ABSTRACT
The assessment of anticancer agents represents a unique combination of problems in drug development. The treatment of cancer requires compounds which can kill neoplastic human cells with minimum toxicity to normal cells and tissues. The vast majority of active anticancer agents are cytotoxic compounds which have significant side-effects and a very small therapeutic index. Adverse events can reasonably be expected to occur in at least some patients treated with new cytotoxic agents. Trials with these compounds should only be conducted by experienced investigators and at institutions with the facilities to provide adequate care regardless of the toxicity encountered. A primary goal of Phase I cytotoxic drug testing is to determine the maximally tolerated dose of the new agent. It is important to detect the earliest indications of toxicity so that no patient is placed at unwarranted risk for serious complications.
