Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer

January 28, 2013 updated by: Laura W. Goff, MD, Vanderbilt-Ingram Cancer Center

Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis

RATIONALE: Studying samples of blood and urine in the laboratory from patients with cancer receiving epidermal growth factor receptor inhibitors may help doctors understand the effect of epidermal growth factor receptor inhibitors on magnesium levels in the body.

PURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.

Study Overview

Status

Terminated

Conditions

Solid Tumor

Intervention / Treatment

Other: laboratory biomarker analysis

Detailed Description

OBJECTIVES:

Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with cancer.

OUTLINE: This is a pilot study.

Patients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks during treatment.

After finishing treatment, patients are followed periodically for up to 10 weeks.

Study Type

Observational

Enrollment (Actual)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Individuals with the diagnosis of a malignancy for which they are considering therapy with an inhibitor of the EGFR pathway, have received an inhibitor of the EGFR pathway prior to study start, have no severe underlying renal dysfunction as defined as estimated GFR<60 by MDRD equation and must be ≥ 18 years of age.

Description

Inclusion Criteria:

Diagnosis of malignancy
- Planning to receive therapy with an inhibitor of the EGFR pathway (either on or off a clinical trial and may be monotherapy or combined with other therapies)
Normal serum magnesium level

Exclusion Criteria:

Glomerular filtration rate ≥ 60 mL/min
No severe underlying renal dysfunction
Normal serum potassium and calcium level
No history of primary or secondary hyperparathyroidism

PRIOR CONCURRENT THERAPY:

No prior EGFR pathway inhibitor

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Case-Only
Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Effects of EGFR inhibitors on magnesium homeostasis Time Frame: 8 weeks	8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

National Institutes of Health (NIH)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (Actual)

March 1, 2008

Study Completion (Actual)

February 1, 2009

Study Registration Dates

First Submitted

May 9, 2009

First Submitted That Met QC Criteria