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

Overview

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.

Full Title of Study: “Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: March 2008

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.

Interventions

  • Other: laboratory biomarker analysis
    • laboratory biomarker analysis

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt-Ingram Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Laura W. Goff, MD, Assistant Professor of Medicine; Associate Director, Hematology/Oncology – Vanderbilt-Ingram Cancer Center
  • Overall Official(s)
    • Laura Goff, MD, Principal Investigator, Vanderbilt-Ingram Cancer Center

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