A phase II trial of intraperitoneal EGEN-001, an IL-12 plasmid formulated with PEG-PEI-cholesterol lipopolymer in the treatment of persistent or recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer: a gynecologic oncology group study.

Academic Article

Abstract

  • OBJECTIVE: The purpose of this phase II trial was to evaluate the toxicity and antitumor activity of EGEN-001 in platinum resistant recurrent ovarian cancer. METHODS: Eligible patients had weekly IP infusion of EGEN-001 at a dose of 24mg/m(2). Toxicity and antitumor activity were evaluated using CTCAE and RESIST criteria, respectively. Co-primary endpoints were tumor response and survival without progression (PFS) for at least 6months. Survival without progression before going onto a subsequent therapy (EFS) for at least six months was also considered. RESULTS: A total of 58 EGEN-001 cycles were administered to 20/22 enrolled patients (median 2cycles, range 1-9). The most frequently associated adverse events related specifically to EGEN-001 treatment were grade 1/2 fatigue, fever, chills, abdominal pain, nausea, vomiting, anemia, thrombocytopenia, and leukopenia. Three of 20 EGEN-001 treated patients evaluable for toxicity elected to withdraw from the study motivated in part by grade 1 treatment related toxicities. There were no patients with partial or complete response (0%; 90% CI 0-10.9%). Seven (35%) of 16 patients evaluable for response had stable disease, and 9 (45%) had progressive disease. Six (30%) patients had a PFS of greater than six months, although three had gone off study and onto other therapies before six months. The estimated six-month EFS was 15%. The median PFS and OS were 2.89 and 9.17months, respectively. CONCLUSION: EGEN-001 at the dose and schedule evaluated was associated with some but limited activity and was seemingly less tolerated in platinum resistant recurrent ovarian cancer patients.
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    Keywords

  • Gene therapy, Ovarian cancer, Phase II trial, Adenocarcinoma, Adult, Aged, Carcinoma, Endometrioid, Carcinoma, Ovarian Epithelial, Cholesterol, Cystadenocarcinoma, Serous, Disease-Free Survival, Drug Resistance, Neoplasm, Fallopian Tube Neoplasms, Female, Gene Transfer Techniques, Genetic Therapy, Humans, Infusions, Parenteral, Interleukin-12, Middle Aged, Neoplasm Recurrence, Local, Neoplasms, Glandular and Epithelial, Ovarian Neoplasms, Peritoneal Neoplasms, Plasmids, Polyethylene Glycols, Polyethyleneimine, Treatment Outcome
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    Author List

  • Alvarez RD; Sill MW; Davidson SA; Muller CY; Bender DP; DeBernardo RL; Behbakht K; Huh WK
  • Start Page

  • 433
  • End Page

  • 438
  • Volume

  • 133
  • Issue

  • 3