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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
| National Comprehensive Cancer Network | NETWORK |
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The purpose of this study is to find out what effects, good and/or bad, 2 doses of Cetuximab will have on head and neck cancer. The study is done because 250 mg/m2 given weekly does not work very well. Doses as high as 700 mg/m2 every other week appear to be no more toxic, so we will try to determine if 500 mg/m2 and 750 mg/m2 given every other week can work better. We do not know if it will help. We can use what we learn from this research study to help other people with the same disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cetuximab 500 mg/m^2 | Active Comparator | Cetuximab 500 mg/m^2 IV over 2 hours every other week |
|
| Cetuximab 750 mg/m^2 | Active Comparator | Cetuximab 750 mg/m^2 IV over 3 hours every other week |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cetuximab | Biological | Cetuximab 500 mg/m^2 IV over 2 hours every other week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Overall Objective Response | Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam | Approximately every 8 weeks with imaging up to two years |
| Measure | Description | Time Frame |
|---|---|---|
| The Total Number of Participants That Were Effected by Adverse Events. | Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity. | at least weekly |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew Fury, MD,PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope National Medical Center | Duarte | California | 91010-3000 | United States | ||
| H. Lee Moffit Cancer Center and Research Institute |
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| Label | URL |
|---|---|
| Memorial Sloan-Kettering Cancer Center | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | Cetuximab Infusion at 500 mg/m^2 | Cetuximab infusion at 500 mg/m^2 over 2 hours every other week. |
| FG001 | Cetuximab Infusion at 750 mg/m^2 | Cetuximab infusion at 750 mg/m^2 over 3 hours every other week. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| cetuximab | Biological | Cetuximab 750 mg/m^2 IV over 3 hours every other week |
|
|
| Tampa |
| Florida |
| 33612 |
| United States |
| NorthShore University Health System | Evanston | Illinois | 60201 | United States |
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
| University of Nebraska Medical Center | Omaha | Nebraska | 68198-7680 | United States |
| Memorial Sloan-Kettering Cancer Center at Basking Ridge | Basking Ridge | New Jersey | 07939 | United States |
| Memorial Sloan-Kettering Cancer Center at Commack | Commack | New York | 11725 | United States |
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
| Memorial Sloan-Kettering at Mercy Medical Center | Rockville Centre | New York | United States |
| Memoral Sloan Kettering Cancer Center@Phelps | Sleepy Hollow | New York | United States |
| Fox Chase Virtua Health Cancer Program | Philadelphia | Pennsylvania | 08060 | United States |
| University of Pennsylvania - Abramson Cancer Center | Philadelphia | Pennsylvania | 19104-4283 | United States |
| Abramson Cancer Center University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
| Pennsylvania Hospital | Philadelphia | Pennsylvania | 19106 | United States |
| Fox Chase Cancer Center | Philadelphia | Pennsylvania | 19111 | United States |
| University of Tennessee Cancer Institute | Memphis | Tennessee | 38104 | United States |
| Huntsman Cancer Institue | Salt Lake City | Utah | 84112 | United States |
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm A | Cetuximab infusion at 500 mg/m2 over 2 hours every other week. |
| BG001 | Arm B | Cetuximab infusion at 750 mg/m2 over 3 hours every other week. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Patients With Overall Objective Response | Patients will be evaluated for response according to a modified version of the Response Evaluation Criteria in Solid Tumors (RECIST) guidelines. Target lesions: Complete Response (CR): The disappearance of all target lesions. To be assigned a status of complete response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Partial Response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions,taking as reference the baseline sum longest diameter. To be assigned a status of partial response, changes in tumor measurements must be confirmed by repeat assessments performed no less than 4 weeks after the criteria for response are first met. Stable Disease (SD): Neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify progressive disease. To be assigned a status of stable disease, taking as reference the smallest sum longest diam | Posted | Number | participants | Approximately every 8 weeks with imaging up to two years |
|
|
| |||||||||||||||||||||||||||||||||||||
| Secondary | The Total Number of Participants That Were Effected by Adverse Events. | Terminology Criteria Version 3.0 or study specific toxicity tables provided in the protocol define severity. | Posted | Count of Participants | Participants | at least weekly |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm A | Cetuximab infusion at 500 mg/m2 over 2 hours every other week. | 18 | 30 | 28 | 30 | ||
| EG001 | Arm B | Cetuximab infusion at 750 mg/m2 over 3 hours every other week. | 7 | 19 | 18 | 19 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Allergic reaction (including drug fever) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Aspiration | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| CNS cerebrovascular ischemia | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Confusion | Nervous system disorders | CTC-3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not associated with CTCAE term- Death NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Death not associated with CTCAE term-Disease progression NOS | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Dehydration | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Dysphagia (Difficulty swallowing) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Fracture | Musculoskeletal and connective tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemorrhage/Bleeding, other | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Ileus, GI (func obstruction of bowel) | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Inf norm ANC/gr1/2 neut-Pneumonia(lung) | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Infection w/ Gr 3/4 neut, Lung (pneumonia) | Infections and infestations | CTC-3.0 | Systematic Assessment |
