title: Phase I dose-escalation study of aflibercept plus docetaxel in nasopharyngeal carcinoma and other solid tumors.
abstract: OBJECTIVE
  To confirm whether the aflibercept dose, plus docetaxel, in western study TCD6120 is appropriate for Chinese patients with nasopharyngeal carcinoma (NPC) and other solid tumors.
  
  
  METHODS
  To assess dose-limiting toxicity of every 3-week 4 mg/kg or 6 mg/kg aflibercept plus 75 mg/m(2) docetaxel.
  
  
  RESULTS
  Previously treated patients (16 with NPC and 4 with lung cancer) were enrolled. At 6 mg/kg aflibercept: one dose-limiting toxicity was seen (neutropenic infection); the most frequently reported all-grade adverse events were oropharyngeal pain, stomatitis and alopecia; the most frequently reported grade 3/4 adverse events were oropharyngeal pain, stomatitis and neutropenic infection. Eleven patients had partial response and 3 had stable disease.
  
  
  CONCLUSIONS
  Preliminary efficacy data for docetaxel/aflibercept are encouraging in Chinese patients with NPC.
  
  
  BACKGROUND
  This study was registered with the University Hospital Medical Information Network Clinical Trials Registry ( ClinicalTrials.gov , NCT01148615).
authors.affiliation: The State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, People's Republic of China.
authors.forename: Yan
authors.initials: Y
authors.lastname: Huang
authors.forename: Ben-Yan
authors.initials: BY
authors.lastname: Zou
authors.forename: Li-Ping
authors.initials: LP
authors.lastname: Zhao
authors.forename: Hong-Yun
authors.initials: HY
authors.lastname: Zhao
authors.forename: Yuan-Yuan
authors.initials: YY
authors.lastname: Zhao
authors.forename: Cong
authors.initials: C
authors.lastname: Xue
authors.forename: Jian-Wei
authors.initials: JW
authors.lastname: Zhang
authors.forename: Fei
authors.initials: F
authors.lastname: Xu
authors.forename: Li-Kun
authors.initials: LK
authors.lastname: Chen
authors.forename: Jun-Ling
authors.initials: JL
authors.lastname: Liu
authors.forename: Zhi-Huang
authors.initials: ZH
authors.lastname: Hu
authors.forename: Xuan
authors.initials: X
authors.lastname: Wu
authors.forename: Jing
authors.initials: J
authors.lastname: Zhang
authors.forename: Yu-Xiang
authors.initials: YX
authors.lastname: Ma
authors.forename: Chen-Lu
authors.initials: CL
authors.lastname: Wei
authors.forename: Ying
authors.initials: Y
authors.lastname: Ma
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage; D044466:Asian People; D002277:Carcinoma; D000077143:Docetaxel; D064420:Drug-Related Side Effects and Adverse Reactions / Q000473:pathology*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D000077274:Nasopharyngeal Carcinoma; D009303:Nasopharyngeal Neoplasms / Q000000981:diagnostic imaging / Q000188:drug therapy* / Q000473:pathology; D009362:Neoplasm Metastasis; D011859:Radiography; D040262:Receptors, Vascular Endothelial Growth Factor / Q000008:administration & dosage* / Q000009:adverse effects; D011993:Recombinant Fusion Proteins / Q000008:administration & dosage* / Q000009:adverse effects; D043823:Taxoids / Q000008:administration & dosage* / Q000009:adverse effects; D042461:Vascular Endothelial Growth Factor A / Q000037:antagonists & inhibitors / Q000378:metabolism
chemical_list: D011993:Recombinant Fusion Proteins; D043823:Taxoids; C467484:VEGFA protein, human; D042461:Vascular Endothelial Growth Factor A; C533178:aflibercept; D000077143:Docetaxel; D040262:Receptors, Vascular Endothelial Growth Factor
keywords: Phase I; aflibercept; docetaxel; nasopharyngeal carcinoma; pharmacokinetics