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[Early phase II study of the combined use of AO-90 methionine-free amino acid solution and anticancer agents (5-FU and MMC) in patients with advanced and recurrent gastrointestinal cancer. AO-90 Study group].

Early phase II study in patients with advanced and recurrent gastrointestinal cancer was conducted from August 1986 through December 1987 to evaluate synergic effect of the combined use of AO-90 amino acid solution (free from Methionine) and anticancer agents (5-FU and MMC). Thirty five patients were subjected to the clinical evaluation according to the two criteria, i.e., the solid cancer chemotherapy direct efficacy criteria and the criteria of improvement of gastrointestinal passage disorder. Among 21 patients appropriately eligible for the direct efficacy criteria, the rate of more than partial response was 23.8% (5/21), while the rate of 27.8% (5/18) was observed in the patients who completely met the evaluation requirements. Among 14 patients with gastrointestinal passage disorder due to cancer, 57.1% (8/14) of the patients effectively responded to the therapy.