A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma
Tracking Information | |||||
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First Received Date ICMJE | April 25, 2008 | ||||
Last Updated Date | January 8, 2009 | ||||
Start Date ICMJE | April 2008 | ||||
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
The primary endpoint of the phase II trial will be time to progression [ Time Frame: Tumor measurements every 6 weeks ] [ Designated as safety issue: Yes ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | Complete list of historical versions of study NCT00668499 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
Secondary endpoints are objective response rate and overall survival [ Time Frame: Every 6 weeks evaluations ] [ Designated as safety issue: Yes ] | ||||
Original Secondary Outcome Measures ICMJE | Same as current | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | A Study of VEGF-Antisense Oligonucleotide in Combination With Pemetrexed and Cisplatin for the Treatment of Advanced Malignant Mesothelioma | ||||
Official Title ICMJE | 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 | ||||
Brief 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. |
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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. |
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Study Type ICMJE | Interventional | ||||
Study Phase | Phase 1 Phase 2 |
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Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Mesothelioma | ||||
Intervention ICMJE | 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 |
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Study Arm (s) | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Withdrawn | ||||
Estimated Enrollment ICMJE | 71 | ||||
Estimated Completion Date | April 2011 | ||||
Estimated Primary Completion Date | April 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Absolute neutrophil count greater than or equal to1,500 Platelets greater than or equal to 100,000 Total bilirubin less than or equal to2.0x the upper limits of institutional normal AST/ALT less than or equal to 2.0x the upper limits of institutional normal Creatinine Clearance greater than 50ml/min
Exclusion Criteria:
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Gender | Both | ||||
Ages | 18 Years to 90 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00668499 | ||||
Other Study ID Numbers ICMJE | 18M-07-2 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Dr. Barbara Gitlitz, University of Southern California | ||||
Study Sponsor ICMJE | USC/Norris Comprehensive Cancer Center | ||||
Collaborators ICMJE | Sponsor Name Pending | ||||
Investigators ICMJE |
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Information Provided By | USC/Norris Comprehensive Cancer Center | ||||
Verification Date | January 2009 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |