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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: | NCT00131911 |
RATIONALE: Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying how well sorafenib works in treating patients with progressive metastatic neuroendocrine tumors.
Condition | Intervention | Phase |
---|---|---|
Gastrointestinal Carcinoid Tumor Islet Cell Tumor Neoplastic Syndrome |
Drug: sorafenib tosylate |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Trial of Bay 43-9006 in Progressive Metastatic Neuroendocrine Tumors |
Estimated Enrollment: | 90 |
Study Start Date: | June 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to tumor type (carcinoid vs islet cell/other well-differentiated tumor).
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed every 3 months until disease progression and then every 6 months for up to 2 years from study entry.
PROJECTED ACCRUAL: Approximately 38-90 patients (22-46 with carcinoid tumors and 12-39 with islet cell carcinoma/other well-differentiated tumors) will be accrued for this study within 3.2-7.5 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed neuroendocrine tumor
Carcinoid tumor OR islet cell carcinoma/other well-differentiated tumor
PATIENT CHARACTERISTICS:
Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Gastrointestinal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
No more than 1 prior systemic chemotherapy regimen
Endocrine therapy
Radiotherapy
Surgery
Other
No concurrent therapeutic anticoagulation
United States, Arizona | |
Mayo Clinic Scottsdale | |
Scottsdale, Arizona, United States, 85259-5499 | |
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, 53792-3236 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital - Perth | |
Perth, Western Australia, Australia, 6009 | |
Hong Kong | |
Prince of Wales Hospital | |
Shatin, New Territories, Hong Kong | |
Singapore | |
National Cancer Centre - Singapore | |
Singapore, Singapore, 169610 |
Study Chair: | Timothy Hobday, MD | Mayo Clinic |
Study ID Numbers: | CDR0000437792, MAYO-MC044H, NCI-7046 |
Study First Received: | August 16, 2005 |
Last Updated: | July 23, 2008 |
ClinicalTrials.gov Identifier: | NCT00131911 History of Changes |
Health Authority: | United States: Federal Government |
metastatic gastrointestinal carcinoid tumor recurrent gastrointestinal carcinoid tumor gastrinoma insulinoma glucagonoma |
pancreatic polypeptide tumor somatostatinoma recurrent islet cell carcinoma WDHA syndrome |
Gastrointestinal Diseases Pancreatic Neoplasms Pancreatic Polypeptide Protein Kinase Inhibitors Zollinger-Ellison Syndrome Neoplasms, Germ Cell and Embryonal Neuroepithelioma Endocrine Gland Neoplasms Carcinoid Syndrome Pancreatic Islet Cell Tumors Digestive System Neoplasms Carcinoma, Islet Cell Serotonin Syndrome Insulinoma Endocrine System Diseases |
Adenoma, Islet Cell Malignant Carcinoid Syndrome Recurrence Neuroendocrine Tumors Carcinoma Neuroectodermal Tumors Gastrinoma Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Endocrinopathy Adenocarcinoma Sorafenib Adenoma |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Gastrointestinal Diseases Pancreatic Neoplasms Neoplasms, Nerve Tissue Protein Kinase Inhibitors Pathologic Processes Neoplasms by Site Therapeutic Uses Neoplasms, Germ Cell and Embryonal Syndrome Endocrine Gland Neoplasms Neoplasms by Histologic Type Disease Digestive System Neoplasms |
Endocrine System Diseases Enzyme Inhibitors Adenoma, Islet Cell Malignant Carcinoid Syndrome Pharmacologic Actions Carcinoma Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Digestive System Diseases Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Adenocarcinoma Sorafenib |