| |
| Nausea | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Neuroendocrine: ADH secretion abnormal | Endocrine disorders | CTC-3.0 | Systematic Assessment |
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| Pain | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Potassium, low (hypokalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Somnolence/depressd level of conscious | Psychiatric disorders | CTC-3.0 | Systematic Assessment |
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| Vomiting | General disorders | CTC-3.0 | Systematic Assessment |
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| Calcium, high (hypercalcemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Extremity-lower (gait/walking) | Musculoskeletal and connective tissue disorders | CTC-3.0 | Systematic Assessment |
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| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
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| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Muscle weakness - Whole body/general | Musculoskeletal and connective tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Pleural effusion (non-malignant) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Albumin, low (hypoalbuminemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Anorexia | General disorders | CTC-3.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Dehydration | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Dyspnea (shortness of breath) | Respiratory, thoracic and mediastinal disorders | CTC-3.0 | Systematic Assessment |
| |
| Fatigue (asthenia, lethargy, malaise) | General disorders | CTC-3.0 | Systematic Assessment |
| |
| Glucose, high (hyperglycemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Hemoglobin | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Lymphopenia | Blood and lymphatic system disorders | CTC-3.0 | Systematic Assessment |
| |
| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
| |
| Mood alteration - Anxiety | Psychiatric disorders | CTC-3.0 | Systematic Assessment |
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| Mucositis (func/sympt)- Oral cavity | General disorders | CTC-3.0 | Systematic Assessment |
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| Muscle weakness - Whole body/general | General disorders | CTC-3.0 | Systematic Assessment |
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| Nail changes | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Pain | General disorders | CTC-3.0 | Systematic Assessment |
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| Phosphate, low (hypophosphatemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Rash/desquamation | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Rash: acne/acneiform | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
| |
| Sodium, low (hyponatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Trismus | General disorders | CTC-3.0 | Systematic Assessment |
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| Weight loss | General disorders | CTC-3.0 | Systematic Assessment |
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| Vomiting | General disorders | CTC-3.0 | Systematic Assessment |
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| Tinnitus | Ear and labyrinth disorders | CTC-3.0 | Systematic Assessment |
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| Taste alteration (dysgeusia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Syncope (fainting) | General disorders | CTC-3.0 | Systematic Assessment |
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| Sodium, high (hypernatremia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Skin breakdown/decubitus ulcer | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Pruritus/itching | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Potassium, high (hyperkalemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Neuropathy: motor | Nervous system disorders | CTC-3.0 | Systematic Assessment |
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| Nausea | General disorders | CTC-3.0 | Systematic Assessment |
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| Magnesium, low (hypomagnesemia) | Metabolism and nutrition disorders | CTC-3.0 | Systematic Assessment |
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| Infection, other | Infections and infestations | CTC-3.0 | Systematic Assessment |
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| Inf norm ANC/gr1/2 neut | Infections and infestations | CTC-3.0 | Systematic Assessment |
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| Flushing | Skin and subcutaneous tissue disorders | CTC-3.0 | Systematic Assessment |
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| Dry mouth/salivary gland (xerostomia) | General disorders | CTC-3.0 | Systematic Assessment |
|
For safety data please see adverse events
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. David Pfister | Memorial Sloan Kettering Cancer Center | 646-888-4237 | pfisterd@mskcc.org |
| ID | Term |
|---|---|
| D018307 | Neoplasms, Squamous Cell |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D000068818 | Cetuximab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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| >=65 years |
|
| Male |
|
| Progression of Disease (POD) |
|
|