IN VITRO DRUG TESTING FOR LIMITED SCLC AND PHASE I DRUG DEVELOPMENT

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A protocol combining twice a day radiotherapy-plus VP 16 and cisplatin for limited stage small cell lung cancer continues. Eighteen patients have been entered onto study and 13 of 14 patients who have completed therapy have achieved a complete remission. 14 of 18 patients are alive and free of cancer or undergoing induction therapy with a median follow up of 10 months. No patients have been hospitalized for combined modality pneumonitis. A phase I trial using dihdrolenperone, an agent identified as being active against human lung cancer by the human tumor colony forming assay (HTCFA) has been initiated. Twenty-three patients have been studied at 6 dosage levels. The principle side effects have been somnolence and hypotension in all patients. Two patients have had to stop therapy because of somnolence and none because of hypotension. Preliminary pharmacokinetic determinations show peak absorption at 3 hours and that level vary less than 50% over the 12 hours dosing interval. From these studies we conclude that the HTCFA has identified a compound with novel side effects and the maximum tolerated dose has not been reached.