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Sponsored by: |
University Health Network, Toronto |
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Information provided by: | University Health Network, Toronto |
ClinicalTrials.gov Identifier: | NCT00605566 |
This is a phase II clinical trial to assess the efficacy of the combination of metronomic cyclophosphamide and tailored sorafenib dosing in advanced, progressive NET. NET are highly vascular tumors, and high VEGF expression has been correlated with worse clinical and pathological characteristics as well as poor prognosis. A novel antiangiogenic approach relies on targeting not only the endothelial cells but also rendering them more sensitive to VEGFR blockade by achieving pericyte detachment. In this study, the dose of sorafenib will be titrated up to a maximum of 800mg BID based on patients' toxicity and on a novel pharmacodynamic assay that measures inhibition of molecular target(PDGFR) in patients' peripheral blood mononuclear cells. Dual VEGFR targeting is achieved by administering sorafenib plus metronomic low dose cyclophosphamide.
Condition | Intervention | Phase |
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Neuroendocrine Tumors |
Drug: sorafenib and cyclophosphamide |
Phase II |
Study Type: | Interventional |
Study Design: | Supportive Care, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Tailored-Dose Sorafenib Plus Metronomic Cyclophosphamide in Advanced Neuroendocrine Tumors (NET): a Phase II Clinical Trial Based on Individual Pharmacodynamic Assessment |
Estimated Enrollment: | 41 |
Study Start Date: | January 2008 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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I: Experimental
Patients will receive sorafenib and cyclophosphamide.
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Drug: sorafenib and cyclophosphamide
During a run-in period, patient will start taking 50 mg QD of oral cyclophosphamide and 200 mg BID of sorafenib. On day 8 of run-in the patient will be evaluated for toxicity. In the absence of toxicity, the patient will be escalated to sorafenib 400 mg BID and continue on daily 50 mg of cyclophosphamide, or the patient will be informed to continue on sorafenib 200 mg BID and cyclophosphamide 50 mg QD. Dose escalation procedure will be repeated every 2 weeks until unable to tolerate the study drug, or a maximum of 800 mg BID is reached, or achievement of > 90% inhibition of phosphorylation of PDGFR/Raf axis in PBMC. After "run-in" period, patient begins cycle 1, each cycle will last 28 days. Both cyclophosphamide and sorafenib will be taken orally.
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Lillian Siu | 416-946-2911 | lillian.siu@uhn.on.ca |
Canada, Ontario | |
Princess Margaret Hospital | Recruiting |
Toronto, Ontario, Canada, M5G 2M9 | |
Principal Investigator: Lillian Siu |
Principal Investigator: | Lillian Siu, MD | University Health Network, Toronto |
Responsible Party: | Drug Development Program, Princess Margaret Hospital ( Dr. Lillian Siu ) |
Study ID Numbers: | SOR-NET-001 |
Study First Received: | January 18, 2008 |
Last Updated: | January 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00605566 |
Health Authority: | Canada: Ethics Review Committee; Canada: Health Canada |
Neuroendocrine sorafenib cyclophosphamide pharmacodynamic |
Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Cyclophosphamide Sorafenib Neuroendocrine Tumors |
Neoplasms by Histologic Type Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Neoplasms, Nerve Tissue Physiological Effects of Drugs Enzyme Inhibitors Protein Kinase Inhibitors |
Immunosuppressive Agents Pharmacologic Actions Neoplasms Therapeutic Uses Myeloablative Agonists Antineoplastic Agents, Alkylating Antirheumatic Agents Alkylating Agents |