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

NCT ID: NCT00473954

Last Updated: 2013-03-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-30
• Study Completion Date: 2009-11-30

Brief Summary

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

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.

Conditions

Ovarian Neoplasms

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

EGEN-001

Group Type: EXPERIMENTAL

EGEN-001 (phIL-12-005/PPC)

Intervention Type: GENETIC

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.

Interventions

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.

Intervention Type: GENETIC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

EGEN, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ronald D. Alvarez, MD

Role: PRINCIPAL_INVESTIGATOR

Division of Gynecologic Oncology at University of Alabama at Birmingham

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Oncology Specialties, PC

Huntsville, Alabama, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

Baylor College of Medicine

Houston, Texas, United States

Countries

United States

Other Identifiers

EGEN-001-201

Identifier Type: -

Identifier Source: org_study_id