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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00898027
• Other study ID #: VICC GI 0615
• Secondary ID: VU-VICC-GI-0615V
• Status: Terminated
• Phase: N/A
• First received: May 9, 2009
• Last updated: January 28, 2013
• Start date: May 2006
• Est. completion date: February 2009

Study information

• Verified date: January 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: February 2009
• Est. primary completion date: March 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Other:
• laboratory biomarker analysis
laboratory biomarker analysis

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects of EGFR inhibitors on magnesium homeostasis		8 weeks	No