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A Phase II Study of 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea (NSC 9037) in the Palliative Management of Advanced Gastrointestinal Cancer¹

Mayo Clinic, Mayo Foundation, Rochester, Minnesota 55901

1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea was used at a dosage of 130 mg/sq m administered p.o. in the treatment of 51 patients with advanced gastrointestinal carcinoma. Toxicity included transient early nausea and vomiting, thrombocytopenia with a nadir at a median of 28 days, and leukopenia with a nadir at a median of 38 days. One patient died of presumed drug-related, acute hepatic insufficiency. There was a tendency to compounding of hematological toxicity with repeated courses of therapy.

Six patients (12%) showed an objective response greater than 50% at 8 weeks after initiation of treatment. The median duration of these responses was 5 months.

¹ Supported by Grant NIH 70-2066 from the National Cancer Institute, NIH, Bethesda, Md.

Received 2/14/72. Accepted 3/ 7/72.