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

March 7, 2000
October 1, 2003
June 19, 2013
June 1999
June 2002   (Final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00004922 on Archive Site
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Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors

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.


  • 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.

Phase 2
Primary Purpose: Treatment
  • Carcinoma of Unknown Primary
  • Neuroendocrine Carcinoma
  • Neuroendocrine Carcinoma of the Skin
Drug: irinotecan hydrochloride
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
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June 2002
June 2002   (Final data collection date for primary outcome measure)


  • 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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
United States
CDR0000067605 ( Registry Identifier: PDQ (Physician Data Query) )
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Memorial Sloan Kettering Cancer Center
National Cancer Institute (NCI)
Study Chair: Sunil Sharma, MD Memorial Sloan Kettering Cancer Center
Memorial Sloan Kettering Cancer Center
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP