Condition
Non-Small Cell Lung Cancer and Pleural Mesothelioma
Estimated Enrollment: 20
Age Group: 18 Years and older (Adult, Senior)
Gender: All
Study Type: Interventional
Study Design Allocation: Allocation: Non-Randomized|Intervention Model: Parallel Assignment|Masking: Open Label|Primary Purpose: Treatment
Study ID Numbers: NVCI05-14
Study First Received: January 6, 2006
Last Updated: March 15, 2012
Estimated Primary Completion Date: September 2006
Primary Outcome Measures:
To determine the Maximum tolerated dose (MTD) and Dose Limiting toxicities (DLTs) of a combination of Pemetrexed and PTK787/ZK222584 (Cohort 1) and a combination of Pemetrexed with Cisplatin and PTK787/ZK222584 (Cohort 2) in patients|To determine the preliminary evidence of safety of the above combinations in patients with non-small cell lung cancers and/or mesotheliomas (in the expansion cohorts)|To determine the pharmacokinetics of PTK787/ZK222584 in combination with Pemetrexed and Cisplatin|To determine the pharmacokinetics of Pemetrexed in combination with PTK787/ZK 222584|To determine the effect of therapy with the combination on plasma levels of VEGF A, B, C and D and on plasma levels of soluble VEGF-R2.|To determine the relationship between PTK787/ZK 222584 and Pemetrexed pharmacokinetics and plasma levels of VEGF A, B, C, D, soluble VEGF-R2, and exploratory chemotherapeutic response biomarkers.|To determine the baseline expression of VEGF-R2 by immunohistochemistry in patients where paraffin blocks/slides are available.
Sponsors and Collaborators:
Nevada Cancer Institute
Website Link: https://ClinicalTrials.gov/show/NCT00281125
