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Sponsors and Collaborators: |
Mayo Clinic National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00075439 |
RATIONALE: Gefitinib may stop the growth of tumor cells by blocking the enzymes necessary for their growth.
PURPOSE: This phase II trial is studying how well gefitinib works in treating patients with progressive metastatic neuroendocrine tumors.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Neoplastic Syndrome |
Drug: gefitinib |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial Of ZD1839 (Iressa) In Metastatic Neuroendocrine Tumors |
Study Start Date: | December 2003 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to disease type (carcinoid vs islet cell and other neuroendocrine tumors).
Patients receive oral gefitinib once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.
PROJECTED ACCRUAL: A total of 34-90 patients (22-51 for carcinoid stratum and 12-39 for islet cell/other neuroendocrine tumor stratum) will be accrued for this study within 9 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed metastatic neuroendocrine neoplasm OR primary neuroendocrine tumor with clear clinical evidence of metastases
Radiographic evidence of disease progression within the past 60 weeks after prior systemic therapy, chemoembolization, embolization, or observation and defined as 1 of the following:
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Ophthalmic
No known abnormality of the cornea, such as any of the following:
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 1 prior systemic chemotherapy regimen
Endocrine therapy
Radiotherapy
Surgery
Other
More than 7 days since prior administration of the following CYP3A4 inducers:
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259 | |
United States, District of Columbia | |
Howard University Cancer Center at Howard University Hospital | |
Washington, District of Columbia, United States, 20060 | |
United States, Florida | |
Mayo Clinic - Jacksonville | |
Jacksonville, Florida, United States, 32224 | |
United States, Maryland | |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | |
Baltimore, Maryland, United States, 21231-2410 | |
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | |
Detroit, Michigan, United States, 48201-1379 | |
United States, Minnesota | |
Mayo Clinic Cancer Center | |
Rochester, Minnesota, United States, 55905 | |
United States, Missouri | |
Siteman Cancer Center at Barnes-Jewish Hospital | |
Saint Louis, Missouri, United States, 63110 | |
United States, Wisconsin | |
University of Wisconsin Comprehensive Cancer Center | |
Madison, Wisconsin, United States, 53792 |
Study Chair: | Timothy Hobday, MD | Mayo Clinic |
Study ID Numbers: | CDR0000346420, MAYO-MC0279, NCI-6113 |
Study First Received: | January 9, 2004 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00075439 |
Health Authority: | United States: Federal Government |
metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor gastrinoma insulinoma WDHA syndrome |
somatostatinoma pancreatic polypeptide tumor glucagonoma recurrent islet cell carcinoma |
Gastrointestinal Diseases Pancreatic Neoplasms Pancreatic Polypeptide Neoplasms, Germ Cell and Embryonal Neuroepithelioma Gefitinib Endocrine Gland Neoplasms Digestive System Neoplasms Carcinoma, Islet Cell Serotonin Syndrome Insulinoma Endocrine System Diseases Adenoma, Islet Cell Malignant Carcinoid Syndrome Carcinoid syndrome |
Recurrence Neuroendocrine Tumors Carcinoma Carcinoid tumor Neuroectodermal Tumors Gastrinoma Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Endocrinopathy Adenocarcinoma Adenoma Pancreatic islet cell tumors Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Disease Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Enzyme Inhibitors Protein Kinase Inhibitors |
Pharmacologic Actions Neoplasms Pathologic Processes Neoplasms by Site Syndrome Therapeutic Uses |