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| Sponsors and Collaborators: |
USC/Norris Comprehensive Cancer Center Sponsor Name Pending |
|---|---|
| Information provided by: | USC/Norris Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00668499 |
Purpose
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 | Intervention | Phase |
|---|---|---|
|
Mesothelioma |
Drug: VEGF-Antisense Oligonucleotide , Pemetrexed, Cisplatin |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Safety/Efficacy Study |
| 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 |
| Estimated Enrollment: | 71 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | April 2011 |
| Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
Contacts and Locations| United States, California | |
| USC/Norris Comprehensive Cancer Center | |
| Los Angeles, California, United States, 90033 | |
| Principal Investigator: | Barbara Gitlitz, MD | University of Southern California |
More Information
| Responsible Party: | University of Southern California ( Dr. Barbara Gitlitz ) |
| Study ID Numbers: | 18M-07-2 |
| Study First Received: | April 25, 2008 |
| Last Updated: | January 8, 2009 |
| ClinicalTrials.gov Identifier: | NCT00668499 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Antimetabolites Folic Acid Pemetrexed Radiation-Sensitizing Agents Cisplatin Folate |
Mesothelioma Folinic Acid Folic Acid Antagonists Adenoma Vitamin B9 Neoplasms, Glandular and Epithelial |
|
Antimetabolites Antimetabolites, Antineoplastic Neoplasms by Histologic Type Molecular Mechanisms of Pharmacological Action Neoplasms, Mesothelial Antineoplastic Agents Physiological Effects of Drugs Enzyme Inhibitors Folic Acid Antagonists |
Pharmacologic Actions Pemetrexed Neoplasms Cisplatin Radiation-Sensitizing Agents Therapeutic Uses Mesothelioma Adenoma Neoplasms, Glandular and Epithelial |