title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  Infusions of ET seem to be safe and further phase II and III studies are warranted to prove efficacy in the treatment of HNSCC.
authors.affiliation: Department of Otorhinolaryngology, Goethe-University, Frankfurt/M., Germany.
authors.forename: Sebastian
authors.initials: S
authors.lastname: Strieth
authors.forename: Christoph
authors.initials: C
authors.lastname: Dunau
authors.forename: Uwe
authors.initials: U
authors.lastname: Michaelis
authors.forename: Lorenz
authors.initials: L
authors.lastname: Jäger
authors.forename: Donata
authors.initials: D
authors.lastname: Gellrich
authors.forename: Barbara
authors.initials: B
authors.lastname: Wollenberg
authors.forename: Marc
authors.initials: M
authors.lastname: Dellian
mesh_terms: D000368:Aged; D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D002294:Carcinoma, Squamous Cell / Q000098:blood supply / Q000188:drug therapy* / Q000473:pathology; D016503:Drug Delivery Systems; D005260:Female; D005338:Fibrin Fibrinogen Degradation Products / Q000032:analysis; D006258:Head and Neck Neoplasms / Q000098:blood supply / Q000188:drug therapy* / Q000473:pathology; D006801:Humans; D007262:Infusions, Intravenous; D017078:Laser-Doppler Flowmetry; D007958:Leukocyte Count; D008081:Liposomes; D008297:Male; D008875:Middle Aged; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects; D010976:Platelet Count; D011446:Prospective Studies; D012867:Skin / Q000098:blood supply; D014409:Tumor Necrosis Factor-alpha / Q000097:blood
chemical_list: D020533:Angiogenesis Inhibitors; D005338:Fibrin Fibrinogen Degradation Products; D008081:Liposomes; D014409:Tumor Necrosis Factor-alpha; C036309:fibrin fragment D; D017239:Paclitaxel
keywords: EndoTAG-1; HNSCC; Lipopac; laser Doppler blood flowmetry; vascular disrupting agent