Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-25 @ 9:11 PM
Study NCT ID:
NCT00140556
Status:
COMPLETED
Last Update Posted:
2013-01-18
First Post:
2005-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced 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'}, {'id': 'D010610', 'term': 'Pharyngeal Neoplasms'}, {'id': 'D014067', 'term': 'Tonsillar Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010039', 'term': 'Otorhinolaryngologic Neoplasms'}, {'id': 'D010608', 'term': 'Pharyngeal Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D009959', 'term': 'Oropharyngeal Neoplasms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059248', 'term': 'Chemoradiotherapy'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069347', 'term': 'Erlotinib Hydrochloride'}], 'ancestors': [{'id': 'D003131', 'term': 'Combined Modality Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'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': 'david.brizel@duke.edu', 'phone': '919 668-5637', 'title': 'David Brizel, MD', 'organization': 'Duke University Medical Center, Dept Radiation Oncology'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Acute adverse events through 30 days post end of treatment. Possibly related to chemoradiotherapy greater than grade 1. Late radiotherapy related adverse events through 2 years.', 'description': 'Toxicity assessment weekly during treatment, and post treatment at 1 month and every 3 months through year 2.', 'eventGroups': [{'id': 'EG000', 'title': 'Entire Study Population', 'otherNumAtRisk': 28, 'otherNumAffected': 28, 'seriousNumAtRisk': 28, 'seriousNumAffected': 15}], 'otherEvents': [{'term': 'Anorexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 18}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dental, periodontal disease', 'notes': 'Late radiation effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 5}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dry Mouth', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 6}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dysphagia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 13}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 9}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hiccough', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 4}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucosal Infection', 'notes': 'Oral candiasis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 17}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis, Oropharyngeal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 26}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 21}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Osteonecrosis', 'notes': 'Late radiation effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 5}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Radiation Dermatitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 10}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Rash', 'notes': 'Erlotinib (Tarceva) rash', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 15}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Soft Tissue Necrosis', 'notes': 'Late radiation effect', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numAffected': 8}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Weight Loss', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 15, 'numAffected': 15}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'seriousEvents': [{'term': 'Bradycardia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 7, 'numAffected': 7}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Febrile Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 4, 'numAffected': 3}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Fever', 'notes': 'Fever (in the absence of neutropenia)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Mucositis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 5, 'numAffected': 4}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Pneumonitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}, {'term': 'Vasculitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'CTCAE (3.