Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2026-01-13 @ 11:16 PM
Study NCT ID:
NCT00483457
Status:
COMPLETED
Last Update Posted:
2012-09-03
First Post:
2007-06-06
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D007150', 'term': 'Immunohistochemistry'}, {'id': 'D001706', 'term': 'Biopsy'}], 'ancestors': [{'id': 'D006651', 'term': 'Histocytochemistry'}, {'id': 'D003584', 'term': 'Cytological Techniques'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D006652', 'term': 'Histological Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007158', 'term': 'Immunologic Techniques'}, {'id': 'D003581', 'term': 'Cytodiagnosis'}, {'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D003949', 'term': 'Diagnostic Techniques, Surgical'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-31', 'studyFirstSubmitDate': '2007-06-06', 'studyFirstSubmitQcDate': '2007-06-06', 'lastUpdatePostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of EGFR inhibitors on the EGFR pathway in the skin prior to and after receiving EGFR inhibitors', 'timeFrame': 'baseline and at 6 weeks'}], 'secondaryOutcomes': [{'measure': 'Comparison of the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin', 'timeFrame': 'at 6 weeks'}, {'measure': 'Comparison of changes in the EGFR pathway with grade of rash', 'timeFrame': 'at 6 weeks'}, {'measure': 'Comparison of changes in EGFR pathway effectors in the skin with serum TGFα levels as assessed by immunohistochemistry and western blot', 'timeFrame': 'at 6 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['unspecified adult solid tumor, protocol specific'], 'conditions': ['Solid Tumor']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Studying samples of tissue and blood in the laboratory from patients with cancer receiving epidermal growth factor receptor (EGFR) inhibitors may help doctors understand the effects of EGFR inhibitor therapy in the skin.\n\nPURPOSE: This laboratory study is looking at the effects of EGFR inhibitors in the skin of cancer patients.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effects of EGFR inhibitors on the EGFR pathway in the skin of cancer patients prior to and after receiving EGFR inhibitors (i.e., tyrosine kinase inhibitors and monoclonal antibodies).\n* Compare the effects of EGFR tyrosine kinase inhibitors vs monoclonal antibodies on the EGFR pathway in the skin of these patients.\n* Compare changes in the EGFR pathway with grade of rash in these patients.\n* Compare changes in EGFR pathway effectors in the skin with serum TGFα levels in these patients.\n\nOUTLINE: This is a pilot study.\n\nPatients undergo skin punch biopsies and blood sample collection at baseline, within 1 week of developing skin rash, and 6 weeks after beginning treatment. Samples are analyzed by immunohistochemistry and western blot for phosphorylated MAP kinase, AKT, and EGF levels and TGFα levels. Patients also complete diagrams to indicate locations of the rash once weekly during the first 6 weeks of treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients must be ≥ 18 years of age, have the diagnosis of a malignancy for which they are considering therapy with an inhibitor of the EGFR pathway, have no severe underlying skin disorder, must not have a bleeding diathesis that would preclude safe biopsy and patients on coumadin must not have an INR \\> 3.0 at time of biopsy.', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Diagnosis of a malignancy for which therapy on or off a clinical trial with an inhibitor of the EGFR pathway is under consideration\n\n * The therapy under consideration may be monotherapy or combined with other therapies as long as other therapies do not typically cause a rash\n\nPATIENT CHARACTERISTICS:\n\n* INR ≤ 3.0 (for patients receiving concurrent warfarin)\n* No severe underlying skin disorder (e.g., toxic epidermal necrolysis or severe dermatitis) that would preclude study treatment\n* No bleeding diatheses that would preclude safe biopsy\n* No allergy to lidocaine or similar local anesthetics\n\nPRIOR CONCURRENT THERAPY:\n\n* See Disease Characteristics'}, 'identificationModule': {'nctId': 'NCT00483457', 'briefTitle': 'Effects of Epidermal Growth Factor Receptor Inhibitor Therapy in the Skin of Cancer Patients', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt-Ingram Cancer Center'}, 'officialTitle': 'Pilot Study of the Effects of Epidermal Growth Factor Receptor (EGFR) Inhibitors on the EGFR in Skin Lesions', 'orgStudyIdInfo': {'id': 'VICC GI 0561'}, 'secondaryIdInfos': [{'id': 'VU-VICC-GI-0561'}, {'id': 'VU-VICC-IRB-051020'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'enzyme inhibitor therapy', 'type': 'DRUG', 'description': 'enzyme inhibitor therapy'}, {'name': 'protein expression analysis', 'type': 'GENETIC', 'description': 'protein expression analysis'}, {'name': 'immunohistochemistry staining method', 'type': 'OTHER', 'description': 'immunohistochemistry staining method'}, {'name': 'laboratory biomarker analysis', 'type': 'OTHER', 'description': 'laboratory biomarker analysis'}, {'name': 'biopsy', 'type': 'PROCEDURE', 'description': 'biopsy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt-Ingram Cancer Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], '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'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Medicine; Associate Director, Hematology/Oncology Fellowship Program; Medical Oncologist', 'investigatorFullName': 'Laura W. Goff, MD', 'investigatorAffiliation': 'Vanderbilt-Ingram Cancer Center'}}}}