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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
EGEN, Inc.
ClinicalTrials.gov Identifier:
NCT00473954
First received: May 15, 2007
Last updated: March 25, 2013
Last verified: March 2013

May 15, 2007
March 25, 2013
April 2007
November 2009   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
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.
Complete list of historical versions of study NCT00473954 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: Yes ]
Examine the optimal EGEN 001 treatment (and related toxicities) in combination with carboplatin and docetaxel in recurrent, platinum-sensitive ovarian cancer, and perform assessments of EGEN-001’s impact on tumor, CA-125, and activity markers in blood a
Not Provided
Not Provided
 
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.
Interventional
Phase 1
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Ovarian Neoplasms
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.

Experimental: EGEN-001
Intervention: Genetic: EGEN-001 (phIL-12-005/PPC)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
13
November 2009
November 2009   (final data collection date for primary outcome measure)

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.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00473954
EGEN-001-201
Yes
EGEN, Inc.
EGEN, Inc.
Not Provided
Principal Investigator: Ronald D. Alvarez, MD Division of Gynecologic Oncology at University of Alabama at Birmingham
EGEN, Inc.
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP