The Role of the EKG in Anticancer Drug Development

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01462383
First received: October 27, 2011
Last updated: December 9, 2011
Last verified: December 2011
  Purpose

Primary Objective:

-Evaluate incidence of cardiac complications in Phase I patients.

Secondary Objective:

-To identify variables (i.e. number of electrocardiograms (EKG) performed) that lead to the detection of cardiac events.


Condition
Advanced Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: The Role of the EKG in Anticancer Phase I Drug Development

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Incidence of Cardiac Complications in Participants on Phase I Protocols [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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.


Enrollment: 525
Study Start Date: January 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Detailed Description:

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 their detection.

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 multivariable analyses.

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 maximum.

This study will be conducted at the MD Anderson Cancer Center in Houston, Texas.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

The study population will consist of patients in the Department of Investigational Cancer Therapeutics diagnosed with a malignancy and registered at MDACC for medical care on IRB approved sponsored protocols active between January 1, 2006 and December 31, 2009.

Criteria

Inclusion Criteria:

  • All types of advanced cancer

Exclusion Criteria:

  • N/A
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01462383

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Aung Naing, MD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01462383     History of Changes
Other Study ID Numbers: DR11-0061
Study First Received: October 27, 2011
Last Updated: December 9, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Advanced Cancer
Malignancy
Cardiac complications
Electrocardiograms
ECG
Chart Review
Data Review
Data Analysis
Phase I
Clinical Research Study

ClinicalTrials.gov processed this record on September 30, 2014