A Phase I/II Study of VEGF-Antisense Oligonucleotide (VEGF-AS, Veglin) in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma
The Study Objectives in Phase I are:
To determine the safety of the combination of VEGF-Antisense Oligonucleotide (VEGF-AS,
Veglin™) plus Pemetrexed and Cisplatin in subjects with advanced Malignant Mesothelioma,.via
a dose escalation protocol. To determine the Maximum Tolerated Dose (MTD) and Dose Limiting
Toxicity (DLT) of VEGF-AS plus Premetrexed and Cisplatin. To determine the time to disease
progression To determine the objective response rate of the combination of VEGF-AS plus
Pemetrexed and Cisplatin for the treatment of advanced malignant mesothelioma
The study Objectives in Phase II are:
To further characterize the toxicity experienced by patients with malignant mesothelioma
treated with VEGF-AS plus Cisplatin and Pemetrexed.
To determine median and overall survival.
The Laboratory objectives are:
To measure plasma VEGF levels before, during, and after therapy as a correlate of outcome.
To determine the pharmacokinetic profile of VEGF-AS plus Pemetrexed and Cisplatin.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary endpoint of the phase II trial will be time to progression
Tumor measurements every 6 weeks
Barbara Gitlitz, MD
University of Southern California
United States: Institutional Review Board
|USC/Norris Comprehensive Cancer Center||Los Angeles, California 90033-0800|