COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00004922
Recruitment Status : Completed
First Posted : October 1, 2003
Last Update Posted : June 19, 2013
National Cancer Institute (NCI)
Information provided by:
Memorial Sloan Kettering Cancer Center

Brief Summary:

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 or disease Intervention/treatment Phase
Carcinoma of Unknown Primary Neuroendocrine Carcinoma Neuroendocrine Carcinoma of the Skin Drug: irinotecan hydrochloride Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Primary Purpose: Treatment
Official Title: A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors
Study Start Date : June 1999
Actual Primary Completion Date : June 2002
Actual Study Completion Date : June 2002

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00004922

Layout table for location information
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)
Layout table for investigator information
Study Chair: Sunil Sharma, MD Memorial Sloan Kettering Cancer Center
Layout table for additonal information Identifier: NCT00004922    
Other Study ID Numbers: 99-041
CDR0000067605 ( Registry Identifier: PDQ (Physician Data Query) )
First Posted: October 1, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 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:
Layout table for MeSH terms
Carcinoma, Merkel Cell
Neuroendocrine Tumors
Carcinoma, Neuroendocrine
Neoplasms, Unknown Primary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neoplasm Metastasis
Neoplastic Processes
Pathologic Processes
Polyomavirus Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections
Topoisomerase I Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents