| January 18, 2008 |
| February 12, 2009 |
| January 2008 |
| December 2009 (final data collection date for primary outcome measure) |
| To determine the efficacy of combination sorafenib plus metronomic cyclophosphamide in advanced, progressive NET, as measured by the objective response rate (ORR), and to assess the feasibility of the individual dose adjustment of sorafenib. [ Time Frame: Every 8 weeks ] [ Designated as safety issue: No ] |
| To determine the efficacy of combination sorafenib plus metronomic cyclophosphamide in advanced, progressive NET, as measured by the objective response rate (ORR), and to assess the feasibility of the individual dose adjustment of sorafenib. [ Time Frame: Every 12 weeks ] [ Designated as safety issue: No ] |
| Complete list of historical versions of study NCT00605566 on ClinicalTrials.gov Archive Site |
| To assess the toxicity, time-to-progression (TTP), overall survival (OS), and 1 year survival rate. [ Time Frame: One year ] [ Designated as safety issue: Yes ] |
| Same as current |
| |
| Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors |
| Tailored-Dose Sorafenib Plus Metronomic Cyclophosphamide in Advanced Neuroendocrine Tumors (NET): a Phase II Clinical Trial Based on Individual Pharmacodynamic Assessment |
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. |
| |
| Phase II |
| Interventional |
| Supportive Care, Open Label, Single Group Assignment, Efficacy Study |
| Neuroendocrine Tumors |
| Drug: sorafenib and cyclophosphamide |
| Experimental: Patients will receive sorafenib and cyclophosphamide. |
| |
| |
| Recruiting |
| 41 |
|
| December 2009 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Histologically or cytologically confirmed neuroendocrine tumors
- Progressive and measurable metastatic disease
- Patients must not have disease that is currently amenable to surgery
- Life expectancy of greater than 3 months
- ECOG performance status ≤2
- Patients must have normal organ and marrow function
- Negative pregnancy test; agreement to use adequate birth control
Exclusion Criteria:
- Patients receiving chemotherapy or radiotherapy within last 4 weeks
- Patients that had received Sorafenib for advanced NET(neuroendocrine tumors) are not allowed
- Any other investigational agents within 4 weeks of study
- Patients with known brain metastases
- History of allergic reactions to compounds of similar chemical/biologic composition to sorafenib or cyclophosphamide
- Concurrent cancer from another primary site requiring treatment within the past 3 years
- Uncontrolled intercurrent illness
- Pregnant women and women who are breastfeeding
- HIV-positive patients receiving combination anti-retroviral therapy
|
| Both |
| 18 Years and older |
| No |
|
|
| Canada |
| |
| NCT00605566 |
| Dr. Lillian Siu, Drug Development Program, Princess Margaret Hospital |
| SOR-NET-001 |
| University Health Network, Toronto |
|
| Principal Investigator: |
Lillian Siu, MD |
University Health Network, Toronto |
|
|
| University Health Network, Toronto |
| February 2009 |
