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Irinotecan in Treating Patients With Advanced Neuroendocrine Tumors
This study has been completed.
First Received: March 7, 2000   Last Updated: July 23, 2008   History of Changes
Sponsors and Collaborators: Memorial Sloan-Kettering Cancer Center
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00004922
  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.


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

MedlinePlus related topics: Cancer
Drug Information available for: Irinotecan U 101440E Irinotecan hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment
Official Title: A Phase II Clinical Trial of Irinotecan (CPT-11) in Patients With Advanced High Grade Neuroendocrine Tumors

Further study details as provided by National Cancer Institute (NCI):

Study Start Date: June 1999
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004922

Locations
United States, New York
Memorial Sloan-Kettering Cancer Center
New York, New York, United States, 10021
Sponsors and Collaborators
Memorial Sloan-Kettering Cancer Center
Investigators
Study Chair: Sunil Sharma, MD Memorial Sloan-Kettering Cancer Center
  More Information

Additional Information:
No publications provided

Study ID Numbers: CDR0000067605, MSKCC-99041, NCI-G00-1683
Study First Received: March 7, 2000
Last Updated: July 23, 2008
ClinicalTrials.gov Identifier: NCT00004922     History of Changes
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
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

Study placed in the following topic categories:
Neoplasms, Unknown Primary
Skin Diseases
Carcinoma, Neuroendocrine
Carcinoma, Basosquamous
Irinotecan
Carcinoma, Basal Cell
Skin Neoplasms
Camptothecin
Recurrence
Carcinoma
Neuroendocrine Tumors
Carcinoma, Merkel Cell
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neuroepithelioma
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Adenocarcinoma
Carcinoma, Squamous Cell
Antineoplastic Agents, Phytogenic
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Molecular Mechanisms of Pharmacological Action
Carcinoma, Basosquamous
Carcinoma, Neuroendocrine
Antineoplastic Agents
Neoplasms, Nerve Tissue
Irinotecan
Neoplastic Processes
Pathologic Processes
Neoplasms by Site
Therapeutic Uses
Neoplasms, Germ Cell and Embryonal
Neoplasm Metastasis
Neoplasms, Basal Cell
Neoplasms, Squamous Cell
Neoplasms, Unknown Primary
Neoplasms by Histologic Type
Skin Diseases
Enzyme Inhibitors
Carcinoma, Basal Cell
Skin Neoplasms
Pharmacologic Actions
Camptothecin
Neuroendocrine Tumors
Carcinoma
Carcinoma, Merkel Cell
Neuroectodermal Tumors
Neoplasms
Carcinoma, Squamous Cell
Adenocarcinoma
Antineoplastic Agents, Phytogenic

ClinicalTrials.gov processed this record on May 07, 2009