Phase I study of maytansine using a 3-day schedule

Cancer Treat Rep. 1978 Mar;62(3):425-8.

Abstract

Maytansine, a new ansa macrolide antitumor antibiotic, was administered to 60 patients as part of a phase I study. The doses given ranged from 0.01 (starting level) to 0.9 mg/m2 for 3 days. The toxic effects encountered consisted principally of nausea, vomiting, diarrhea, and occasionally, stomatitis and alopecia. Superficial phlebitis was also encountered and occurred when the drug was diluted in a volume of less than 250 ml. Myelosuppression occurred infrequently; it was almost regularly associated with abnormal liver function tests. Antitumor activity was detected in one patient each with melanoma, breast carcinoma; and head and neck clear cell carcinoma. Further studies are indicated with this compound since it has shown evidence of activity with little or no myelosuppression.

Publication types

  • Clinical Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Blood Cell Count
  • Bone Marrow Diseases / chemically induced
  • Clinical Trials as Topic
  • Drug Evaluation
  • Humans
  • Liver Function Tests
  • Maytansine / adverse effects
  • Maytansine / therapeutic use*
  • Neoplasms / drug therapy*
  • Oxazines / therapeutic use*

Substances

  • Oxazines
  • Maytansine