Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2025-12-26 @ 2:58 AM
Study NCT ID:
NCT00970502
Status:
COMPLETED
Last Update Posted:
2017-04-10
First Post:
2009-09-01
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D007822', 'term': 'Laryngeal Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D010255', 'term': 'Paranasal Sinus Neoplasms'}], 'ancestors': [{'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D007818', 'term': 'Laryngeal Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012142', 'term': 'Respiratory Tract Neoplasms'}, {'id': 'D009669', 'term': 'Nose Neoplasms'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D010254', 'term': 'Paranasal Sinus Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}, {'id': 'D000068579', 'term': 'Celecoxib'}], 'ancestors': [{'id': 'D011799', 'term': 'Quinazolines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D000096926', 'term': 'Benzenesulfonamides'}, {'id': 'D013449', 'term': 'Sulfonamides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D013450', 'term': 'Sulfones'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D011720', 'term': 'Pyrazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'johnnykaomd@gmail.com', 'phone': '813-661-6442', 'title': 'Dr. Johnny Kao', 'organization': 'Florida Radiation Oncology Group'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Erlotinib + Celecoxib', 'description': 'erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression', 'otherNumAtRisk': 14, 'otherNumAffected': 14, 'seriousNumAtRisk': 14, 'seriousNumAffected': 14}], 'otherEvents': [{'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 10}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 11}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Xerostomia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'abnormal white blood cell count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 5}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'abnormal hemoglobin count', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 12}], 'organSystem': 'Blood and lymphatic system disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acneiform rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 12}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic (Na, K, Ca)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 4}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Elevated Liver Function Tests', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Hepatobiliary disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rectal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Conjuncitivitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'pharyngocutaneous fistula', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'folliculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'rectal bleeding', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'bone necrosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'trismus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 3}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 2}], 'organSystem': 'General disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Acneiform Rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Metabolic (Na, K, Ca)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 14, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Celecoxib 200mg', 'description': 'Dose Level 1: Patients administered 150mg Erlotinib daily and 200mg Celecoxib twice daily'}, {'id': 'OG001', 'title': 'Celecoxib 400mg', 'description': 'Dose Level 2: Patients administered 150mg Erlotinib daily and 400mg Celecoxib twice daily'}, {'id': 'OG002', 'title': 'Celecoxib 600mg', 'description': 'Dose Level 3: Patients administered 150mg Erlotinib daily and 600mg Celecoxib twice daily'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}, {'value': '2', 'groupId': 'OG002'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '30 DAYS', 'description': 'Number of participants with acute and late toxicity', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Erlotinib and celecoxib were administered orally'}, {'type': 'SECONDARY', 'title': 'Clinical Response', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Celecoxib', 'description': 'erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression'}], 'classes': [{'title': 'Complete Response(CR)', 'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000'}]}]}, {'title': 'Pathologic partial response (pPR)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Progressive disease (PD)', 'categories': [{'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'No evidence of disease (NED)', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '20 months', 'description': 'Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Locoregional Progression', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Celecoxib', 'description': 'erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression'}], 'classes': [{'title': 'free of disease', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'isolated locoregional progression', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'isolated distant progression', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'both locoregional and distant progression', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'no evidence of disease, died of comorbid illness', 'categories': [{'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '20 months', 'description': 'Patients with locoregional and/or distant progression', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Erlotinib + Celecoxib', 'description': 'Recommended dose of celecoxib was 400mg'}], 'classes': [{'title': 'locoregional control', 'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}]}]}, {'title': 'progress-free survival', 'categories': [{'measurements': [{'value': '37', 'groupId': 'OG000'}]}]}, {'title': 'overall survival rates', 'categories': [{'measurements': [{'value': '55', 'groupId': 'OG000'}]}]}, {'title': 'long term toxicity', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 year', 'description': 'At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Erlotinib + Celecoxib', 'description': 'erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'All patients were evaluated by head and neck surgery, medical