A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma
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|ClinicalTrials.gov Identifier: NCT00668499|
Recruitment Status : Withdrawn (Sponsor withdrew support)
First Posted : April 29, 2008
Last Update Posted : May 21, 2014
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.
|Condition or disease||Intervention/treatment||Phase|
|Mesothelioma||Drug: VEGF-Antisense Oligonucleotide , Pemetrexed, Cisplatin||Phase 1 Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||April 2008|
|Estimated Primary Completion Date :||April 2011|
|Estimated Study Completion Date :||April 2011|
- 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
- The primary endpoint of the phase II trial will be time to progression [ Time Frame: Tumor measurements every 6 weeks ]
- Secondary endpoints are objective response rate and overall survival [ Time Frame: Every 6 weeks evaluations ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668499
|United States, California|
|USC/Norris Comprehensive Cancer Center|
|Los Angeles, California, United States, 90033|
|Principal Investigator:||Barbara Gitlitz, MD||University of Southern California|