Abstract
One of the main goals of research oncologists is to identify agents that demonstrate antitumor activity and to translate this property into prolonged survival leading to increased cure rates. Phase II trials were instituted to facilitate this process and are designed as preliminary clinical screening of a new regimen in a homogeneous patient population with a particular tumor type. The decision to pursue or discontinue the treatment depends on the outcome of the evaluation. Ideally, treatments that do not yield a required level of effectiveness should be used in the smallest number of patients. On the other hand, considering the enormous progress that remains to be achieved in cancer chemotherapy, the most serious failure of a phase II trial is to reject a useful compound. Once a drug is labeled inactive, future development is unlikely.
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Scher, H.I., Geller, N.L., Muggia, F.M., Rozencweig, M. (1987). Clinical Evaluation of Anticancer Treatments: Phase II Clinical Trials. In: Muggia, F.M., Rozencweig, M. (eds) Clinical Evaluation of Antitumor Therapy. Developments in Oncology, vol 46. Springer, Boston, MA. https://doi.org/10.1007/978-1-4613-2317-4_9
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DOI: https://doi.org/10.1007/978-1-4613-2317-4_9
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