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Difficulties Designing Clinical Trials as Exemplified by a Phase 2 Drug Evaluation of 5[3,3-Bis(2-chloroethyl)-1-triazenol]-imidazole-4-carboxamide and 1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea in Patients with Disseminated Breast Cancer¹

Division of Medical Oncology and Internal Medicine, Mayo Clinic, Rochester, Minnesota 55901

Two drugs, 5-[3,3-bis(2-chloroethyl)-1-triazenol]-imidazole-4-carboxamide [TIC-Mustard (NSC 82196)] and 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea (NSC 79037), were evaluated in 41 patients with disseminated breast cancer in a prospective randomized clinical trial. None of these patients had previous exposure to cytotoxic chemotherapy. Two of 20 patients experienced objective regressions with TIC-Mustard and 2 of 21 did for 1-(2-chloroethyl)-3-cyclohexyl-1-nitrosourea. Toxicity for both agents included nausea, vomiting, myelosuppression, and alopecia. The use of TIC-Mustard resulted in phlebitis in 11 of 20 patients often followed by sclerosis of the veins. This study raises some questions as to the validity of present sampling techniques in Phase 2 clinical trials in patients with disseminated breast cancer and these are discussed.

¹ Supported by Research Contract NIH-71-2185.

Received 8/28/72. Accepted 3/29/73.