A phase II evaluation of mitolactol in patients with advanced squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study.
Sixty patients with advanced squamous cell carcinoma of the cervix (SCC) who had received no prior chemotherapy were entered onto a study of mitolactol (dibromodulcitol [DBD]). The drug was administered orally at an initial dose of 180 mg/m2 per day for 10 days and repeated every 4 weeks. There were 55 evaluable patients, of whom one (2%) had a complete response (CR), and 15 (27%) had a partial response (PR), (CR plus PR, 29%). A 95% confidence interval for the true response rate is 18.8% to 42.1%. Myelosuppression was appreciable at this dose and schedule, with 13 patients experiencing life-threatening thrombocytopenia and two drug-related deaths. The level of activity in this disease encourages us to determine a tolerable dose of this drug in combination with cisplatin for further study.
Stehman
F B
FB
Department of Gynecologic Oncology, Indiana University Medical Center, Indianapolis.
Blessing
J A
JA
McGehee
R
R
Barrett
R J
RJ
D000328:Adult; D000368:Aged; D001853:Bone Marrow / Q000187:drug effects; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008875:Middle Aged; D008936:Mitolactol / Q000009:adverse effects / Q000627:therapeutic use*; D015337:Multicenter Studies as Topic; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
D008936:Mitolactol