: irinotecan hydrochloride


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: irinotecan hydrochloride|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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