Expired Study
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New York, New York 10021


Purpose:

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.


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


NCT ID:

NCT00004922


Primary Contact:

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


Backup Contact:

N/A


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: ClinicalTrials.gov

Date Processed: September 23, 2017

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