Clinical Trial: Gemcitabine and Oxaliplatin (GEMOX) in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma

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

Official Title: Gemcitabine and Oxaliplatin in First Line Metastatic or Recurrent Nasopharyngeal Carcinoma (NPC)

Brief Summary:

Primary objective:

To evaluate the response rate of biweekly gemcitabine and oxaliplatin (the GEMOX regimen) in the first line treatment of metastatic or recurrent nasopharyngeal carcinoma.

Secondary objectives:

To assess the toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms in the first line treatment of patients with metastatic or recurrent NPC.


Detailed Summary:
Sponsor: Sanofi

Current Primary Outcome:

  • Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria [ Time Frame: Baseline to end of study ]
  • Safety: Clinical and laboratory criteria [ Time Frame: Baseline to end of study ]
  • The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Baseline to 30 days post treatment ]
  • Occurrence of serious adverse events (SAE) [ Time Frame: Baseline to 30 days post treatment ]
  • Drop-out rate [ Time Frame: End of study ]


Original Primary Outcome:

  • Efficacy: Tumor response rate based on Response Evaluation Criteria in Solid Tumour (RECIST) criteria
  • Safety: Clinical and laboratory criteria
  • The incidence of adverse events based on National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0
  • Occurrence of serious adverse events (SAE)
  • Drop-out rate


Current Secondary Outcome: Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms. [ Time Frame: Baseline to end of study ]

Original Secondary Outcome: Toxicity, duration of response, time to progression, progression-free survival, overall survival and cancer-related symptoms.

Information By: Sanofi

Dates:
Date Received: February 16, 2007
Date Started: March 2005
Date Completion:
Last Updated: September 17, 2009
Last Verified: August 2009