The primary end-points of the GECO study~To evaluate the tolerability of three innovative schedules of treatment for advanced NSCLC~To evaluate the efficacy of the addition of rofecoxib to first-line chemotherapy in the treatment of patients affected by advanced NSCLC~To evaluate the efficacy of prolonged continuous infusion (p.c.i.) of gemcitabine, with the fixed infusion rate of 10 mg/sqm/minute) versus the standard administration in 30 minutes, in combination with cisplatin, in the treatment of patients affected by advanced NSCLC~Four treatment arms are planned.~ARM A standard treatment : cisplatin + gemcitabine~ARM B cisplatin + gemcitabine + rofecoxib~ARM C cisplatin + p.c.i. gemcitabine (10 mg/sqm/minute)~ARM D cisplatin + p.c.i gemcitabine (10 mg/sqm/minute) + rofecoxib~The phase II part of the study for experimental arms B, C and D will be conducted to evaluate tolerability in the three treatment arms.~The phase III study for efficacy has been designed according to a factorial 2x2 model with the planned comparison of~The efficacy of rofecoxib: A + C (arms without rofecoxib) vs B+D (arms with rofecoxib)~The efficacy of p.c.i. gemcitabine: A + B (arms with standard infusion of gemcitabine) vs C+ D (arms with p.c.i gemcitabine)
The purpose of this study is to evaluate the tolerability and efficacy of the addition of rofecoxib to first-line chemotherapy, and to evaluate the efficacy of prolonged continuous infusion of gemcitabine in combination with cisplatin in the treatment of patients affected by advanced non-small cell lung cancer.