The Role of the EKG in Anticancer Phase I Drug Development
The research plan includes a retrospective review of the chart of past UT MD Anderson Cancer
Center (MDACC) patients and the experience in treating them.
All studies analyzed will be Phase I clinical trials.
Analysis is designed to collect information on the number of and timeframe within which ECGs
are performed on these trials. Data on adverse events and serious adverse events, dose
modifications based on ECG changes, attribution to drug, incidence and types of ECG changes
specifically QTC prolongation as well as their influence on study procedures like dose
limiting toxicities (DLTs) in dose escalation phase of the studies.
Study conducted using clinical records of patients treated on Phase I protocols in the MDACC
Department of Investigational Cancer Therapeutics. The demographic data to be collected
from patients whose charts will be analyzed will include variables such as age, gender,
primary cancer, stage of the disease, performance status, treatment characteristics (i.e.,
number and type of prior therapies), disease status, adverse events, laboratory data (i.e.,
complete blood count/differential/platelets, tumor markers), and treatment outcomes.
The analysis will allow identification and descriptive analysis of the occurrence of cardiac
events in the phase I population and will help define the role of protocol required EKGs in
HIPAA privacy and confidentiality guidelines will be followed. The database will be secured
in the Department server. A Data coordinator has been recruited to undertake this project.
The information derived from these observations will help the investigators formulate
research questions and projects to develop future prospective studies.
The statistical analysis will be performed in a descriptive fashion with paired and
The analyses will be reported using summary tables, figures, and data listings. Continuous
variables will be summarized using the mean, standard deviation, median, minimum, and
This study will be conducted at the MD Anderson Cancer Center in Houston, Texas.
Observational Model: Cohort, Time Perspective: Retrospective
Incidence of Cardiac Complications in Participants on Phase I Protocols
Data review of studies, active between January 1, 2006 and December 31, 2009, who included ECGs in their safety evaluations. Use of identification and descriptive analysis of cardiac events occurrence in the phase I population to define role of protocol required EKGs in their detection. Statistical analysis performed in a descriptive fashion with paired and multivariable analyses.
Aung Naing, MD
UT MD Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|