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

Gynecol Oncol. 1992 Jun;45(3):303-6. doi: 10.1016/0090-8258(92)90309-7.

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.

Publication types

  • Clinical Trial
  • Randomized Controlled Trial
  • Research Support, U.S. Gov't, P.H.S.

MeSH terms

  • Antineoplastic Agents / therapeutic use
  • Carcinoma, Squamous Cell / drug therapy*
  • Carcinoma, Squamous Cell / secondary
  • Depsipeptides*
  • Female
  • Humans
  • Neoplasm Recurrence, Local
  • Peptides, Cyclic / adverse effects
  • Peptides, Cyclic / therapeutic use*
  • Trimetrexate / adverse effects
  • Trimetrexate / therapeutic use*
  • Uterine Cervical Neoplasms / drug therapy*
  • Uterine Cervical Neoplasms / secondary

Substances

  • Antineoplastic Agents
  • Depsipeptides
  • Peptides, Cyclic
  • didemnins
  • Trimetrexate