oncology, and radiation oncology before trial entry. Patients were enrolled at least 6 months after they had completed prior radiation. Patients were enrolled between March 2007 and December 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Erlotinib + Celecoxib', 'description': 'erlotinib + celecoxib: In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '43', 'upperLimit': '93'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '10', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'ECOG Performance Status', 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}, {'title': '1', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}, {'title': '2', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'The Eastern Cooperative Oncology Group (ECOG) 0 - Fully active, able to carry on all pre-disease performance without restriction\n\n1 - Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature 2- Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours', 'unitOfMeasure': 'participants'}, {'title': 'Tobacco use, pack-years', 'classes': [{'title': 'None to minimal', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': '<20', 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}, {'title': '20-40', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': '>40', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Recurrent vs secondary primary', 'classes': [{'title': 'Primary recurrence', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}]}]}, {'title': 'Second or later recurrence', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Second primary cancer', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Histology', 'classes': [{'title': 'Squamous cell carcinoma', 'categories': [{'measurements': [{'value': '13', 'groupId': 'BG000'}]}]}, {'title': 'Adenoid cystic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary Site', 'classes': [{'title': 'Sinonasal', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Ear/facial skin', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}, {'title': 'Oropharynx', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'Oral cavity', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}, {'title': 'Hypopharynx', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'Larynx', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Primary tumor classification', 'classes': [{'title': 'Tx-T3', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'T4', 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'T4 --\\> Tumor of any size with direct extension to chest wall or skin Tx - T3 --\\> any tumor not classified as T4', 'unitOfMeasure': 'participants'}, {'title': 'Lymph node status', 'classes': [{'title': 'N0', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}]}]}, {'title': 'N1', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'N0 - tumor cells absent from regional lymph nodes N1 - regional lymph node metastasis present; (at some sites; tumor spread to closest or small number of regional lymph nodes)', 'unitOfMeasure': 'participants'}], 'populationDescription': '15 subjects consented, one withdrew before receiving study treatment and was excluded from analysis'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-24', 'studyFirstSubmitDate': '2009-09-01', 'resultsFirstSubmitDate': '2016-12-23', 'studyFirstSubmitQcDate': '2009-09-01', 'lastUpdatePostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2017-02-24', 'studyFirstPostDateStruct': {'date': '2009-09-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2017-04-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': '30 DAYS', 'description': 'Number of participants with acute and late toxicity'}], 'secondaryOutcomes': [{'measure': 'Clinical Response', 'timeFrame': '20 months', 'description': 'Response to Concurrent Erlotinib, Celecoxib, and Reirradiation according to Response Evaluation Criteria in Solid Tumors - Complete Response (CR): Disappearance of all target lesions Partial Response (PR): At least a 30% decrease in the sum of the LD of target lesions, taking as reference the baseline sum LD Progressive Disease (PD): At least a 20% increase in the sum of the LD of target lesions, taking as reference the smallest sum LD recorded since the treatment started or the appearance of one or more new lesions'}, {'measure': 'Locoregional Progression', 'timeFrame': '20 months', 'description': 'Patients with locoregional and/or distant progression'}, {'measure': 'Locoregional Control, Progression-free Survival, Overall Survival and Late Toxicity', 'timeFrame': '1 year', 'description': 'At a median follow-up of 11 months, the 1 year locoregional control, progression-free survival, and overall survival rates.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['celecoxib', 'erlotinib', 'epidermal growth factor receptor', 'intensity-modulated radiotherapy', 'cyclooxygenase-2', 'reirradiation'], 'conditions': ['Cancer of the Pharynx', 'Cancer of the Larynx', 'Cancer of the Neck', 'Paranasal Sinus Neoplasms', 'Cancer of the Head']}, 'referencesModule': {'references': [{'pmid': '16213104', 'type': 'BACKGROUND', 'citation': 'Salama JK, Vokes EE, Chmura SJ, Milano MT, Kao J, Stenson KM, Witt ME, Haraf DJ. Long-term outcome of concurrent chemotherapy and reirradiation for recurrent and second primary head-and-neck squamous cell carcinoma. Int J Radiat Oncol Biol Phys. 2006 Feb 1;64(2):382-91. doi: 10.1016/j.ijrobp.2005.07.005. Epub 2005 Oct 5.'}, {'pmid': '12633577', 'type': 'BACKGROUND', 'citation': 'Kao J, Garofalo MC, Milano MT, Chmura SJ, Citron JR, Haraf DJ. Reirradiation of recurrent and second primary head and neck malignancies: a comprehensive review. Cancer Treat Rev. 2003 Feb;29(1):21-30. doi: 10.1016/s0305-7372(02)00096-8.'}, {'type': 'BACKGROUND', 'citation': 'J. Kao, S. H. Packer, M. Teng, V. Gupta, K. Misiukiewicz, E. M. Genden; Mount Sinai School of Medicine, New York, NY, J Clin Oncol 28:15s, 2010 (suppl; abstr 5561).'}, {'pmid': '21246519', 'type': 'RESULT', 'citation': 'Kao J, Genden EM, Chen CT, Rivera M, Tong CC, Misiukiewicz K, Gupta V, Gurudutt V, Teng M, Packer SH. Phase 1 trial of concurrent erlotinib, celecoxib, and reirradiation for recurrent head and neck cancer. Cancer. 2011 Jul 15;117(14):3173-81. doi: 10.1002/cncr.25786. Epub 2011 Jan 18.'