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

PHASE1CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

April 30, 2007

Primary Completion Date

November 30, 2009

Study Completion Date

November 30, 2009

Conditions
Ovarian Neoplasms
Interventions
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."

Trial Locations (4)

19104

University of Pennsylvania, Philadelphia

35233

University of Alabama at Birmingham, Birmingham

35805

Oncology Specialties, PC, Huntsville

77030

Baylor College of Medicine, Houston

All Listed Sponsors
lead

EGEN, Inc.

INDUSTRY

NCT00473954 - Safety and Efficacy of EGEN-001 Combined With Carboplatin and Docetaxel in Recurrent, Platinum-Sensitive, Ovarian Cancer | Biotech Hunter | Biotech Hunter