Phase II study of i.v. CI-980 in patients with advanced platinum refractory epithelial ovarian carcinoma

Andrzej P. Kudelka, Annette Hasenburg, Claire F. Verschraegen, Creighton L. Edwards, Christina A. Meyers, Datla Varma, Ralph S. Freedman, Arthur Forman, Charles A. Conrad, William Grove, Axel Grothey, John J. Kavanagh

Research output: Contribution to journalArticlepeer-review

12 Scopus citations

Abstract

CI-980 is a synthetic mitotic inhibitor that binds to tubulin at the colchicine site, inhibiting the polymerization of microtubules and arresting cellular division in metaphase. Myelosuppression and neurotoxicity were dose-limiting in phase I studies. Sixteen patients with stage III and IV platinum-refractory ovarian cancer received 4.5 mg/m2/day of CI-980 as a continuous i.v. infusion for 72 h, repeated every 3 weeks. Eleven patients had progression and four patients had stable disease. One patient (6%; 95% CI 0-25%) achieved a partial response after 9 months of treatment which lasted for 27 months. The overall median survival was 7 months. Grade 4 granulocytopenia occurred in five patients, with two episodes of neutropenic fever. Neurological toxicity was mild with 12 episodes of transient subclinical recent memory loss documented in four patients by specialized neuropsychological evaluations. One patient each had hallucinations and mild truncal ataxia, and four patients had mild, reversible neurosensory toxicity. One episode of severe hypoxemia and dyspnea occurred in a patient with chronic obstructive pulmonary disease. CI-980 has minimal activity and is tolerable in a population of heavily pretreated patients with platinum refractory ovarian cancer.

Original languageEnglish (US)
Pages (from-to)405-409
Number of pages5
JournalAnti-cancer drugs
Volume9
Issue number5
DOIs
StatePublished - Jun 25 1998

Keywords

  • CI-980
  • CNS toxicity
  • Phlebitis tubulin binder
  • Platinum refractory ovarian cancer

ASJC Scopus subject areas

  • Oncology
  • Pharmacology
  • Pharmacology (medical)
  • Cancer Research

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