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A Phase I study of bizelesin (NSC 615291) in patients with advanced solid tumors
Henry C Pitot1, Joel M Reid, Jeff A Sloan
1Division of Medical Oncology, Mayo Clinic and Mayo Foundation, Rochester, Minnesota 55905, USA. pitot.henry@mayo.edu
Purpose:
To evaluate the toxicities, characterize the pharmacokinetics, and determine the maximum-tolerated dose of bizelesin administered once every 4 weeks.
Patients And Methods:
Patients 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.
Results:
Nineteen 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
Conclusion:
Bizelesin 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.