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

NCT00473954 | Completed Phase 1 DMC

• 1 other identifier: EGEN-001-201
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 4

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

Conditions

Ovarian Neoplasms

Outcome Measures

Primary Outcomes (1)

• 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.

  12-14 months

Secondary Outcomes (1)

• 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.

  10 months

Study Arms (1)

EGEN-001

EXPERIMENTAL

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

Interventions

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

EGEN-001

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;

Sponsors & Collaborators

• EGEN, Inc.: lead

Study Sites (4)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Oncology Specialties, PC

Huntsville, Alabama, 35805, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Interventions

GEN-1

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Study Officials

• Ronald D. Alvarez, MD

  Division of Gynecologic Oncology at University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2007
• First Posted: May 16, 2007
• Study Start: April 1, 2007
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: March 26, 2013

Record last verified: 2013-03

Locations

US (4)