title: A phase II study of fazarabine (NSC 281272) in patients with advanced squamous cell carcinoma of the cervix. A Gynecologic Oncology Group study.
abstract: Promising preclinical data and reasonable toxicity in Phase I trials encouraged the Gynecologic Oncology Group to study Fazarabine (FZB) in patients with recurrent squamous cell cancer of the cervix. Twenty-three patients with histologically proven recurrent cervical cancer with measurable disease received FZB at a dosage of 30 mg/m2 per day for 5 days; cycles repeated every 28 days. In the absence of grade 3 or 4 toxicity, dose escalation was planned to a maximum dose of 40 mg/m2 per day for 5 days. All patients were evaluable for toxicity. Seven patients developed neutropenia; in two instances, it was considered life-threatening. The only other serious adverse effect was seen in one patient who developed grade 4 nephrotoxicity. Nineteen women who had failed prior chemotherapy were evaluable for response. There were no complete or partial responses; and seven had stable disease. Fazarabine exhibits no demonstrable activity in this patient population at the dose and schedule tested and further clinical trials as second-line chemotherapy are not warranted.
authors.affiliation: Division of Gynecologic Oncology, University of California, Irvine Medical Center 92668, USA.
authors.forename: A
authors.initials: A
authors.lastname: Manetta
authors.forename: J A
authors.initials: JA
authors.lastname: Blessing
authors.forename: W J
authors.initials: WJ
authors.lastname: Mann
authors.forename: D M
authors.initials: DM
authors.lastname: Smith
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001374:Azacitidine / Q000008:administration & dosage / Q000031:analogs & derivatives* / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy*; D005260:Female; D006801:Humans; D008875:Middle Aged; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; C022121:fazarabine; D001374:Azacitidine