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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Ovarian Neoplasms
- Sponsor
- EGEN, Inc.
- Enrollment
- 13
- Locations
- 4
- Primary Endpoint
- 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.
- Status
- Completed
- Last Updated
- 13 years ago
Overview
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.
Investigators
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;
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
- •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;
Outcomes
Primary Outcomes
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 Outcomes
- 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)