Ignite Creation Date:
2025-12-25 @ 5:19 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT00898027
Status:
TERMINATED
Last Update Posted:
2013-01-29
First Post:
2009-05-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'slow accrual', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-28', 'studyFirstSubmitDate': '2009-05-09', 'studyFirstSubmitQcDate': '2009-05-09', 'lastUpdatePostDateStruct': {'date': '2013-01-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of EGFR inhibitors on magnesium homeostasis', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': '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.\n\nPURPOSE: This laboratory study is looking at the effect of epidermal growth factor receptor inhibitors on magnesium homeostasis in patients with cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effects of EGFR inhibitors on magnesium homeostasis in patients with cancer.\n\nOUTLINE: This is a pilot study.\n\nPatients undergo blood and urine sample collection at baseline and at 2, 4, and 8 weeks during treatment.\n\nAfter finishing treatment, patients are followed periodically for up to 10 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of malignancy\n\n * 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)\n* Normal serum magnesium level\n\nExclusion Criteria:\n\n* Glomerular filtration rate ≥ 60 mL/min\n* No severe underlying renal dysfunction\n* Normal serum potassium and calcium level\n* No history of primary or secondary hyperparathyroidism\n\nPRIOR CONCURRENT THERAPY:\n\n* No prior EGFR pathway inhibitor'}, 'identificationModule': {'nctId': 'NCT00898027', 'briefTitle': 'Effect of Epidermal Growth Factor Receptor Inhibitors on Magnesium Homeostasis in Patients With Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on Magnesium Homeostasis', 'orgStudyIdInfo': {'id': 'VICC GI 0615'}, 'secondaryIdInfos': [{'id': 'VU-VICC-GI-0615'}, {'id': 'VU-VICC-IRB-060364'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'laboratory biomarker analysis'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Laura Goff, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt-Ingram Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt-Ingram Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine; Associate Director, Hematology/Oncology', 'investigatorFullName': 'Laura W. Goff, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}