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

NCT ID: NCT00898027

Last Updated: 2013-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

10 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-05-31

Study Completion Date

2009-02-28

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Solid Tumor

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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laboratory biomarker analysis

laboratory biomarker analysis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

Vanderbilt-Ingram Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Laura W. Goff, MD

Assistant Professor of Medicine; Associate Director, Hematology/Oncology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Laura Goff, MD

Role: PRINCIPAL_INVESTIGATOR

Vanderbilt-Ingram Cancer Center

Other Identifiers

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VU-VICC-GI-0615

Identifier Type: -

Identifier Source: secondary_id

VU-VICC-IRB-060364

Identifier Type: -

Identifier Source: secondary_id

VICC GI 0615

Identifier Type: -

Identifier Source: org_study_id

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