A Phase II Double Blind Randomized Trial Comparing Standard Dosing Based on Body Surface Area Versus Dosing Based on Personalized Lean Body Mass in Patients With Stage IIIB or IV Non-Small Cell Lung Cancer Receiving First Line Cisplatin Based Chemotherapy
Retrospective findings of NSCLC patients treated with a cisplatin based chemotherapy regimen
show that although all were given cisplatin at the standard rate of 75 mg/m2 according to
lean body mass, when this was expressed in relation to individual lean body mass, there was
a high degree of variation. Incidence of dose limiting toxicity was 41% in patients whose
dose was within + 25% of the median value. However, sarcopenic patients received on average
a 35% higher dose and 80% of these patients experienced severe toxicity requiring dose
reduction or termination of therapy, a clinically unacceptable level. The relatively
muscular subset of patients with higher lean body mass had a reduced level of severe
toxicity compared to those at the median dose. These findings have led to the design of a
study with the goal of reducing high levels of toxicity in sarcopenic patients. If the
expected level of dose limiting toxicity in sarcopenic patients is 80% based on the standard
method of dosing, this could be expected to be reduced to the median value of 41% dose
limiting toxicity by the administration of cisplatin scaled to individual lean body mass.
Hypothesis: Levels of severe toxicity in sarcopenic patients may be reduced to clinically
acceptable levels by cisplatin dosing scaled to 3.1 mg/kg lean body mass compared with
standard dosing of 75 mg/m2 based on body surface area.
Interventional
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Dose limiting toxicity rates
Assessed weekly until patients come off study (an expected average of 9 weeks)
Yes
Michael B Sawyer, MD
Principal Investigator
Medical Oncologist, Cross Cancer Institute
Canada: Health Canada
Sawyer - Lung - CCI
NCT01624051
July 2012
September 2015
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