Ignite Creation Date:
2025-12-24 @ 10:14 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT00968435
Status:
COMPLETED
Last Update Posted:
2016-08-10
First Post:
2009-08-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D002945', 'term': 'Cisplatin'}, {'id': 'D000068818', 'term': 'Cetuximab'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'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': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D017671', 'term': 'Platinum Compounds'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-08', 'lastUpdateSubmitDate': '2016-08-09', 'studyFirstSubmitDate': '2009-08-28', 'studyFirstSubmitQcDate': '2009-08-28', 'lastUpdatePostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-08-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To determine the 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.', 'timeFrame': '2 years'}], 'secondaryOutcomes': [{'measure': 'To determine median overall survival for patients with locally or regionally advanced HNSCC treated with concurrent IMRT + cisplatin + bevacizumab + cetuximab.', 'timeFrame': '2 years'}, {'measure': 'To evaluate the safety and tolerability of concurrent IMRT + cisplatin + bevacizumab + cetuximab.', 'timeFrame': '2 years'}, {'measure': 'To explore the potential utility of 18F FLT PET for early response assessment.', 'timeFrame': '2 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['bevacizumab', 'cisplatin', 'cetuximab', 'radiation therapy', 'Phase II', '09-083'], 'conditions': ['Head and Neck Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mskcc.org/mskcc/html/44.cfm', 'label': 'Memorial Sloan Kettering Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of treatment with bevacizumab + cisplatin + cetuximab + IMRT. The doctor wishes to monitor patients for 2 years after the completion of study treatment to determine if they are cancer-free during that time. They also want to evaluate the side effects that patients experience with this treatment regimen.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Stage III/IV HNSCC without distant metastasis. Patients with stage II squamous cell carcinoma of the hypopharynx will also be eligible\n* Adequate renal function, with serum creatinine ≤ 1.5 mg/dL. Patients with serum creatinine \\> 1.5 mg/dL may be eligible if calculated creatinine clearance \\> or = to 55 ml/min by Cockcroft and Gault equation (or 24-hour urine collection).\n* Age \\> or = to 18 years.\n* Karnofsky performance status \\> or = to 70%\n* Adequate bone marrow function: absolute neutrophil count \\> or = to 1,500/ platelets \\> or = to 100,000/ul, hemoglobin \\> or = to 9 gm/dl\n* Adequate hepatic function: Total bilirubin ≤ 1.5 X ULN (patients with Gilbert's syndrome as the cause of hyperbilirubinemia may be eligible if total bilirubin ≤ 2.5 X ULN), aspartate aminotransferase (AST) ≤ 2.5 X ULN, alanine aminotransferase (ALT) ≤ 2.5 X ULN, alkaline phosphatase ≤ 2.5 X ULN.\n* Men and women of childbearing potential must be willing to consent to using effective contraception while on treatment and for at least 3 months thereafter.\n* Patients must have ability to understand and the willingness to sign a written informed consent document.\n\nExclusion Criteria:\n\n* Prior radiation therapy for HNSCC\n* Prior treatment of HNSCC with bevacizumab or other agents specifically targeting VEGF\n* Prior treatment of HNSCC with cetuximab or other agents specifically targeting EGFR\n* Other active malignancy, other than indolent malignancies, which the investigator determines are unlikely to interfere with treatment or efficacy analysis. For example, patients with non-melanoma skin cancer, in situ carcinoma of the cervix, or prostate cancer within the no current biochemical (PSA) or radiologic evidence of disease may enroll.\n* Patients with nasopharyngeal carcinoma\n* Patients who will receive amifostine as part of the radiation treatment plan\n* Patients with skin breakdown/ulceration (CTCAE version 3.0, grade 2 or higher).\n* Patients with hearing loss requiring hearing aid or intervention (i.e. interfering in a clinically significant way with activities of daily living).\n* Patients with multifocal peripheral sensory alterations or paresthesias (including tingling) interfering with function, per patient report (example: activities of daily living).\n* Any prior documented history of transient ischemic attack (TIA) or cerebrovascular accident (CVA)\n* History of unstable angina or myocardial infarction (MI) within the last year.\n* Urine protein: creatinine (UPC) ratio \\> or = to 1.0 at screening. A random urine sample is collected. Total protein (mg/dL) and spot creatinine (mg/dL) are ordered for this sample. The UPC ratio is calculated from the results of these tests.