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Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

This study has been completed.
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center Identifier:
First received: March 7, 2000
Last updated: June 18, 2013
Last verified: June 2013

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 Intervention Phase
Carcinoma of Unknown Primary
Neuroendocrine Carcinoma
Neuroendocrine Carcinoma of the Skin
Drug: irinotecan hydrochloride
Phase 2

Study Type: Interventional
Study Design: Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors

Resource links provided by NLM:

Further study details as provided by Memorial Sloan Kettering Cancer Center:

Study Start Date: June 1999
Study Completion Date: June 2002
Primary Completion Date: June 2002 (Final data collection date for primary outcome measure)
Detailed Description:


  • 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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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



  • 18 and over

Performance status:

  • Karnofsky 70-100%

Life expectancy:

  • Not specified


  • WBC at least 3,500/mm^3
  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 75,000/mm^3


  • Bilirubin no greater than upper limit of normal (ULN)
  • SGOT no greater than 5 times ULN


  • Creatinine no greater than 2.0 mg/dL


  • No myocardial infarction within the past 6 months
  • No uncontrolled congestive heart failure requiring therapy


  • 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


Biologic therapy

  • Not specified


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

Endocrine therapy

  • Not specified


  • Not specified


  • Not specified
  Contacts and Locations
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Please refer to this study by its identifier: NCT00004922

United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sunil Sharma, MD Memorial Sloan Kettering Cancer Center
  More Information Identifier: NCT00004922     History of Changes
Other Study ID Numbers: 99-041
CDR0000067605 ( Registry Identifier: PDQ (Physician Data Query) )
Study First Received: March 7, 2000
Last Updated: June 18, 2013

Keywords provided by Memorial Sloan Kettering Cancer Center:
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

Additional relevant MeSH terms:
Neuroendocrine Tumors
Carcinoid Tumor
Carcinoma, Neuroendocrine
Skin Neoplasms
Neoplasms, Unknown Primary
Carcinoma, Merkel Cell
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasms by Site
Skin Diseases
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors processed this record on April 26, 2017