13
Participants
Start Date
April 30, 2007
Primary Completion Date
November 30, 2009
Study Completion Date
November 30, 2009
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."
University of Pennsylvania, Philadelphia
University of Alabama at Birmingham, Birmingham
Oncology Specialties, PC, Huntsville
Baylor College of Medicine, Houston
EGEN, Inc.
INDUSTRY