A RANDOMIZED PHASE-II STUDY WITH 2 SCHEDULES OF THE NOVEL INDOLOQUINONE-EO9 IN NON-SMALL-CELL LUNG-CANCER - A STUDY OF THE EORTC EARLY CLINICAL-STUDIES GROUP (ECSG)

In a multicentre randomized trial of the EORTC-ECSG, we have treated 3 8 chemotherapy naive patients with advanced non-small-cell lung cancer (NSCLC) with EO9, a novel bioreductive alkylating indoloquinone. The drug was given at two different dose schedules by a single bolus i.v. injection: arm A 12 mg/m(2) weekly and arm B 22 mg/m(2) every three we eks. All together 185 courses were administered (145 in arm A and 40 i n arm B). The major toxicity was reversible proteinuria more frequentl y occurring in the three-weekly schedule (arm A 34.5% vs. arm B 62.5%) . Creatinine elevation, fluid retention and pericardial or pleural eff usion were also recorded in a limited number of patients. Other common toxicities more frequent in the three-weekly administration were asth enia (21% vs. 35% of cycles), nausea (15% vs. 27.5% of cycles) and vom iting (5% vs. 17.5% of cycles). Toxicities were mainly of grade I and II. No responses have been observed. Five patients (26%) on arm A and eight (53%) on arm B experienced stable disease. These doses and sched ules of EO9 do not yield activity in NSCLC.