Clinical Trials for Mesothelioma Patients: Pemetrexed, Cisplatin, and Vitamin B12 Study Outcome
Read about the outcome measures in this clinical trial being conducted to study the effects of Pemetrexed, Cisplatin, and Vitamin B12 for patients who have been diagnosed with mesothelioma. Please note: this information is provided by Weitz & Luxenberg for informational purposes only. At this time, this study is only being conducted in Lille, France.
Primary Outcome Measures:
• Individual dosage-adapted protocol [ Designated as safety issue: No ]Secondary Outcome Measures:
• Relationship between pharmacokinetic and pharmacodynamic parameters [ Designated as safety issue: No ]
• Pharmacokinetics [ Designated as safety issue: No ]
• Pharmacogenetic variations (MTHFR, TS, GSTpi, ERCC1, XPD) [ Designated as safety issue: No ]
Recruitment Information:
Recruitment Status: Recruiting
Enrollment: 50
Study Start Date: June 2007
Primary Objectives:
• Define an individually adapted (by dosage) protocol of pemetrexed disodium, cisplatin, and vitamin B12 in patients with unresectable pleural mesothelioma.Secondary Objectives:
• Determine the relationship between pharmacokinetic and pharmacodynamic parameters (hematologic and nonhematologic).
• Analyze the inter-individual pharmacokinetic variations and the influence of the covariables on the pharmacokinetics of pemetrexed disodium.
• Analyze the impact of pharmacogenetic (MTHFR, TS, GSTpi, ERCC1, XPD) variations on the toxicity of pemetrexed disodium.
• Validate a strategy of adapting dosage.
Courtesy of ClinicalTrials.gov.
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