NCT00668499

A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma

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

• Status: Withdrawn
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

This will be a single institution non-randomized phase I/II trial for patients with malignant mesothelioma stage II and above, who have not received prior chemotherapy for their disease. The purpose of this phase is to select a dose of VEGF-AS (antiangiogenesis drug)to be given with standard doses of pemetrexed followed by cisplatin on day 1 of a 21-day cycle.

Detailed description

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.

Conditions

• Mesothelioma

Interventions

Type	Name	Description
DRUG	VEGF-Antisense Oligonucleotide , Pemetrexed, Cisplatin	VEGF-AS either 100 or 200mg/m2 IV days 1-5, Pemetrexed 500mg/m2 and Cisplatin 75mg/m2 IV on day 1. Cycle repeated every 3 weeks until 6 cycles completed, unless PD or toxicities

Timeline

• Start date: 2008-04-01
• Primary completion: 2011-04-01
• Completion: 2011-04-01
• First posted: 2008-04-29
• Last updated: 2014-05-21

Locations

1 site across 1 country: United States