Phase I/II clinical study on safety and antivascular effects of paclitaxel encapsulated in cationic liposomes for targeted therapy in advanced head and neck cancer. Issue 7 (11th December 2013)

• Record Type: Journal Article
• Authors: Strieth, Sebastian; Dunau, Christoph; Michaelis, Uwe; Jäger, Lorenz; Gellrich, Donata; Wollenberg, Barbara; Dellian, Marc
• Is Part Of: Head & neck. Volume 36:Issue 7(2014:Jul.)
• Page Start: 976
• Page End: 984
• Publication Date: 2013-12-11
• Subjects: Head -- Diseases -- Periodicals; Neck -- Diseases -- Periodicals; Head -- Periodicals; Neck -- Periodicals; Face -- Periodicals; 617.51059
• DOI: 10.1002/hed.23397
• Languages: English
• ISSNs: 1043-3074

Abstract

<abstract abstract-type="main"> <title>Abstract</title> <sec id="hed23397-sec-0001" sec-type="section"> <title>Background</title> <p>The purpose of this phase I/II clinical trial was to test safety and effectiveness of 2 doses of vascular targeting cationic liposomes encapsulating paclitaxel (EndoTAG‐1 [ET]) in human head and neck squamous cell carcinoma (HNSCC).</p> </sec> <sec id="hed23397-sec-0002" sec-type="section"> <title>Methods</title> <p>Patients with nonresectable therapy‐refractory HNSCC were recruited for both ET treatment groups (3 or 4 patients per group). In cutaneous metastases, laser Doppler blood flow measurements were conducted during infusions.</p> </sec> <sec id="hed23397-sec-0003" sec-type="section"> <title>Results</title> <p>Only adverse events of grade 1 or 2 according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI‐CTCAE version 3.0) – in particular fatigue, chills, and hypertension – occurred. Follow‐up tumor volume measurements revealed stable disease in 4 of 5 cases. Reproducible dose‐dependent blood flow reductions in skin metastases during ET infusions provide evidence of biological effectiveness.</p> </sec> <sec id="hed23397-sec-0004" sec-type="section"> <title>Conclusion</title> <p>Infusions of ET seem to be safe and further phase II and III studies are warranted to prove efficacy in the treatment of HNSCC. © 2013 Wiley Periodicals, Inc. <italic>Head Neck</italic> 36: 976–984, 2014</p> </sec> </abstract>