Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2026-01-27 @ 1:47 PM
Study NCT ID:
NCT00570232
Status:
COMPLETED
Last Update Posted:
2015-05-21
First Post:
2007-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006258', 'term': 'Head and Neck Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'erosenthal@uabmc.edu', 'phone': '2059349713', 'title': 'Eben Rosenthal,MD', 'organization': 'University of Alabama at Birmingham'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Tarceva', 'description': 'All patients will be prescribed Tarceva 150mg daily\n\nErlotinib: 150 mg per day by mouth for 12 months', 'otherNumAtRisk': 31, 'otherNumAffected': 31, 'seriousNumAtRisk': 31, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'acniform rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 26}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 22}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 22}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperglycemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 21}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 13}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dry skin', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypoalbuminemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 7}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'weight loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'decreased platelet count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 5}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hyperkalemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypercalcemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'constipation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hyponatremia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hirsutism', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspepsia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'depression', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'dyspnea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 3}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'reflux', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypomagnesemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'alopecia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'hypophosphatemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numAffected': 2}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'pneumonia leading to respiratory failure', 'notes': 'Pt hospitalized for respiratory failure and pneumonia felt releated to disease recurrence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'bleeding from throat', 'notes': 'Pt hospitalized for throat bleeding felt related to disease progress', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'stridor', 'notes': 'Pt hospitalized for stridor and trach debulking, felt unrelated to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': "Bell's Palsy", 'notes': "Pt hospitalized and diagnosed with Bell's Palsy", 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'pneumonia', 'notes': 'Pt hospitalized for pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'cardiac stents placed', 'notes': 'Pt had cardiac stents placed; event deemed unrelated to protocol therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'H pylori infection', 'notes': 'Pt hospitalized for nausea and vomiting felt related to inadequate PEG and H pylori infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'myocardial infarction', 'notes': 'Pt hospitalized for MI felt possibly related to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'ARDS', 'notes': 'Pt hospitalized for septic shock and ARDS related to pneumonia; unrelated to study drug', 'stats': [{'groupId': 'EG000', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'All patients will be prescribed Tarceva 150mg daily\n\nErlotinib: 150 mg per day by mouth for 12 months'}], 'classes': [{'title': 'rash', 'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000'}]}]}, {'title': 'diarrhea', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'fatigue', 'categories': [{'measurements': [{'value': '22', 'groupId': 'OG000'}]}]}, {'title': 'nausea', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'vomiting', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'headache', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 - 24 months', 'description': 'Number of participants who had the most frequently observed undesirable effects after exposure to study drug', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With Disease Free Status at 12 Months and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'All patients will be prescribed Tarceva 150mg daily\n\nErlotinib: 150 mg per day by mouth for 12 months'}], 'classes': [{'title': 'disease free rate at 12 months', 'categories': [{'measurements': [{'value': '54', 'groupId': 'OG000'}]}]}, {'title': 'disease free rate at 24 months', 'categories': [{'measurements': [{'value': '45', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 - 24 months', 'description': 'Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Tarceva', 'description': 'All patients will be prescribed Tarceva 150mg daily\n\nErlotinib: 150 mg per day by mouth for 12 months'}], 'classes': [{'title': 'survival rate at 12 months', 'categories': [{'measurements': [{'value': '61', 'groupId': 'OG000'}]}]}, {'title': 'survival rate at 24 months', 'categories': [{'measurements': [{'value': '56', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '12 - 24 months', 'description': 'Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Tarceva', 'description': 'All patients will be prescribed Tarceva 150mg daily\n\nErlotinib: 150 mg per day by mouth for 12 months'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '23'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '10'}]}, {'type': 'discontinued due to medical condition', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'discontinued due to recurrence', 'reasons': [{'groupId': 'FG000', 'numSubjects': '8'}]}, {'type': 'discontinued due to noncompliance', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '31', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Tarceva', 'description': 'All patients will be prescribed Tarceva 150mg daily\n\nErlotinib: 150 mg per day by mouth for 12 months'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '21', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG performance status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'ECOG PS 0 Fully active,able to carry on all predisease performance without restriction\n\n1. Restricted in physically strenuous activity but ambulatory \\& able to carry out work of a light or sedentary nature, e.g., light house work, office work\n2. Ambulatory \\& capable of all selfcare but unable to carry out any work activities. Up \\& about more than 50% of waking hours\n3. Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours\n4. Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair\n5. Dead The ECOG PS is in the public domain.', 'unitOfMeasure': 'participants'}, {'title': 'Tumor Stage at Study Start - Primary Tumor Stage (T)', 'classes': [{'title': 'T1', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'T2', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'T3', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'not specified', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Classification of Malignant Tumors based on the American Joint Committee on Cancer (AJCC) staging criteria. T indicates tumor size, extent, or penetration (depth) of the tumor. T1 is the smallest/least advanced,while T4 is the largest/most advanced.', 'unitOfMeasure': 'participants'}, {'title': 'Tumor Stage at Study Start - Regional Metastasis (N)', 'classes': [{'title': 'N0', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}]}]}, {'title': 'N1', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'N2', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'N3', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'not specified', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Classification of Malignant Tumors based on the American Joint Committee on Cancer (AJCC) staging criteria. N indicates the number of lymph nodes with cancer or the location of the cancer-involved lymph nodes.\n\nN0 = no regional lymph node metastasis\n\nN1 = a single ipsilateral lymph node \\<3 cm in greatest dimension\n\nN2 = a single ipsilateral lymph nodes 3-6 cm in size OR multiple ipsilateral, bilateral, or contralateral lymph nodes \\<6 cm in greatest dimension\n\nN3 = a lymph node \\>6 cm in greatest dimension', 'unitOfMeasure': 'participants'}, {'title': 'Extent of recurrence', 'classes': [{'title': 'Local', 'categories': [{'measurements': [{'value': '21', 'groupId': 'BG000'}]}]}, {'title': 'Regional', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': 'Locoregional', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Tumor subsite', 'classes': [{'title': 'oral cavity', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'larynx', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'hypopharynx', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'oropharynx', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'location of primary tumor', 'unitOfMeasure': 'participants'}, {'title': 'Procedure details', 'classes': [{'title': 'Coincident tracheostomy', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Coincident PEG', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who received coincident placement of tracheostomy or PEG tube during salvage surgery prior to enrollment', 'unitOfMeasure': 'participants'}, {'title': 'Flap reconstruction', 'classes': [{'title': 'Yes', 'categories': [{'measurements': [{'value': '27', 'groupId': 'BG000'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who received flap reconstruction during salvage surgery prior to enrollment', 'unitOfMeasure': 'participants'}, {'title': 'Neck dissection', 'classes': [{'title': 'Unilateral', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}, {'title': 'Bilateral', 'categories': [{'measurements': [{'value': '12', 'groupId': 'BG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of participants who received a neck dissection (either unilateral or bilateral) during salvage surgery prior to enrollment', 'unitOfMeasure': 'participants'}, {'title': 'Histological tumor grade', 'classes': [{'title': 'Well differentiated', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Moderately differentiated', 'categories': [{'measurements': [{'value': '14', 'groupId': 'BG000'}]}]}, {'title': 'Poorly differentiated', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Not specified', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Histological features', 'classes': [{'title': 'Perineural invasion present', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}, {'title': 'Lymphovascular invasion present', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Positive lymph nodes', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'None', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 31}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-04', 'studyFirstSubmitDate': '2007-12-06', 'resultsFirstSubmitDate': '2015-03-24', 'studyFirstSubmitQcDate': '2007-12-07', 'lastUpdatePostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-05-04', 'studyFirstPostDateStruct': {'date': '2007-12-10', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-05-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Demonstrating the Safety and Tolerability of Long Term Erlotinib Treatment', 'timeFrame': '12 - 24 months', 'description': 'Number of participants who had the most frequently observed undesirable effects after exposure to study drug'}, {'measure': 'Percentage of Participants With Disease Free Status at 12 Months and 24 Months', 'timeFrame': '12 - 24 months', 'description': 'Percentage of participants who were disease free at 12 months (12 months after initiation of study drug treatment) and 24 months (12 months after completion of study drug treatment)'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Demonstrating Survival at 12 Months and 24 Months.', 'timeFrame': '12 - 24 months', 'description': 'Percentage of participants who were still alive at 12 months following completion of study drug therapy and at 24 months following completion of study drug therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Resectable, recurrent head and neck cancer'], 'conditions': ['Head and Neck Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether erlotinib will be effective in controlling cancer that has returned after treatment with salvage surgery and radiation. This study will also determine what effects, good and/or bad, this drug has on the participants.', 'detailedDescription': 'An investigator-initiated Phase II clinical trial of the safety and tolerability of erlotinib as an adjuvant therapy after definitive therapy via salvage surgery in head and neck cancer patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Pathologically confirmed diagnosis of recurrent or second primary squamous cell carcinoma\n2. Recurrence or second primary of the oral cavity, oropharynx, hypopharynx, or larynx. Recurrent neck metastasis with unknown primary is allowed\n3. Prior radiation therapy for head and neck cancer\n4. Disease must be considered surgically resectable or candidate for curative reirradiation\n5. Adequate diagnostic workup\n6. Zubrod Performance Status 0-2\n7. Life expectancy 12 weeks\n8. Age 19, 9. Adequate laboratory data.\n\nExclusion Criteria:\n\n1. Prior invasive cancers other than head and neck cancer unless disease free for a minimum of 3 years. (Prior non-melanomatous skin cancer and previous carcinoma in situ are permissible)\n2. Patients who are pregnant or lactating\n3. Psychological condition that renders the patient unable to understand the informed consent\n4. Any situation or condition that will interfere with adherence to study activities.'}, 'identificationModule': {'nctId': 'NCT00570232', 'acronym': 'UAB0718', 'briefTitle': 'UAB 0718 - Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'Phase II Trial to Assess Target Oral Therapy as Adjuvant Chemoprevention in High-Risk Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'F070824015'}, 'secondaryIdInfos': [{'id': 'UAB 0718', 'type': 'OTHER', 'domain': 'UAB ComprehensiveCancerCenter ClinicalTrialsReviewCommittee'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Tarceva', 'description': 'All patients will be prescribed erlotinib 150mg daily', 'interventionNames': ['Drug: Erlotinib']}], 'interventions': [{'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': '150 mg per day by mouth for 12 months', 'armGroupLabels': ['Tarceva']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}], 'overallOfficials': [{'name': 'Eben Rosenthal, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Alabama at Birmingham'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'OSI Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Surgery', 'investigatorFullName': 'Eben Rosenthal', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}