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

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

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.

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.