Clinical Trial: Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

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

Official Title: A Phase I/II Trial of Cetuximab in Patients With Lung Adenocarcinoma Receiving Erlotinib That Have Developed "Acquired Resistance" to Erlotinib

Brief Summary:

The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of the phase I portion of this trial is to find out the highest dose of cetuximab that can be taken together with erlotinib. This study will also give an idea of how well cetuximab shrinks lung cancer when given with erlotinib.

The purpose of this study is to test if cetuximab (Erbitux) can shrink lung cancers that initially became smaller after taking erlotinib or gefitinib and then started to get bigger despite continuing treatment. Cetuximab is a medicine approved by the U.S. Food and Drug administration for treatment of head and neck and colon cancer. The goal of this phase is to determine if cetuximab given with erlotinib causes lung cancers to shrink in size.


Detailed Summary:
Sponsor: Memorial Sloan Kettering Cancer Center

Current Primary Outcome: The Maximum Tolerated Dose (MTD) of Cetuximab Given Every 2 Weeks [ Time Frame: At conclusion of study, up to 24 weeks ]

To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion)


Original Primary Outcome:

  • To determine the maximum tolerated dose (MTD) of cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (phase I portion) [ Time Frame: conclusion of study ]
  • To determine the overall response rate (CR+PR) of cetuximab in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib. This is for the phase II portion. [ Time Frame: conclusion of study ]


Current Secondary Outcome:

Original Secondary Outcome:

  • To determine the progression-free survival, and overall survival after treatment with cetuximab given every 2 weeks in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (ph II) [ Time Frame: conclusion of study ]
  • To determine the toxicity profile of cetuximab and erlotinib in patients with lung adenocarcinoma receiving erlotinib that have developed acquired resistance to erlotinib (ph II). [ Time Frame: conclusion of study ]


Information By: Memorial Sloan Kettering Cancer Center

Dates:
Date Received: July 15, 2008
Date Started: July 2008
Date Completion:
Last Updated: April 13, 2015
Last Verified: April 2015