A prospective clinical trial of lenalidomide with topotecan in women with advanced epithelial ovarian carcinoma

Jori S. Carter, Levi S Downs

Research output: Contribution to journalArticlepeer-review

6 Scopus citations


Background: Lenalidomide is an anti-angiogenic IMiD ® immunomodulatory drug. The objective of this study was to determine the maximum tolerated dose (MTD), overall safety profile, and activity of oral lenalidomide in combination with topotecan in women with advanced epithelial ovarian or primary peritoneal carcinoma. Methods: In this Phase I/II open-label, dose-escalation study, patients with histologically or cytologically confirmed advanced ovarian or primary peritoneal carcinoma with disease progression or recurrence following first-line therapy with a platinum agent and paclitaxel were eligible. The Phase I trial utilized a standard dose-escalation design to define the MTD and evaluate the safety profile of lenalidomide and topotecan. The starting doses were lenalidomide 5 mg, days 1-14, and intravenous topotecan 1.25 mg/m 2, days 1-5 of a 21-day cycle. Only the lenalidomide dose was escalated, in 5-mg increments up to 25 mg. Toxicity was graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events. The Phase II portion was designed to evaluate the antitumor activity based on objective response rate of lenalidomide and topotecan. Results: Five women with advanced epithelial ovarian carcinoma were enrolled, each receiving 5 mg oral lenalidomide and 1.25 mg/m 2 topotecan. Four patients discontinued because of dose-limiting toxicity, most commonly grade 4 neutropenia (n = 3). One patient discontinued because of lack of therapeutic effect. The study was terminated early for reasons of toxicity. Conclusion: The addition of lenalidomide to topotecan is not a feasible drug combination in women with advanced epithelial ovarian carcinoma because of dose-limiting toxicity.

Original languageEnglish (US)
Pages (from-to)666-670
Number of pages5
JournalInternational Journal of Clinical Oncology
Issue number6
StatePublished - Dec 2011

Bibliographical note

Funding Information:
The authors received editorial and formatting support from Excerpta Medica in the preparation of this manuscript, funded by Celgene Corporation, Summit, NJ, USA. The authors were fully responsible for content and editorial decisions for this manuscript. J.S.C. was supported by Award Number T32CA132715 from the National Cancer Institute. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Cancer Institute or the National Institutes of Health.


  • Advanced epithelial ovarian carcinoma
  • Lenalidomide
  • Neutropenia
  • Safety
  • Topotecan


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