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

Primary Purpose

Ovarian Neoplasms

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
EGEN-001 (phIL-12-005/PPC)
Sponsored by
EGEN, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ovarian Neoplasms

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Oncology Specialties, PC
  • University of Pennsylvania
  • Baylor College of Medicine

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

EGEN-001

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
May 15, 2007
Last Updated
March 25, 2013
Sponsor
EGEN, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00473954
Brief Title
Safety and Efficacy of EGEN-001 Combined With Carboplatin and Docetaxel in Recurrent, Platinum-Sensitive, Ovarian Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2013
Overall Recruitment Status
Completed
Study Start Date
April 2007 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EGEN, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Neoplasms

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
13 (Actual)

8. Arms, Groups, and Interventions

Arm Title
EGEN-001
Arm Type
Experimental
Intervention Type
Genetic
Intervention Name(s)
EGEN-001 (phIL-12-005/PPC)
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ronald D. Alvarez, MD
Organizational Affiliation
Division of Gynecologic Oncology at University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Facility Name
Oncology Specialties, PC
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35805
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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