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Tumor Resolution', 'denoms': [{'units': 'Participants', 'counts': [{'value': '26', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Entire Study Population'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Within 30 days of completing RT', 'description': 'Complete response (resolution) of tumor on clinical exam.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': '2 participants had occult primaries, thus were not included in clinical complete response'}, {'type': 'SECONDARY', 'title': 'Local Regional Control', 'timeFrame': '1 yr following chemoradiation', 'reportingStatus': 'NOT_POSTED'}, {'type': 'SECONDARY', 'title': 'Failure Free Survival', 'timeFrame': '3 yrs', 'reportingStatus': 'NOT_POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Entire Study Population'}], 'periods': [{'title': 'Pre Radiation Period: Avastin / Tarceva', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}, {'title': 'Chemoradiotherapy Period', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Participants were recruited from the multidisciplinary ENT or Radiation Oncology Clinics between September 2005 and February 2009.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Entire Study Population'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '28', 'groupId': 'BG000'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '9', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '22', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Feeding Tube', 'classes': [{'title': 'Feeding Tube Present Baseline', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}]}]}, {'title': 'No Feeding Tube at Baseline', 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'description': 'Feeding tube present before start of treatment', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-01', 'completionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-01-14', 'studyFirstSubmitDate': '2005-08-29', 'resultsFirstSubmitDate': '2010-08-19', 'studyFirstSubmitQcDate': '2005-08-29', 'lastUpdatePostDateStruct': {'date': '2013-01-18', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-01', 'studyFirstPostDateStruct': {'date': '2005-09-01', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tumor Resolution', 'timeFrame': 'Within 30 days of completing RT', 'description': 'Complete response (resolution) of tumor on clinical exam.'}], 'secondaryOutcomes': [{'measure': 'Local Regional Control', 'timeFrame': '1 yr following chemoradiation'}, {'measure': 'Failure Free Survival', 'timeFrame': '3 yrs'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['head and neck cancer', 'targeted therapy', 'bevacizumab', 'erlotinib', 'Tarceva', 'radiotherapy', 'concurrent chemotherapy', 'pharynx cancer', 'tonsil cancer', 'hyperfractionation', 'angiogenesis', 'epidermal growth factor', 'vascular endothelial growth factor', 'magnetic resonance spectroscopy', 'cancer of the head and neck', 'upper aerodigestive tract neoplasms', 'pharynx neoplasms'], 'conditions': ['Head and Neck Cancer', 'Pharynx Cancer']}, 'referencesModule': {'references': [{'pmid': '10665787', 'type': 'BACKGROUND', 'citation': 'Brizel DM, Dodge RK, Clough RW, Dewhirst MW. Oxygenation of head and neck cancer: changes during radiotherapy and impact on treatment outcome. Radiother Oncol. 1999 Nov;53(2):113-7. doi: 10.1016/s0167-8140(99)00102-4.'}, {'pmid': '9632446', 'type': 'BACKGROUND', 'citation': 'Brizel DM, Albers ME, Fisher SR, Scher RL, Richtsmeier WJ, Hars V, George SL, Huang AT, Prosnitz LR. Hyperfractionated irradiation with or without concurrent chemotherapy for locally advanced head and neck cancer. N Engl J Med. 1998 Jun 18;338(25):1798-804. doi: 10.1056/NEJM199806183382503.'}, {'pmid': '11567808', 'type': 'BACKGROUND', 'citation': 'Brizel DM, Schroeder T, Scher RL, Walenta S, Clough RW, Dewhirst MW, Mueller-Klieser W. Elevated tumor lactate concentrations predict for an increased risk of metastases in head-and-neck cancer. Int J Radiat Oncol Biol Phys. 2001 Oct 1;51(2):349-53. doi: 10.1016/s0360-3016(01)01630-3.'}, {'pmid': '15667971', 'type': 'BACKGROUND', 'citation': 'Dewhirst MW, Poulson JM, Yu D, Sanders L, Lora-Michiels M, Vujaskovic Z, Jones EL, Samulski TV, Powers BE, Brizel DM, Prosnitz LR, Charles HC. Relation between pO2, 31P magnetic resonance spectroscopy parameters and treatment outcome in patients with high-grade soft tissue sarcomas treated with thermoradiotherapy. Int J Radiat Oncol Biol Phys. 2005 Feb 1;61(2):480-91. doi: 10.1016/j.ijrobp.2004.06.211.'