A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted, membrane-disrupting peptide, versus paclitaxel alone for refractory or recurrent ovarian cancer

Anca Chelariu-Raicu, Alpa Nick, Renata Urban, Mary Gordinier, Carola Leuschner, Linda Bavisotto, Graziela Zibetti Dal Molin, John K. Whisnant, Robert L. Coleman

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: This randomized open-label phase II study evaluated the safety and clinical activity of EP-100 plus weekly paclitaxel in patients with recurrent ovarian cancer expressing positive LHRH receptor. Methods: In a limited “run-in” dose escalation phase for EP-100, six patients were treated with ascending dose levels (13 mg/m2, 20 mg/m2, 30 mg/m2). In the randomized phase, patients received weekly paclitaxel (80 mg/m2 intravenously) plus twice weekly EP-100 (30 mg/m2 intravenously; combination arm) or weekly paclitaxel alone (80 mg/m2 intravenously; paclitaxel arm). The primary study endpoint was overall response rate (ORR). Results: Forty-four patients were then randomized to either the experimental combination arm (n = 23) or the standard of care paclitaxel monotherapy arm (n = 21). The ORR was 35% (95%CI 16%–57%) for the combination arm and 33% (95% CI 15%–57%) for the paclitaxel arm. An interesting observation from an unplanned analysis was that a subset of patients with target liver lesions showed a greater overall response rate to the combination (69%) compared to paclitaxel alone (16%). The frequency of treatment-related grade 3–4 adverse events was similar between treatment arms: 48% vs 43% for the combination and paclitaxel arms, respectively. Conclusions: ORR in the EP-100 combination arm was similar to that in the group treated with paclitaxel alone; however, a subset of patients with liver metastases appeared to benefit from the combination. The addition of EP-100 did not appear to augment the adverse event profile of paclitaxel and was well tolerated.

Original languageEnglish (US)
Pages (from-to)418-426
Number of pages9
JournalGynecologic oncology
Volume160
Issue number2
DOIs
StatePublished - Feb 2021

Keywords

  • EP-100
  • LHRH receptor
  • Paclitaxel
  • Recurrent ovarian cancer

ASJC Scopus subject areas

  • Oncology
  • Obstetrics and Gynecology

Fingerprint Dive into the research topics of 'A multicenter open-label randomized phase II trial of paclitaxel plus EP-100, a novel LHRH receptor-targeted, membrane-disrupting peptide, versus paclitaxel alone for refractory or recurrent ovarian cancer'. Together they form a unique fingerprint.

Cite this