\n* International normalized ratio (INR) \\> 1.5 or activated partial thromboplastin time (aPTT) \\> 1.5 X upper limits of normal (ULN)\n* Current use of warfarin, current use of heparin or low-molecular weight heparin, chronic daily treatment with aspirin (\\> 325 mg/day) or nonsteroidal anti-inflammatory medications known to inhibit platelet function.\n* Patients with gross hemoptysis or hematemesis (defined as bright red blood of 1 teaspoon of more) within 28 days prior to Day 0 protocol treatment will be excluded from this trial. Patients with incidental blood mixed with phlegm are not excluded.\n* Esophageal varices, non-healing ulcer, wound, or bone fracture are exclusion criteria. However, patients with skin breakdown overlying malignant neck lymphadenopathy may be eligible, at the discretion of the investigator.\n* Anatomic lesion that increases the risk of serious hemorrhage, such as encasement or invasion of major blood vessels by primary tumor and/or by involved lymph nodes\n* Blood pressure of \\> 150/100 mmHg\n* New York Heart Association (NYHA) Grade II or greater congestive heart failure.\n* Clinically significant peripheral vascular disease\n* History of bleeding diathesis or hemorrhagic disorder, or coagulopathy.\n* Major surgical procedure or significant traumatic injury within 28 days prior to treatment with bevacizumab\n* Core biopsy within 7 days prior to treatment with bevacizumab.\n* Minor surgical procedures such as fine needle aspirations or placement of percutaneous gastrostomy tube (PEG) less than 7 days prior to treatment with bevacizumab\n* History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within 6 months prior enrollment.\n* Inability to comply with study and/or follow-up procedures\n* Women who are pregnant or lactating"}, 'identificationModule': {'nctId': 'NCT00968435', 'briefTitle': 'Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma', 'organization': {'class': 'OTHER', 'fullName': 'Memorial Sloan Kettering Cancer Center'}, 'officialTitle': 'Phase II Trial of Bevacizumab, Cetuximab, and Cisplatin With IMRT (Intensity-Modulated Radiation Therapy) for Patients With Stage III/IV Head and Neck Squamous Cell Carcinoma', 'orgStudyIdInfo': {'id': '09-083'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '(IMRT) + cisplatin + bevacizumab + cetuximab', 'description': 'This is a single-institution, non-randomized, phase II study. The primary endpoint is to determine 2-year progression-free survival for patients with locally or regionally advanced HNSCC treated with concurrent intensity modulated radiation therapy (IMRT) + cisplatin + bevacizumab + cetuximab.', 'interventionNames': ['Other: bevacizumab, cisplatin, cetuximab, radiation therapy']}], 'interventions': [{'name': 'bevacizumab, cisplatin, cetuximab, radiation therapy', 'type': 'OTHER', 'description': 'Patients will receive intensity-modulated radiation therapy (IMRT) in once-daily fractions. A total dose of 70Gy is planned for the primary tumor site over approximately 33 treatment days. Day 1 will refer to the first day of radiation therapy. Concurrent with radiation therapy, patients will receive cisplatin (50 mg/m2 IV on Days 1, 2 and 22, 23) and bevacizumab (15 mg/kg IV on Days 1 and 22). Cetuximab will be administered according to the Bonner regimen (4),with a loading dose approximately 7 days prior to the start of radiation therapy (400 mg/m2 IV once, on approximately Day minus 7), followed by weekly cetuximab infusions (250 mg/m2 IV weekly X 7 infusions) until the completion of radiation therapy.', 'armGroupLabels': ['(IMRT) + cisplatin + bevacizumab + cetuximab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '07939', 'city': 'Basking Ridge', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center at Basking Ridge', 'geoPoint': {'lat': 40.70621, 'lon': -74.54932}}, {'zip': '11725', 'city': 'Commack', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center at Commack', 'geoPoint': {'lat': 40.84288, 'lon': -73.29289}}, {'zip': '10065', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11570', 'city': 'Rockville Centre', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center at Mercy Medical Center', 'geoPoint': {'lat': 40.65871, 'lon': -73.64124}}, {'zip': '10591', 'city': 'Sleepy Hollow', 'state': 'New York', 'country': 'United States', 'facility': 'Memorial Sloan Kettering Cancer Center at Phelps Memorial Hospital Center', 'geoPoint': {'lat': 41.08565, 'lon': -73.85847}}], 'overallOfficials': [{'name': 'David Pfister, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Memorial Sloan Kettering Cancer Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}