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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-00113 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| CDR0000433404 | |||
| PHII-57 | Other Identifier | City of Hope | |
| 7003 | Other Identifier | CTEP | |
| N01CM62208 | U.S. NIH Grant/Contract | View source | |
| N01CM62201 | U.S. NIH Grant/Contract | View source | |
| N01CM62209 | U.S. NIH Grant/Contract | View source | |
| N01CM62207 | U.S. NIH Grant/Contract | View source |
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This phase II trial is studying how well bortezomib works in treating patients with stage IIIB or stage IV lung cancer. Bortezomib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. Determine the objective response rate in patients with stage IIIB or IV bronchoalveolar carcinoma (BAC) or adencarcinoma of the lung with BAC features treated with bortezomib.
SECONDARY OBJECTIVES:
I. Determine the progression-free and overall survival of patients treated with this drug.
II. Determine the time to disease progression in patients treated with this drug.
III. Determine predictors of response, based on molecular correlative studies of tumor and blood, in patients with treated with this drug.
OUTLINE: This is a multicenter study. Patients are stratified according to prior epidermal growth factor receptor inhibitor therapy (yes vs no).
Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed for survival.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I | Experimental | Patients receive bortezomib IV over 3-5 seconds on days 1 and 8. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bortezomib | Drug | Given IV |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis. | A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR. | Up to 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival | Progression Free Survival using the product-limit method of Kaplan and Meier | Up to 5 years |
| Overall Survival | Overall Suvival using the product-limit method of Kaplan and Meier. |
Not provided
Criteria:
Histologically confirmed bronchoalveolar carcinoma (BAC) or adenocarcinoma of the lung with BAC features:
Measurable disease, defined as >= 1 unidimensionally measurable lesion >= 20 mm by conventional techniques or >= 10 mm by spiral CT scan:
No unstable brain metastases:
Performance status:
Life expectancy >3 months
Hepatic:
Renal:
Cardiovascular:
No more than 1 prior chemotherapy regimen for advanced BAC:
At least 3 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin)
At least 4 weeks since prior corticosteroids
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception before, during, and for 30 days after completion of study treatment
No ongoing or active infection
No other malignancy within the past 3 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer that is in complete remission
No peripheral neuropathy >= grade 2
No known hypersensitivity to bortezomib, boron, or mannitol
No psychiatric illness or social situation that would preclude study compliance
No other uncontrolled illness
No concurrent routine granulocyte colony-stimulating factors (e.g., filgrastim [G-CSF] or sargramostim [GM-CSF])
At least 2 weeks since prior radiotherapy
Recovered from prior therapy (alopecia allowed)
At least 2 weeks since prior EGFR inhibitors
At least 4 weeks since prior anticonvulsants
No prior bortezomib
No concurrent antiretroviral therapy for HIV-positive patients
No other concurrent investigational agents
No other concurrent anticancer therapy
Concurrent bisphosphonates for bone metastases allowed
Hematopoietic:
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| Name | Affiliation | Role |
|---|---|---|
| David Gandara | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope | Duarte | California | 91010 | United States |
Not provided
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I | Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Up to 5 years |
| COMPLETED |
|
| NOT COMPLETED |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm 1 | Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Objective Response Rate With Bortezomib Evaluated by Both RECIST Criteria and Computer-assisted Image Analysis. | A response rate of 20% or more with bortezomib would be of interest for further evaluation, whereas a response rate of less than 5% would be of no interest. Response defined as a confirmed CR or PR. | Posted | Number | percentage of responders | Up to 5 years |
|
|
| |||||||||||||||||||||||||||
| Secondary | Progression-free Survival | Progression Free Survival using the product-limit method of Kaplan and Meier | Posted | Median | 95% Confidence Interval | Months | Up to 5 years |
|
|
| ||||||||||||||||||||||||||
| Secondary | Overall Survival | Overall Suvival using the product-limit method of Kaplan and Meier. | Posted | Mean | 95% Confidence Interval | Months | Up to 5 years |
|
|
|
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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 I | Patients receive bortezomib IV at 1.6 mg/m2 on days 1 and 8 of every 21 day cycle. | 12 | 42 | 42 | 42 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Upper gastrointestinal hemorrhage | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hepatic failure | Hepatobiliary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Bilirubin increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Acoustic nerve disorder NOS | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hemoglobin decreased | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Lymphangiopathy NOS | Blood and lymphatic system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Palpitations | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sinus tachycardia | Cardiac disorders | meddra9.0 | Non-systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | meddra10.0 | Non-systematic Assessment |
| |
| Endocrine disorder | Endocrine disorders | meddra9.0 | Non-systematic Assessment |
| |
| Cataract | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dry eye syndrome | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flashing vision | Eye disorders | meddra9.0 | Non-systematic Assessment |
| |
| Vision blurred | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Watering eyes | Eye disorders | meddra10.0 | Non-systematic Assessment |
| |
| Abdominal distension | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ear, nose and throat examination abnormal | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Mucositis oral | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Stomach pain | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Toothache | Gastrointestinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Chest pain | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chills | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Death | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Disease progression | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Edema limbs | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fatigue | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Fever | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flu-like symptoms | General disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ill-defined disorder | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pain | General disorders | meddra9.0 | Non-systematic Assessment |
