Clinical Trial: Erlotinib Plus Pemetrexed to Treat Lung Adenocarcinoma With Brain Metastases

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

Official Title: Phase 2 Study of Erlotinib Plus Pemetrexed/Cisplatin Treating Lung Adenocarcinoma With Brain Metastases

Brief Summary: The purpose of this study is to determine whether erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.

Detailed Summary: Non-small lung cancer (NSCLC) is the leading cause of death in the world. Brain metastases are a frequent complication of NSCLC, especially in lung adenocarcinoma. 30-50% or more these patients will develop brain metastases at first time or during the treatment. Limited treatment options, whole brain radiotherapy (WBRT) combined with or without stereotactic radiosurgery (SRS) as the primary treatment approach, are available for brain metastases patients with poor survival. So the availability of effective therapies are therefore of great importance. Currently, two agents (erlotinib and pemetrexed) are reported more effective in lung adenocarcinoma patients with brain metastases. The heterogeneity of NSCLC tumors provides a strong rationale for using combination therapy with targeted agents that have different mechanisms of action, moreover different combination offering synergistic effects. So we investigate if erlotinib plus pemetrexed, cisplatin are effective and safe in treating lung adenocarcinoma with brain metastases.
Sponsor: Guangzhou Medical University

Current Primary Outcome: The objective response rate of brain metastases [ Time Frame: Patients will be followed for an expected average of 6 weeks ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • The disease control response rate of disease [ Time Frame: Patients will be followed for an expected average of 6 weeks ]
  • Progression-free survival of patients [ Time Frame: 2 years after first treatment ]
  • Number of participants with adverse events as a measure of safety [ Time Frame: 2 years after first treatment ]
  • Overall survival of patients [ Time Frame: 3 years after the first treatment ]


Original Secondary Outcome:

  • The disease control response rate of disease [ Time Frame: Patients will be followed for an expected average of 6 weeks ]
  • Progression-free survival of patients [ Time Frame: 2 years after first treatment ]
  • Number of participants with adverse events as a measure of safety [ Time Frame: 2 years after first treatment ]
  • Qualities on the Function Assess Cancer Treatment-Lung (FACT-L) [ Time Frame: 2 years after first treatment ]


Information By: Guangzhou Medical University

Dates:
Date Received: April 11, 2012
Date Started: January 2012
Date Completion:
Last Updated: January 23, 2015
Last Verified: January 2015