A PHASE-I STUDY OF PACLITAXEL IN COMBINATION WITH ETOPOSIDE IN PATIENTS WITH STAGE IIIB IV NONSMALL CELL LUNG-CANCER (NSCLC)/

Paclitaxel is a new antineoplastic agent with activity in lung cancer. This phase I clinical trial was designed to determine the maximum tol erated dose (MTD) of paclitaxel in combination with etoposide in previ ously untreated patients with non-small cell lung cancer (NSCLC). Dose s of paclitaxel were in the range of 150-225 mg/m(2) (dl) and of etopo side in the range of 100-120 mg/m(2) (d2-4). The drugs were administer ed by i.v. infusion over 3 h (paclitaxel) and 2 h (etoposide). The pat ients received four courses at 21-day intervals, Twenty-four patients (six female, 18 male) entered the trial. The characteristics of the pa tients were as follows: median age 64 (55-73) years; Karnofsky index 8 0% (70-90%); stage IIIB n = 7, IV n = 17; histology, 14 adenocarcinoma , 10 squamous carcinoma. Hypersensitivity reactions after paclitaxel w ere not observed. The most relevant toxic effect observed was neutrope nia (WHO grade 3-4). Three episodes of febrile neutropenia, two episod es of absolute neutropenia (< 100/mu l for > 3 days), and one case of mucositis (WHO grade greater than or equal to 3 for > 7 days) occurred . It can be concluded that the MTD of paclitaxel in combination with e toposide was reached at doses of 200 mg/m(2) paclitaxel (dl) and 100 m g/m(2) etoposide (d2-4). (C) 1998 Elsevier Science Ireland Ltd.