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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
Author(s) -
Strieth Sebastian,
Dunau Christoph,
Michaelis Uwe,
Jäger Lorenz,
Gellrich Donata,
Wollenberg Barbara,
Dellian Marc
Publication year - 2014
Publication title -
head and neck
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.012
H-Index - 127
eISSN - 1097-0347
pISSN - 1043-3074
DOI - 10.1002/hed.23397
Subject(s) - medicine , common terminology criteria for adverse events , adverse effect , oncology , chills , paclitaxel , cancer , head and neck squamous cell carcinoma , head and neck cancer , clinical trial , radiation therapy , refractory (planetary science) , surgery , physics , astrobiology
Background 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). Methods 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. Results 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. Conclusion 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. Head Neck 36: 976–984, 2014