Activity of Sorafenib in Salivary Gland Cancer

• Status: Completed
• Trial end date: 2013-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a single agent, prospective, open-label, monocenter, phase II trial of sorafenib in patients with recurrent and/or metastatic salivary gland carcinoma. This trial will be conducted with the primary aim to determine the response rate (CR+PR) according to the RECIST criteria. Response rate according to CHOI criteria, correlation between CHOI criteria and outcome, disease Control Rate (DCR) and acute toxicity will be evaluated as secondary objectives.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
• Treatments: Sorafenib

Criteria

Inclusion Criteria:

• Histologically proven relapsed and/or metastatic salivary gland cancer for which potentially curative options such as surgery or radiotherapy are not indicated

• One target lesion measurable by CT-scan or MRI according to RECIST criteria

• Age + 18 years

• ECOG 0 or 1

• Adequate bone marrow, liver and renal function

• Signed written informed consent

Exclusion Criteria:

• Symptomatic metastatic brain or meningeal tumors

• History of cardiac disease such as congestive heart failure>NYHA class 2

• Active CAD

• Cardiac arrhythmias requiring anti-arrhythmic therapy or uncontrolled hypertension

• Pregnant or breast-feeding patient

• Patients with evidence or history of bleeding diathesis

• Patients undergoing renal dialysis

• Patients unable to swallow oral medication