Clinical Trials for Mesothelioma Patients: Valproate and Doxorubicin Outcomes Measures

Read about the outcomes measures for a current clinical trial being conducted to study Valproate and Doxorubicin in patients who have been diagnosed with mesothelioma. At this time, the study is only being conducted in Belgium and France. Please note: this information is provided by Weitz & Luxenberg for informational purposes only.

Primary Outcome Measures:
Response rate [ Time Frame: Every 3 courses ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
Survival [ Time Frame: Survival will be dated from the day of registration until death or last follow up ] [ Designated as safety issue: No ]

Toxicity [ Time Frame: After each course of chemotherapy and at the end of treatment ] [ Designated as safety issue: No ]

Recruitment Information:
Recruitment Status: Recruiting
Enrollment: 41
Study Start Date: July 2006
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)

Arms and Assigned Interventions:
A: Experimental Continuous oral administration of valproate plus every 3 weeks, intravenous administration of doxorubicin

Drug: Valproate plus doxorubicin

Valproate 20-30 mg/kg orally (in order to obtain serum concentration between 50-100 mcg/ml) Doxorubicin 60 mg/m² intravenously every 3 weeks

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