Clinical Trial: Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma (NPC) Who Have Had Prior Platinum Based Chemotherapy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Open-Label Single-Arm Phase 2 Study of Alimta in Patients With Recurrent or Metastatic Nasopharyngeal Carcinoma Who Have Had Prior Platinum Based Chemotherapy

Brief Summary: This is a pilot phase II study of locally advanced or metastatic nasopharyngeal carcinoma (NPC) with the single drug Alimta. The objective of this study is to assess efficacy and safety profiles of Alimta as 2nd line treatment for patients with advanced NPC.

Detailed Summary:
Sponsor: Sun Yat-sen University

Current Primary Outcome: response rate [ Time Frame: Jan 2010 ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • progression-free survival [ Time Frame: Jan 2010 ]
  • overall survival [ Time Frame: Jan 2010 ]
  • safety profile of pemetrexed (Alimta) treatment [ Time Frame: Jan 2010 ]
  • pharmacokinetic analysis of half-life, maximum plasma concentration (Cpmax), clearance (CL), area under the curve (AUC), and apparent volume of distribution [ Time Frame: Jan 2010 ]
  • evaluate the relationship between the expression of alpha folate receptor protein, TS and clinical response [ Time Frame: Jan 2010 ]


Original Secondary Outcome: Same as current

Information By: Sun Yat-sen University

Dates:
Date Received: February 25, 2008
Date Started: November 2007
Date Completion:
Last Updated: February 14, 2012
Last Verified: February 2012