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Sponsors and Collaborators: |
H. Lee Moffitt Cancer Center and Research Institute Pfizer |
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Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
ClinicalTrials.gov Identifier: | NCT00434109 |
This is a Phase II study consisting of 1-3 selective hepatic artery embolizations at approximately 5-week intervals, based on the extent of hepatic involvement with the tumor. Sunitinib malate (Sutent) will be administered on days 1-28 of a 42 day cycle. We believe that Sutent following embolization will significantly improve the duration of your response to treatment. Sutent treatment will be continued until disease progression, or excessive toxicity, or a maximum of eight cycles, whichever duration is shorter.
Condition | Intervention | Phase |
---|---|---|
Neuroendocrine Tumor Islet Cell Tumor |
Drug: Sunitinib malate, Sutent |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Phase II Study of Sunitinib Malate Following Hepatic Artery Embolization for Metastatic Gastrointestinal Neuroendocrine Tumors |
Estimated Enrollment: | 39 |
Study Start Date: | November 2006 |
This is a single-center, open-label, non-randomized, prospective phase II trial. The treatment will consist of 1-3 selective hepatic artery embolizations at approximately 5-week intervals, based upon the extent of hepatic involvement with the tumor. Sunitinib malate (Sutent) will be administered daily on days 1-28 of a 42 day cycle. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks.
A visit will be required before the beginning of every 6-week cycle for physical examination (including blood work) and toxicity assessment. A CT or MRI scan of the abdomen (as well as any other relevant body part with metastases) will be obtained prior to the second cycle and every other cycle there after (prior to cycle 2, 4, 6 and 8).
Sutent treatment will be continued until disease progression, or excessive toxicity, or a maximum of eight cycles, whichever duration is shorter. Patients will undergo one final CT or MRI scan along with a follow-up visit 3 months after initiating the last cycle.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Adequate organ function as defined by the following criteria:
Exclusion Criteria:
Contact: Maritza E Gaines | 813-745-1805 | gainesma@moffitt.usf.edu |
Contact: Tiffany Campos | 813-745-8358 | campostl@moffitt.usf.edu |
United States, Florida | |
H. Lee Moffitt Cancer Center & Research Institute | Recruiting |
Tampa, Florida, United States, 33612 | |
Sub-Investigator: Nancy M. Gardner, PhD, ARNP |
Principal Investigator: | Jonathan Strosberg, MD | H. Lee Moffitt Cancer Center and Research Institute |
Principal Investigator: | Larry K. Kvols, MD | H. Lee Moffitt Cancer Center and Research Institute |
Study ID Numbers: | MCC-14888 |
Study First Received: | February 9, 2007 |
Last Updated: | February 9, 2007 |
ClinicalTrials.gov Identifier: | NCT00434109 |
Health Authority: | United States: Institutional Review Board |
Carcinoid Pancreatic Metastatic Neuroendocrine Tumors Hepatic Artery Embolization |
Angiogenesis Sunitinib Malate Sutent Tyrosine Kinase Inhibitor |
Digestive System Neoplasms Pancreatic Neoplasms Endocrine System Diseases Adenoma, Islet Cell Neuroendocrine Tumors Carcinoid tumor Neuroectodermal Tumors Digestive System Diseases Sunitinib Neoplasms, Germ Cell and Embryonal |
Neuroepithelioma Gastrointestinal Neoplasms Pancreatic Diseases Carcinoid Tumor Endocrinopathy Pancreatic islet cell tumors Adenoma Neoplasms, Glandular and Epithelial Endocrine Gland Neoplasms |
Neoplasms Neoplasms by Site Neoplasms by Histologic Type Antineoplastic Agents Growth Substances Therapeutic Uses |
Physiological Effects of Drugs Neoplasms, Nerve Tissue Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |