title: A phase II evaluation of mitolactol in patients with advanced squamous cell carcinoma of the cervix: a Gynecologic Oncology Group Study.
abstract: 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.
authors.affiliation: Department of Gynecologic Oncology, Indiana University Medical Center, Indianapolis.
authors.forename: F B
authors.initials: FB
authors.lastname: Stehman
authors.forename: J A
authors.initials: JA
authors.lastname: Blessing
authors.forename: R
authors.initials: R
authors.lastname: McGehee
authors.forename: R J
authors.initials: RJ
authors.lastname: Barrett
mesh_terms: 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*
chemical_list: D008936:Mitolactol