ICRF-159 (RAZOXANE) IN PATIENTS WITH ADVANCED SQUAMOUS-CELL CARCINOMA OF THE UTERINE CERVIX - FOR THE GYNECOLOGIC ONCOLOGY GROUP

Patients (31) with advanced squamous cell carcinoma of the cervix were entered into this phase II study evaluating the efficacy of ICRF-159. Three of these patients were excluded; 1 had no tumor, 1 had a second primary and 1 received no therapy. ICRF-159 was administered orally at a dose of 2.5 g/m2 weekly until progression, unacceptable toxicity or death. Adverse effects were primarily hematologic in nature. Of the 28 patients, 23 exhibited leukopenia, which in 10 instances was severe (below 2000/mm3). Seven cases had thrombocytopenia (1 case below 50,000/mm3). Other toxicity, including fever and anorexia, was mild to moderate. There was tumor response in 5 (18%) patients (1 CR [complete response], 4 PR [partial response]) ranging from 1-5 mo. Fifteen patients with stable disease and 8 with progressive disease had a median survival duration of 3.8+ mo. 3.5+ mo., respectively. ICRF-159 showed limited activity in this patient population. However, it might be considered for combination with other low myelosuppressive agents.