A randomized phase II study with two schedules of the novel indoloquinone EO9 in non-small-cell lung cancer: A study of the EORTC early clinical studies group (ECSG)
Date
1996Author
Pavlidis, NicholasHanauske, A. R.
Gamucci, T.
Smyth, J. F.
Lehnert, M.
Velde, A. Te
Lan, J.
Verweij, J.
Source
Annals of OncologyVolume
7Issue
5Pages
529-531Google Scholar check
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In a multicentre randomized trial of the EORTC-ECSG, we have treated 38 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/m2 weekly and arm B 22 mg/m2 every three weeks. All together 185 courses were administered (145 in arm A and 40 in arm B). The major toxicity was reversible proteinuria more frequently occurring in the three-weekly schedule (arm A 34.5% vs. arm B 62.5%). Creatinine elevation, fluid retention and pericardial or pleural effusion were also recorded in a limited number of patients. Other common toxicities more frequent in the three-weekly administration were asthenia (21% vs. 35% of cycles), nausea (15% vs. 27.5% of cycles) and Vomiting (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 schedules of EO9 do not yield activity in NSCLC.
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