Gemcitabine, Docetaxel, and Cetuximab in Patients With Unresectable Advanced Non-Small Cell Lung Cancer

• Progression Free Survival (PFS) [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  Progression free survival was defined as the interval between the start date of treatment and the date of occurrence of progressive disase or death from any cause.
• Response Duration [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  The Response Duration was calculated from time of initial measured response to date of first observation of progressive disease.

• Progression free survival
• Toxicity of drug combination

This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

Upon determination of eligibility all patients will receive:

• Docetaxel + Gemcitabine + Cetuximab

• Drug: Gemcitabine
  1000mg/m2 30min IV, Day 1 & 8
  Other Name: Gemzar
• Drug: Docetaxel
  30mg/m2, 30min IV, day 1 & 8
  Other Name: Taxotere
• Drug: Cetuximab
  100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 & 15, all subsequent cycles 250mg/m2 IV day 1, 8, & 15
  Other Name: Erbitux

Inclusion Criteria:

To be included in the study, you must meet the following criteria:

• 18 years of age or older
• Non-small cell lung cancer confirmed by biopsy
• Unresectable stage III or IV disease
• Measurable disease
• Must not have received any prior chemotherapy for lung cancer
• Able to perform activities of daily living without considerable assistance
• Adequate bone marrow, kidney, and liver function
• Signed informed consent

Exclusion Criteria:

You cannot participate in the study if any of the following apply to you:

• History of serious heart disease within six months prior to study entry
• Prior treatment with agents that target the EGFR pathway
• History of any other uncontrolled or significant disease

Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have. You can then decide if you wish to participate.