Mesothelioma Clinical Trial
Official title:
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
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.
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
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