Phase I Study to Determine MTD of Docetaxel and Cisplatin with Concurrent Radiation Therapy for Stage III Non-Small Cell Lung Cancer.

Objective: To evaluate the maximum tolerated dose (MTD) of docetaxel (DCT) and cisplatin (DDP) concurrently with three dimensional (3D) conformal radiotherapy or IMRT for patients with locally advanced non-small cell lung cancer (stage IIIa and IIIb) after 2-4 cycles of induction chemotherapy.

Methods: Fourteen patients with histological/cytological proven stage III non-small-cell lung cancer were eligible. 3D or IMRT radiotherapy (60-70Gy in 30-35 fractions, 6-7weeks, 2 Gy/fraction) was delivered concurrently with cisplatin and docetaxel, 2 cycles during concurrent chemoradiotherapy (CCRT). The level I dosage was composed of 56 mg/m(2) DCT, on day 1 and 28mg/m(2) DDP, on day 1 and day 2. The level II was composed of 60 mg/m(2) DCT, on day 1 and 30 mg/ m(2) DDP, on day 1 and day 2. The level III was composed of 64 mg/m(2) DCT, on day 1 and 32 mg/ m(2) DDP, on day 1 and day 2.

Results: Fourteen patients were allocated and finished concurrent chemoradiotherapy. The dose-limiting neutropenia was at the dose Level III (64 mg/m(2)) and occurred in 2 of 5 patients. No dose limiting non-hematologic or hematologic toxicity occurred in the other patients.

Conclusions: Patients with locally advanced non-small cell lung cancer may tolerate 60mg/m(2) docetaxel and 60mg/m(2) cisplatin for 2 cycles during concurrent radiotherapy after 2-3 cycles of induction chemotherapy.