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| Sponsor: | H. Lee Moffitt Cancer Center and Research Institute |
|---|---|
| Collaborator: |
Pfizer |
| Information provided by: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT00434109 |
Purpose
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 Procedure: Hepatic Artery Embolizations |
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 |
| Estimated Study Completion Date: | December 2010 |
| Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 1: Experimental |
Drug: Sunitinib malate
Sunitinib malate (Sutent) at a dose of 50mg will be administered orally once daily on days 1-28 of a 42 day cycle. Sutent treatment will be continued until disease progression, or excessive toxicity (as determined by treating physician or primary investigator), or until a maximum of eight cycles, whichever duration is shorter.
Procedure: Hepatic Artery Embolizations
1-3 selective hepatic artery embolizations will be performed at approximately 5-week intervals, based on the extent of hepatic involvement with tumor. Treatment with Sutent will begin no sooner than 7 days after the first hepatic artery embolization. Subsequent embolizations (if necessary) will be scheduled during scheduled Sutent treatment breaks.
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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.
Eligibility| 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:
Contacts and Locations| Contact: Tiffany Campos | 813-745-8358 | tiffany.campos@moffitt.org |
| 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 |
More Information
| Responsible Party: | H. Lee Moffitt Cancer Center & Research Institute ( Jonathan R. Strosberg, M.D. ) |
| Study ID Numbers: | MCC-14888, 105001a, GA6181079 |
| Study First Received: | February 9, 2007 |
| Last Updated: | July 30, 2009 |
| ClinicalTrials.gov Identifier: | NCT00434109 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Carcinoid Pancreatic Metastatic Neuroendocrine Tumors Hepatic Artery Embolization |
Angiogenesis Sunitinib Malate Sutent Tyrosine Kinase Inhibitor |
|
Antineoplastic Agents Pancreatic Neoplasms Neoplasms, Nerve Tissue Physiological Effects of Drugs Neoplasms by Site Sunitinib Neoplasms, Germ Cell and Embryonal Therapeutic Uses Angiogenesis Modulating Agents Growth Inhibitors Endocrine Gland Neoplasms Digestive System Neoplasms Neoplasms by Histologic Type |
Growth Substances Endocrine System Diseases Adenoma, Islet Cell Angiogenesis Inhibitors Pharmacologic Actions Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms Digestive System Diseases Pancreatic Diseases Adenoma Neoplasms, Glandular and Epithelial |