}, {'pmid': '15144951', 'type': 'BACKGROUND', 'citation': 'Moeller BJ, Cao Y, Li CY, Dewhirst MW. Radiation activates HIF-1 to regulate vascular radiosensitivity in tumors: role of reoxygenation, free radicals, and stress granules. Cancer Cell. 2004 May;5(5):429-41. doi: 10.1016/s1535-6108(04)00115-1.'}, {'pmid': '20632579', 'type': 'RESULT', 'citation': 'Craciunescu O, Brizel D, Cleland E, Yoo D, Muradyan N, Carroll M, Barboriak D, MacFall J. Dynamic contrast enhanced-MRI in head and neck cancer patients: variability of the precontrast longitudinal relaxation time (T10). Med Phys. 2010 Jun;37(6):2683-92. doi: 10.1118/1.3427487.'}, {'pmid': '22253412', 'type': 'DERIVED', 'citation': 'Yoo DS, Kirkpatrick JP, Craciunescu O, Broadwater G, Peterson BL, Carroll MD, Clough R, MacFall JR, Hoang J, Scher RL, Esclamado RM, Dunphy FR, Ready NE, Brizel DM. Prospective trial of synchronous bevacizumab, erlotinib, and concurrent chemoradiation in locally advanced head and neck cancer. Clin Cancer Res. 2012 Mar 1;18(5):1404-14. doi: 10.1158/1078-0432.CCR-11-1982. Epub 2012 Jan 17.'}, {'pmid': '21985945', 'type': 'DERIVED', 'citation': 'Craciunescu OI, Yoo DS, Cleland E, Muradyan N, Carroll MD, MacFall JR, Barboriak DP, Brizel DM. Dynamic contrast-enhanced MRI in head-and-neck cancer: the impact of region of interest selection on the intra- and interpatient variability of pharmacokinetic parameters. Int J Radiat Oncol Biol Phys. 2012 Mar 1;82(3):e345-50. doi: 10.1016/j.ijrobp.2011.05.059. Epub 2011 Oct 8.'}]}, 'descriptionModule': {'briefSummary': 'Radiotherapy (RT) with concurrent chemotherapy represents the state of the art in curative intent treatment for locally advanced squamous carcinoma of the head and neck. Tumor hypoxia and high levels of angiogenesis (blood vessel formation) are associated with treatment failure. Preclinical models reveal that radiotherapy itself may induce tumor secretion of vascular endothelial growth factor (VEGF). Curability may consequently be reduced by multiple mechanisms. Over-expression of epidermal growth factor receptor (EGFR) also occurs commonly and increases the risk of treatment failure. The addition of EGFR blockade to RT alone increases the chance of a cure. Concurrent VEGF and EGFR blockade could be synergistic with one another and improve the effectiveness of concurrent chemoradiation for advanced head and neck cancer.\n\nThis study will add angiogenic and epidermal growth factor receptor (EGFR) blockade into an established program of curative intent concurrent chemoradiation for locally advanced head and neck cancer. The safety and effectiveness of delivering the drugs bevacizumab and Tarceva in conjunction with twice daily irradiation and concurrent cisplatin (CDDP) chemotherapy will be determined.', 'detailedDescription': 'Pre Radiation Period:\n\n* Bevacizumab (10 mg/kg) on days -14 and 0, or\n* Tarceva (100 mg) daily from -14-0, or\n* Bevacizumab (10 mg/kg) on days -14 and 0; Tarceva (100 mg) daily from -14-0\n\nChemoradiation Period:\n\n* Radiotherapy may be delivered via conventional 2-D, conformal 3-D, or intensity modulated (IMRT) technique as is clinically indicated. Radiotherapy and CDDP doses will be delivered uniformly to all treatment cohorts:\n\n * RT: 1.25 Gy BID M-F with a 6 hour interfraction interval\n * Treatment break during week 4. Total dose 70 Gy/7 weeks\n * CDDP: 33 mg/m2 M-W on weeks 1 and 5 of RT with standard DUMC hydration and anti-emetic regimens\n* Bevacizumab (10mg/kg): Monday of weeks 1, 3, 5, 7 of RT\n* Tarceva (100 mg): Daily for weeks 1-7 of treatment, except for days receiving CDDP\n\nSafety Assessments:\n\n* Baseline and then weekly assessments of blood pressure and urine protein : creatinine ratios during lead in and chemoRT phases of treatment\n* Baseline carotid Doppler ultrasound evaluation\n* Carotid Doppler ultrasound evaluation 1 month post-chemoRT\n\nEfficacy Assessments:\n\n* MR Imaging/Spectroscopy to be done at baseline, end of lead-in phase, end of week 1 of chemoRT, and end of chemoRT\n* Angiogenic and EGFR related cytokines. Specifically, blood samples will be obtained to assay levels of VEGF, b-FGF, IL-8, D-dimer, EGF, TGF. These samples will be obtained on the same dates as the MR studies with an additional set of samples obtained at the midpoint of the lead in phase of treatment (day -7).