A phase I study of irinotecan and infusional cisplatin with recombinant human granulocyte colony-stimulating factor support in the treatment of advanced non-small cell lung cancer.

We conducted a phase I study to examine whether support with recombinant human granulocyte colony-stimulating factor (rG-CSF) would permit dose intensification of irinotecan (CPT-11) in combination with cisplatin (20 mg/m2 x 5 days) in non-small cell lung cancer (NSCLC) patients. CPT-11 was administered by bolus infusion at a starting dose of 100 mg/m2 on day 1, followed by serial increments at 20 mg/m2, given every 4 weeks. The major toxic effects were granulocytopenia and diarrhoea. The response rate was 55% (11/20). The optimum dose for phase II studies appears to be 20 mg/m2/day (5-day continuous infusion) for cisplatin and 160 mg/m2 (day 1) for CPT-11 with rG-CSF support in NSCLC.