Summary
The Phase I study of N-7-(p-hydroxyphenyl)-mitomycin C (KW 2083, M 83) was performed. The dose-limiting toxicity was leukopenia and thrombocytopenia and a maximum tolerable dose was 70 mg/m2. Nonhematologic toxicities included nausea (44%), vomiting (13%), diarrhea (2.7%), azotemia (8.1%), proteinuria (5.4%), alopecia (8.1%) and elevated hepatic enzymes (2.7%). This Phase I study indicates that the recommended starting dose for Phase II studies for patients without significant myelosuppression would be 50 mg/m2 at 6 week intervals in an intravenous push. KW 2083 should be avoided in patients with impaired renal functions and proteinuria because of permanent renal damages caused by the drug.
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References
Imai R, Morimoto M, Marumo H, Kobayashi T, Tsuruo T, Inaba M, Tsukagoshi S, Sakurai Y: Antitumor activity of 7-N-(p-hydroxyphenyl)-mitomycin C in experimental tumor system. Gann 72:944–949, 1981
Kobayashi T, Inaba M, Tsukagoshi S, Sakurai Y, Imai R, Morimoto M: Comparison of the hematological toxicity of 7-N-(p-hydroxyphenyl)-mitomycin C and mitomycin C. Gann 72:950–954, 1981
Miyamura S, Niwayama S, Shigeno N: A method for determining the concentration of mitomycin C in body fluids, (in Japanese) J. Antibiotics, Ser. B 14:251–256, 1961
Fujita H: Pharmacokinetics of mitomycin C (MMC) and 7-N- (p-hydroxyphenyl)-mitomycin C (KW 2083) (in Japanese). Gan to Kagakuryoho 9:1362–1373, 1982
Sakurai Y: M-83; A new derivative of mitomycin C. Cancer Treat Symp 1:29–35, 1983
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Meguro, S., Nagata, T., Yokoyama, K. et al. Phase I study of 7-N-(p-hydroxyphenyl)-mitomycin C. Invest New Drugs 2, 381–385 (1984). https://doi.org/10.1007/BF00171589
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DOI: https://doi.org/10.1007/BF00171589