NCT00473954

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (actual)
• Sponsor: EGEN, Inc. · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2007-04-01
• Primary completion: 2009-11-01
• Completion: 2009-11-01
• First posted: 2007-05-16
• Last updated: 2013-03-26

Locations

4 sites across 1 country: United States