\n\nClinical Assessments:\n\n* All patients will undergo a minimum of once weekly interval history and physical examination including fiberoptic pharyngoscopy/laryngoscopy when indicated in the Department of Radiation Oncology to monitor for side effects and response to treatment as per standard routine for the care of patients with head and neck cancer.\n* Patient compliance with Tarceva administration monitored via diary MRI/MRS (Magnetic Resonance Spectroscopy) DE-MRI'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Locally advanced squamous carcinoma of the head and neck (AJCC stages II/IV, M0, and excluding T1N1 and T1N2) undergoing curative intent concurrent chemoradiation.\n* Previous treatment of any sort other than a biopsy is not allowed.\n* Eligible anatomic sites:\n\n * oral cavity\n * oropharynx\n * hypopharynx\n * supraglottic\n * glottic larynx\n* KPS \\> 60\n\nExclusion Criteria:\n\n* Nasopharynx primary\n* History of malignancy other than basal cell skin cancer.\n* History of claudication, bleeding, or thromboembolic disorders. Patients receiving heparin or Coumadin therapy are ineligible.\n* Primary tumor or lymph node encasement of the carotid artery\n* Blood pressure of \\>150/100 mmHg\n* Unstable angina\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure\n* History of myocardial infarction within 6 months\n* History of stroke within 6 months\n* Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0; anticipation of need for major surgical procedure during the course of the study.\n* Minor surgical procedures, fine needle aspirations, or core biopsies within 7 days prior to Day 0\n* Pregnant (positive pregnancy test) or lactating\n* Urine protein : creatinine ratio ≥ 1.0 at screening\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior to Day 0\n* Serious, non-healing wound, ulcer, or bone fracture\n* AST, ALT, or bilirubin \\> 1.5 x normal\n* PT or PTT \\> 1.5 x normal\n* Platelets \\< 100,000\n* WBC \\< 2000\n* Hgb \\< 10\n* Creatinine clearance \\< 60 mL/hr\n* Refusal to provide written informed consent'}, 'identificationModule': {'nctId': 'NCT00140556', 'briefTitle': 'Angiogenic and EGFR Blockade With Curative Chemoradiation for Advanced Head and Neck Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Concurrent Angiogenic and EGFR Blockade in Conjunction With Curative Intent Chemoradiation for Locally Advanced Head and Neck Cancer', 'orgStudyIdInfo': {'id': 'Pro00008840'}, 'secondaryIdInfos': [{'id': '7077', 'type': 'OTHER', 'domain': 'Legacy IRB number'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ChemoRadiotherapy', 'description': 'Radiation Therapy concurrent with cisplatin chemotherapy, Avastin and Tarceva', 'interventionNames': ['Radiation: Chemoradiotherapy', 'Drug: Cisplatin', 'Drug: Bevacizumab', 'Drug: Erlotinib']}], 'interventions': [{'name': 'Chemoradiotherapy', 'type': 'RADIATION', 'description': 'External beam radiation daily (M-F)', 'armGroupLabels': ['ChemoRadiotherapy']}, {'name': 'Cisplatin', 'type': 'DRUG', 'description': 'Cisplatin week 1 and 5 of radiation', 'armGroupLabels': ['ChemoRadiotherapy']}, {'name': 'Bevacizumab', 'type': 'DRUG', 'otherNames': ['Avastin'], 'description': 'Bevacizumab (Avastin) day 1 of weeks 1, 3, and 5 of radiation', 'armGroupLabels': ['ChemoRadiotherapy']}, {'name': 'Erlotinib', 'type': 'DRUG', 'otherNames': ['Tarceva'], 'description': 'Erlotinib daily during radiation', 'armGroupLabels': ['ChemoRadiotherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27710', 'city': 'Durham', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Department of Radiation Oncology; Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'overallOfficials': [{'name': 'David M Brizel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiation Oncology; Duke University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'David M. Brizel, MD', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}, {'name': 'OSI Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor, Radiation Oncology', 'investigatorFullName': 'David M. Brizel, MD', 'investigatorAffiliation': 'Duke University'}}}}