• Clin Cancer Res · Mar 2002

    Clinical Trial

    A Phase I study of bizelesin (NSC 615291) in patients with advanced solid tumors.

    • Henry C Pitot, Joel M Reid, Jeff A Sloan, Matthew M Ames, Alex A Adjei, Joseph Rubin, Pamela G Bagniewski, Pamela Atherton, Daniel Rayson, Richard M Goldberg, and Charles Erlichman.
    • Division of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. pitot.henry@mayo.edu
    • Clin Cancer Res. 2002 Mar 1; 8 (3): 712-7.

    PurposeTo evaluate the toxicities, characterize the pharmacokinetics, and determine the maximum-tolerated dose of bizelesin administered once every 4 weeks.Patients And MethodsPatients with advanced solid tumors received escalating doses of bizelesin as an i.v. push every 4 weeks. Pharmacokinetic studies were performed with the first treatment cycle.ResultsNineteen eligible patients received a total of 54 courses of bizelesin at doses ranging from 0.1 to 1 microg/m(2). Dose-limiting toxicity of neutropenia was seen in 2 of 4 patients treated at the 1 microg/m(2) dose level. Nonhematological toxicity was generally mild with maximum toxicity being ConclusionBizelesin administered every 4 weeks as an i.v. push is well tolerated with dose-limiting toxicity of neutropenia. The maximum-tolerated dose (and recommended Phase II dose) is 0.8 microg/m(2) administered once every 4 weeks.

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