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Clinical Trial
. 2014 Jun;133(3):433-8.
doi: 10.1016/j.ygyno.2014.03.571. Epub 2014 Apr 4.

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

Ronald D Alvarez  1 , Michael W Sill  2 , Susan A Davidson  3 , Carolyn Y Muller  4 , David P Bender  5 , Robert L DeBernardo  6 , Kian Behbakht  3 , Warner K Huh  7
Affiliations
Clinical Trial

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

Ronald D Alvarez et al. Gynecol Oncol. 2014 Jun.

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.

Keywords: Gene therapy; Ovarian cancer; Phase II trial.

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Conflict of interest statement

CONFLICT OF INTEREST

The co-authors have no conflicts of interest to declare.

Figures

Figure 1
Figure 1
Kaplan-Meier plots of A. Progression-free (PFS) and overall survival, and (B) PFS and Event-Free Survival (EFS). The endpoints for EFS are death, progression, or beginning a subsequent therapy.
See this image and copyright information in PMC

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