Phase I study of hycanthone.

Abstract

Hycanthone was given to 15 patients with metastatic cancer in order to determine the maximum tolerable dose. The drug was administered in 5-day courses at 3-week intervals. The starting dose was 30 mg/m2/day and the highest dose level reached was 90 mg/m2/day. The most common (13 patients) side effect was nausea and/or vomiting. The dose-limiting toxicity was toxic hepatitis manifested as elevation in serum transaminases in eight of 15 patients and an increase in serum bilirubin in three patients. Hepatotoxicity was dose-related and was observed in two of 25 courses given at the dose level of less than or equal to 70 mg/m2 compared to seven of nine courses given at the dose level of greater than or equal to 80 mg/m2. Because of an unacceptable incidence of hepatotoxicity at higher doses, 70 mg/m2/day x 5 appears to be a safe dose for phase II studies.

• Authors: S S Legha, W E Grose, G P Bodey
• Journal: Cancer treatment reports (Cancer Treat Rep) Vol. 62 Issue 8 Pg. 1173-6 (Aug 1978) ISSN: 0361-5960 [Print] United States
• PMID: 356976 (Publication Type: Clinical Trial, Journal Article, Research Support, U.S. Gov't, P.H.S.)

Chemical References

• Thioxanthenes
• Hycanthone

Topics

• Adult
• Aged
• Chemical and Drug Induced Liver Injury (etiology)
• Clinical Trials as Topic
• Drug Administration Schedule
• Drug Evaluation
• Female
• Humans
• Hycanthone (administration & dosage, adverse effects, therapeutic use)
• Male
• Middle Aged
• Neoplasms (drug therapy)
• Thioxanthenes (therapeutic use)