Phase I evaluation of chlorozotocin: single dose every six weeks.

A phase I trial of chlorozotocin was completed for the single dose every six week schedule. At 250 mg/m2 i.v. push, excessive thrombocytopenia, nausea, and anorexia occurred. Two cases of cholestatic jaundice were seen, and one patient had worsening of his diabetes mellitus after one course. Partial response or prolonged disease stabilization with increased survival was documented in four of seven patients with non-small cell carcinoma of the lung. A starting dose of 225 mg/m2 is recommended for good risk patients with little or no prior bone marrow toxicity from chemotherapy or irradiation. A dose of 200 mg/m2 is recommended for patients with limited previous treatment and good bone marrow reserve.