title: A randomized phase II trial of trimetrexate or didemnin B for the treatment of metastatic or recurrent squamous carcinoma of the uterine cervix: a Southwest Oncology Group trial.
abstract: Patients with measurable metastatic or recurrent squamous carcinoma of the uterine cervix who had failed prior surgery or radiation therapy were enrolled on this randomized phase II study. Twenty-seven eligible patients were assigned to receive didemnin B at either 2.6 mg/m2 iv every 28 days (sixteen patients) or at 5.6 mg/m2 (eleven patients). Sixteen patients were assigned to receive 12 mg/m2/day iv trimetrexate for 5 days, repeated every 21 days. Toxicity for didemnin B was characterized by nausea and vomiting (78% of patients), anemia (59%), mild diarrhea (11%), and episodic hypersensitivity (three patients). Toxicity for trimetrexate included nausea and vomiting (69%), leukopenia (51%), mild thrombocytopenia (38%), anemia (63%), and diarrhea (31%). No antitumor responses were observed for either agent. Neither trimetrexate nor didemnin B at these doses and schedules is recommended for the treatment of advanced squamous carcinoma of the uterine cervix.
authors.affiliation: University of Texas Health Science Center, San Antonio 78284-7884.
authors.forename: G R
authors.initials: GR
authors.lastname: Weiss
authors.forename: P Y
authors.initials: PY
authors.lastname: Liu
authors.forename: J
authors.initials: J
authors.lastname: O'Sullivan
authors.forename: D S
authors.initials: DS
authors.lastname: Alberts
authors.forename: T D
authors.initials: TD
authors.lastname: Brown
authors.forename: J R
authors.initials: JR
authors.lastname: Neefe
authors.forename: L F
authors.initials: LF
authors.lastname: Hutchins
mesh_terms: D000970:Antineoplastic Agents / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000556:secondary; D047630:Depsipeptides; D005260:Female; D006801:Humans; D009364:Neoplasm Recurrence, Local; D010456:Peptides, Cyclic / Q000009:adverse effects / Q000627:therapeutic use*; D016597:Trimetrexate / Q000009:adverse effects / Q000627:therapeutic use*; D002583:Uterine Cervical Neoplasms / Q000188:drug therapy* / Q000556:secondary
chemical_list: D000970:Antineoplastic Agents; D047630:Depsipeptides; D010456:Peptides, Cyclic; C030051:didemnins; D016597:Trimetrexate