Phase II Study of Chemotherapy With Gemcitabine in Prolonged Infusion or With Schedules With Cisplatin in Non-small Cell Lung Cancer Elderly Patients
The study design includes three parallel phase II studies, all with the same rules for
patient selection and outcome assessment. In the two studies of cisplatin-based doublets, a
dose-finding phase is planned, with subsequent cohorts of 6 patients treated with increasing
doses of cisplatin (50-60-70 mg/m²). Following this phase, patients will be assigned to the
three studies through a randomization procedure, to reduce selection biases.
Arm A: gemcitabine:
Gemcitabine 1200 mg/m2 intravenously in 2 hours (10 mg/m²/minute) on days 1 & 8 of each
cycle, every 21 days, for a maximum of 6 cycles.
Arm B: cisplatin + vinorelbine:
Vinorelbine 25 mg/m² on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day 1 of
each cycle, every 21 days, for a maximum of 6 cycles.
Arm C: cisplatin + gemcitabine:
Gemcitabine 1000 mg/m2,, on days 1 & 8, followed by Cisplatin (50 or 60 or 70 mg/m²) on day
1 of each cycle, every 21 days, for a maximum of 6 cycles.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Activity and toxicity of monochemotherapy with gemcitabine as prolonged infusion
Cesare Gridelli, M.D.
San Giuseppe Moscati Hospital
Italy: Ethics Committee