Safety and Efficacy of EGEN-001 Combined With Carboplatin and Docetaxel in Recurrent, Platinum-Sensitive, Ovarian Cancer

March 25, 2013 updated by: EGEN, Inc.

A Phase 1, Open-Label, Dose Escalation Study of the Safety and Preliminary Efficacy of EGEN-001 in Combination With Carboplatin and Docetaxel in Women With Recurrent, Platinum-Sensitive, Epithelial Ovarian Cancer

Ovarian cancer may be caused by a build-up of genetic defects, or damaged genes within the body's cells. When genes are damaged, the body may be unable to produce a group of proteins, called cytokines, used by the immune system to fight cancer and some infections. The investigational gene transfer agent EGEN-001 contains the human gene for the cytokine interleukin-12 (IL-12) in a special carrier system designed to enter the cells and help the body to produce cytokines. Therefore, the purpose of the EGEN-001 therapy is to attempt to enhance the body's natural ability to recognize and fight cancer cells. Funding Source - FDA OOPD

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study has two purposes:

  • To determine what different strengths and number of doses of EGEN-001, administered directly into the peritoneal cavity, can be given safely in combination with standard intravenous chemotherapy for ovarian cancer
  • To evaluate the anti-cancer activity of EGEN-001 when combined with standard chemotherapy; biological markers of EGEN-001 activity will be collected and ovarian cancer burden will be evaluated per standard practice.

Study Type

Interventional

Enrollment (Actual)

13

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • University of Alabama at Birmingham
      • Huntsville, Alabama, United States, 35805
        • Oncology Specialties, PC
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
    • Texas
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Be female and at least 18 years of age (or minimum legal age and competency to provide voluntary written informed consent for study participation);
  • Histologically/cytologically confirmed epithelial ovarian cancer that meets one of the following criteria:
  • measurable disease by computed tomography (CT) scan or
  • malignant ascites, or
  • Serum CA-125 levels; or
  • Clinically evaluable recurrent disease by other criteria.
  • Relapsed, platinum-sensitive, ovarian cancer after induction chemotherapy (at least 6 months since last exposure to platinum based therapy).
  • Eastern Cooperative Oncology Group (ECOG) Performance score of 0, 1 or 2;
  • Recovered from prior chemotherapy, having adequate bone marrow function:
  • Adequate renal function;
  • Adequate liver function;
  • If of childbearing potential, have a negative pregnancy test and agree to follow an acceptable method of birth control;
  • Agree to be compliant with the study's requirements;
  • Understand and sign a written Informed Consent prior to the performance of any study-related procedures.

Exclusion Criteria:

  • Ovarian cancer other than documented epithelial cancer;
  • Intra-abdominal disease > 5 cm in diameter;

  • Any serious, uncontrolled, intercurrent medical illness or disorder including, but not limited to:

    • Autoimmune disorders
    • Cardiac Disorders
    • Diabetes
    • Intrahepatic disease/cancer as documented by CT-scan
  • An active infection within 4 weeks of study entry;
  • Any condition/anomaly that would interfere with the appropriate placement of the IP catheter for study drug administration
  • Prior treatment with whole abdominal irradiation;
  • Currently receiving or have received any investigational agents within 28 days of study entry;
  • Received prior chemotherapy for ovarian cancer administered by the IP route;
  • Received any chemotherapy between completion of primary chemotherapy for ovarian cancer and study entry (e.g. consolidation therapy);
  • Receipt of immunotherapy and/or any medications with the potential to affect the activity of EGEN 001;
  • Known history of HIV infection, hepatitis B, or hepatitis C;
  • Known hypersensitivity to any of the components of carboplatin or docetaxel;
  • Life expectancy of less than 3 months;
  • Known, current, recreational drug or alcohol abuse;
  • Breast feeding an infant;
  • Psychiatric illness/social situations which would limit compliance with study requirements;
  • Any other known condition which in the Investigator's opinion would make the patient a poor candidate for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: EGEN-001
Genetic: EGEN-001 (phIL-12-005/PPC)

In stage 1, patients will receive standard doses of IV carboplatin and docetaxel for 2 treatment cycles with a 3 week interval. Patients will also receive 4 IP infusions of EGEN-001 at 12mg/m2 EGEN-001, 18mg/m2, or 24mg/m2, 10-11 days apart.

Stage 2 of the study will involve cycle escalation at the highest EGEN-001 dose identified from Stage 1. All patients will receive up to 8 doses of EGEN-001, 10-11 days apart plus up to 4 IV carboplatin and docetaxel cycles with 3 week intervals. After receiving the assigned number of treatments of EGEN-001, carboplatin, and docetaxel, patients may continue to receive up to 4 additional infusions of EGEN-001 and 2 IV carboplatin and docetaxel cycles with 3 week intervals.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Determine the MTD and treatment-related toxicities of intra-peritoneal (IP) infusion of EGEN-001 in combination with carboplatin and docetaxel for recurrent, platinum-sensitive, ovarian cancer.
Time Frame: 12-14 months
12-14 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Examine the optimal EGEN-001 treatment regimen in combination with carboplatin and docetaxel in recurrent, platinum-sensitive ovarian cancer, and assess EGEN-001's impact on tumor, CA-125, and activity markers of biological activity.
Time Frame: 10 months
10 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

EGEN, Inc.

Investigators

  • Principal Investigator: Ronald D. Alvarez, MD, Division of Gynecologic Oncology at University of Alabama at Birmingham

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2007

Primary Completion (Actual)

November 1, 2009

Study Completion (Actual)

November 1, 2009

Study Registration Dates

First Submitted

May 15, 2007

First Submitted That Met QC Criteria

May 15, 2007

First Posted (Estimate)

May 16, 2007

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 25, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EGEN-001-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Ovarian Neoplasms

Clinical Trials on EGEN-001 (phIL-12-005/PPC)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Dominican Republic

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe