Phase I study of 7-N-(p-hydroxyphenyl)-mitomycin C.
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.
D000368:Aged; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy; D003110:Colonic Neoplasms / Q000188:drug therapy; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008175:Lung Neoplasms / Q000188:drug therapy; D008297:Male; D008875:Middle Aged; D016685:Mitomycin; D008937:Mitomycins / Q000009:adverse effects / Q000378:metabolism / Q000627:therapeutic use*; D010190:Pancreatic Neoplasms / Q000188:drug therapy; D013274:Stomach Neoplasms / Q000188:drug therapy
D000970:Antineoplastic Agents; D008937:Mitomycins; D016685:Mitomycin; C027281:7-N-(4-hydroxyphenyl)mitomycin C