}]}, 'descriptionModule': {'briefSummary': 'There is no optimal treatment for patients with recurrent head and neck cancer after previous radiation. Chemotherapy alone is not curative and patients survive an average of only 6 to 10 months. Surgery is not always possible and often cannot remove every cancerous cell. On the other hand, reirradiation with chemotherapy cures approximately 25 to 30% of patients but has significant toxicity with as many as 15 to 20% suffering from life-threatening or fatal complications. Therefore, less toxic and more effective reirradiation regimens are urgently needed. There are extensive data from animal studies and preliminary human studies showing that blocking epidermal growth factor receptor (EGFR) and COX-2 enhances radiation effect and is more effective than either treatment alone. Erlotinib is a FDA approved oral inhibitor of EGFR and celecoxib is a FDA approved COX-2 inhibitor. Both have been well studied in humans and appear to have less severe toxicity than conventional chemotherapeutic agents.', 'detailedDescription': 'Despite advances in the treatment of head and neck cancer, locoregional recurrences are the predominant site of treatment failure and are frequently the cause of death. Second primary tumors in the head and neck occur in up to 30% of patients at 10 years of follow-up after eradication of the original tumor due to field cancerization. The standard approach to patients with recurrent but non-metastatic disease has been surgical salvage alone. Unfortunately, this strategy is feasible in only a select group of patients and 5 year survival rates have ranged from 15-40%.\n\nMost patients with previously irradiated unresectable recurrent or metastatic head and neck cancer are treated with chemotherapy alone. This approach has offered limited palliation with response rates of 10-40%, median survival of 5 to 10 months. While this may be an acceptable option for patients with clearly incurable widespread metastatic disease, it may not be the best approach for those patients with potentially curable locoregional disease.\n\nWhile geographic misses and second primary tumors occur, the majority of patients have radioresistant tumors. Therefore, reirradiation alone is unlikely to be effective. High dose reirradiation with concomitant chemotherapy represents a more aggressive approach resulted in encouraging 3-year survival rates of 15 to 35%. This approach represents a potentially curative option for patients with unresectable or partially resected disease arising in a previously irradiated volume. However, the high rates of acute and late toxicity with this approach have limited widespread application of this approach.\n\nExtensive preclinical and clinical data suggest that both epidermal growth factor receptor (EGFR) antagonists and cyclooxygenase-2 (COX-2) inhibitors enhance the effectiveness of ionizing radiation. In locally advanced head and neck cancer, a recent phase III trial concurrent anti-EGFR monoclonal antibody and radiation demonstrated improved local control, disease free survival and overall survival compared to radiation alone without the increased mucosal toxicity associated with concurrent chemotherapy. COX-2 inhibition and anti-EGFR therapy demonstrates activity against recurrent/metastatic head and neck cancer in a recent phase I study. Head and neck cancer represents an ideal site to study biologic markers of tumor response because of the accessibility of tumors for biopsy. Therefore, we propose the combination of Erlotinib and Celecoxib with radiation in a cohort of previously irradiation patients with head and neck cancer.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age 18 years or older\n* Histologically or cytologically confirmed diagnosis of squamous cell or poorly differentiated carcinomas of the head and neck or lymphoepithelioma\n* Prior radiation to the head and neck, surgery or chemotherapy is allowed\n* Karnofsky performance status of \\>= 70%\n* Intact organ and bone marrow function\n* Obtained informed consent\n\nExclusion Criteria:\n\n* Demonstration of metastatic disease (i.e. M1 disease).\n* Incomplete healing from previous surgery\n* Pregnancy or breast feeding (men and women of child-bearing potential are eligible but must consent to using effective contraception during therapy and for at least 3 months after completing therapy)\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (CHF), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements\n* Patients with clinically significant pulmonary dysfunction, cardiomyopathy, or any history of clinically significant CHF are excluded. The exclusion of patients with active coronary artery disease will be at the discretion of the attending physician.\n* Uncontrolled active infection unless curable with treatment of their cancer.'}, 'identificationModule': {'nctId': 'NCT00970502', 'briefTitle': 'Erlotinib, Celecoxib and Reirradiation for Recurrent Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'Phase I/II Dose Escalation Trial of Induction and Concomitant Erlotinib and Celecoxib With Radiation Therapy for Treatment of Poor Prognosis Head and Neck Cancer, Including Reirradiation', 'orgStudyIdInfo': {'id': 'GCO 06-0509'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'erlotinib + celecoxib', 'interventionNames': ['Drug: erlotinib + celecoxib']}], 'interventions': [{'name': 'erlotinib + celecoxib', 'type': 'DRUG', 'otherNames': ['Tarceva', 'Celebrex'], 'description': 'In this phase I/II study, patients will be treated with daily erlotinib 150 mg and twice-daily celecoxib 200 to 600 mg for 14 days. Re-irradiation with IMRT will start on day 15 and will continue for 5.5 to 6.5 weeks along with erlotinib and celecoxib. After completion of radiation, patients will be given the option of continuing on erlotinib for 2 years or until unacceptable toxicity or disease progression', 'armGroupLabels': ['erlotinib + celecoxib']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Mount Sinai School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Johnny Kao, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johnny Kao', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Johnny Kao', 'investigatorAffiliation': 'Icahn School of Medicine at Mount Sinai'}}}}