ImClone 0452

Principal Investigator:	Peter Kozuch, MD
Time frame of study:	Ongoing
Location of Study:	Beth Israel Medical Center St.Luke's-Roosevelt Hospital Center
Contact:	Continuum Cancer Research Program (212) 844-6286

Summary:
The antibody cetuximab is directed against the epidermal growth factor receptor (EGFR), which is involved in the development and progression of many common tumors including non-small cell lung cancer (NSCLC). A better response rate of cetuximab in addition to chemotherapy compared with chemotherapy alone has been demonstrated.

Cetuximab in combination with the anti-cancer drug docetaxel has shown promising safety and efficacy results in patients that do not respond to initial therapy. The chemotherapy agent pemetrexed has a therapeutic equivalence to docetaxel, thus providing a rationale to investigate the usefulness of cetuximab in combination with docetaxel or pemetrexed for NSCLC patients.

Eligibility and Treatment Plan:
Patients, 18 years and older, with pathologically confirmed, metastatic and/or unresectable, locally advanced NSCLC who have failed or progressed after a platinum-based doublet in first-line therapy and who have a Karnofsky performance status (KPS) of 60% – 100%.

There are four treatment arms: (one cycle of therapy is a 3-week treatment period)
• Arm 1D) up to 6 cycles of cetuximab + docetaxel
• Arm 1P) up to 6 cycles of cetuximab + pemetrexed
• Arm 2D) up to 6 cycles of docetaxel alone
• Arm 2P) up to 6 cycles of pemetrexed alone

Benefits and/or Compensation:
Participants receive study-related medication at no charge under the supervision and care of a team of medical professionals. The information gathered from this study may be beneficial to future patients, and cetuximab may improve progression free and overall survival time for recurrent or progressive NSCLC patients.