| |
| Gallbladder obstruction | Hepatobiliary disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypersensitivity | Immune system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bronchitis | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Conjunctivitis infective | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Lip infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Otitis externa | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Peripheral nerve infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Pharyngitis | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Upper aerodigestive tract infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Upper respiratory infection | Infections and infestations | meddra9.0 | Non-systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | meddra10.0 | Non-systematic Assessment |
| |
| Bruising | Injury, poisoning and procedural complications | meddra10.0 | Non-systematic Assessment |
| |
| Fracture | Injury, poisoning and procedural complications | meddra9.0 | Non-systematic Assessment |
| |
| Activated partial thromboplastin time prolonged | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Alkaline phosphatase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Bilirubin increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Creatinine increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Hyperbilirubinemia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| INR increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Leukopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lipase increased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Lymphocyte count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Lymphopenia | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Neutrophil count decreased | Investigations | meddra9.0 | Non-systematic Assessment |
| |
| Platelet count decreased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Serum cholesterol increased | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Weight loss | Investigations | meddra10.0 | Non-systematic Assessment |
| |
| Anorexia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Blood bicarbonate decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Blood glucose increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hyperglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypernatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoalbuminemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoglycemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypomagnesemia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | meddra9.0 | Non-systematic Assessment |
| |
| Serum albumin decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum calcium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum glucose decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum magnesium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum phosphate decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum potassium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum potassium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum sodium decreased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum sodium increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Serum triglycerides increased | Metabolism and nutrition disorders | meddra10.0 | Non-systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Bone pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Chest wall pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Joint pain | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Muscle weakness | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Musculoskeletal disorder | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Neck pain | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Ataxia | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dizziness | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Memory impairment | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Neuralgia | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Neurological disorder NOS | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Seizure | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Speech disorder | Nervous system disorders | meddra9.0 | Non-systematic Assessment |
| |
| Syncope | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Taste alteration | Nervous system disorders | meddra10.0 | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Confusion | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Depression | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Insomnia | Psychiatric disorders | meddra10.0 | Non-systematic Assessment |
| |
| Protein urine positive | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | meddra10.0 | Non-systematic Assessment |
| |
| Allergic rhinitis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Bronchospasm | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hemorrhage nasal | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypoxia | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Laryngeal obstruction | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pharyngolaryngeal pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pleuritic pain | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pneumonitis | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Pulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Respiratory disorder | Respiratory, thoracic and mediastinal disorders | meddra9.0 | Non-systematic Assessment |
| |
| Voice alteration | Respiratory, thoracic and mediastinal disorders | meddra10.0 | Non-systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Rash desquamating | Skin and subcutaneous tissue disorders | meddra9.0 | Non-systematic Assessment |
| |
| Scalp pain | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Skin disorder | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Sweating | Skin and subcutaneous tissue disorders | meddra10.0 | Non-systematic Assessment |
| |
| Flushing | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hematoma | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hot flashes | Vascular disorders | meddra9.0 | Non-systematic Assessment |
| |
| Hypertension | Vascular disorders | meddra10.0 | Non-systematic Assessment |
| |
| Hypotension | Vascular disorders | meddra10.0 | Non-systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| DCC Project Administrator | California Cancer Consortium | 626-256-4673 | 60094 | CCCP@coh.org |
| ID | Term |
|---|---|
| D000077192 | Adenocarcinoma of Lung |
| D002282 | Adenocarcinoma, Bronchiolo-Alveolar |
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D000069286 | Bortezomib |
| ID | Term |
|---|---|
| D001897 | Boronic Acids |
| D000148 | Acids, Noncarboxylic |
| D000143 | Acids |
| D007287 | Inorganic Chemicals |
| D001896 | Boron Compounds |
| D009930 | Organic Chemicals |
| D011719 | Pyrazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
|
|