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Sponsors and Collaborators: |
Memorial Sloan-Kettering Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00004922 |
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 |
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Carcinoma of Unknown Primary Neuroendocrine Carcinoma Neuroendocrine Carcinoma of the Skin |
Drug: irinotecan hydrochloride |
Phase II |
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 |
Study Start Date: | June 1999 |
OBJECTIVES:
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 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically proven metastatic or unresectable high grade neuroendocrine tumor including:
High grade tumor indicated by at least one of the following:
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Cardiovascular:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, New York | |
Memorial Sloan-Kettering Cancer Center | |
New York, New York, United States, 10021 |
Study Chair: | Sunil Sharma, MD | Memorial Sloan-Kettering Cancer Center |
Study ID Numbers: | CDR0000067605, MSKCC-99041, NCI-G00-1683 |
Study First Received: | March 7, 2000 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00004922 |
Health Authority: | United States: Federal Government |
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 |
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 Carcinoma, squamous cell Neoplasm Metastasis Neuroepithelioma Neoplasms, Squamous Cell Adenocarcinoma Carcinoma, Squamous Cell Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Pharmacologic Actions Neoplasms |
Neoplastic Processes Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasms, Basal Cell Antineoplastic Agents, Phytogenic |