Randomized Phase II Study of Cetuximab in Combination With Gemcitabine or Gemcitabine Followed by Cetuximab in Advanced Non Small-cell Lung Cancer Patients Who Are Not Candidates for Platinum Based Therapy.
The standard treatment for advanced non small cell lung cancer (NSCLC) is combination
chemotherapy with cisplatin or carboplatin. Due to its toxicity, this therapy may not be
suited for certain patients including the elderly, those whose general condition is poor.
Combining chemotherapy with a biologic agent ("targeted therapy") is a new strategy being
evaluated for the treatment of NSCLC, and cetuximab is one of the drugs that has shown
promise for its activity and tolerability. This study aims to determine the more promising
of 2 methods of combining gemcitabine with cetuximab (in combination vs. sequential
administration), in two groups of patients who are not candidates for combination platinum
based chemotherapy: patients under age 70 with performance status 2 (expected enrollment 42)
, and patients over age 70 (expected enrollment 58).
Patients will be randomly assigned to one of two treatment arms:
- Arm A: Cetuximab + Gemcitabine:
- Cetuximab given intravenously weekly AND
- Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of each
3 week cycle)
- Arm B: Gemcitabine followed by Cetuximab:
- Gemcitabine given intravenously for a maximum of 6 cycles (on days 1 and 8 of
each 3 week cycle) THEN
- Cetuximab given intravenously weekly
In Arm B, Cetuximab is administered as maintenance therapy when there has been an objective
response to chemotherapy, or as second line therapy in patients who had disease progression
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
one year survival rate
Cesare Gridelli, M.D.
S.G. Moscati Hopital, Avellino, Italy, Division of Medical Oncology
Italy: Ethics Committee