Abstract
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/m 2 × 5 days) in non-small cell lung cancer (NSCLC) patients. CPT-11 was administered by bolus infusion at a starting dose of 100 mg/m 2 on day 1, followed by serial increments at 20 mg/m 2, 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/m 2/day (5-day continuous infusion) for cisplatin and 160 mg/m 2 (day 1) for CPT-11 with rG-CSF support in NSCLC.
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