Leo 1031 (NSC-134087) in gynecologic malignancies

Thirty-nine patients with gynecological malignancies who had failed on conventional chemotherapeutic agents were treated with Leo 1031 to study the effective dosage and toxicity of the compound in gynecological malignancies. Six patients with ovarian adenocarcinoma were also treated subsequently by using this compound as primary therapy. Comparable results (33% response rate) were obtained with excellent subjective response rate) were obtained with excellent subjective response and minimal hematologic toxicity. Leo 1031 given 30 mg per day was well tolerated by most of the patients but increasing the dose to 40 mg per day led to development of severe hematologic toxicity with no change in response rate. No patients developed clinical evidence of steroid toxicity.