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Efficacy Study of Sorafenib and Cyclophosphamide to Treat Neuroendocrine Tumors

Basic Trial Information
Trial Description
Summary
Eligibility Criteria
Trial Contact Information

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II

Treatment

Active

18 and over

Other

SOR-NET-001
NCT00605566

Trial Description

Summary

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.

Eligibility Criteria

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

Trial Contact Information

Trial Lead Organizations/Sponsors

Toronto Western Hospital

Lillian L. Siu

Principal Investigator

Lillian Siu		Ph: 416-946-2911
		Email: lillian.siu@uhn.on.ca

Trial Sites

Canada

Ontario

Toronto

Princess Margaret Hospital

Lillian L. Siu Principal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00605566
Information obtained from ClinicalTrials.gov on July 16, 2008

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.