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| ID | Type | Description | Link |
|---|---|---|---|
| N01CM17102 | U.S. NIH Grant/Contract | View source | |
| CDR0000463521 | Registry Identifier | PDQ (Physician Data Query) | |
| 14203B |
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This phase II trial is studying how well cediranib maleate works in treating patients with malignant mesothelioma that cannot be removed by surgery. Cediranib maleate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor
We conducted a multi-center phase II trial of cediranib in patients with unresectable, histologically-confirmed malignant mesothelioma (MM) who had received <=1 prior regimen of chemotherapy. The primary endpoint was objective response rate. Initial cediranib dosing was 45 mg daily during a 28-day cycle. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily.
Pretreatment evaluation included a medical history and physical exam, complete blood count and differential, chemistry panel, pregnancy test, and a computed tomography (CT) scan of the chest, abdomen, and pelvis if relevant. A history and physical exam were repeated every 14 days and laboratory evaluations including a complete blood count with differential, serum chemistry panel, and urinalysis were repeated every 7 days. Patients were provided with a blood pressure monitoring device and a diary to record their blood pressure readings twice daily.
Patients received a minimum of 2 cycles unless unacceptable toxicity or rapid clinical progression of disease occurred. Response was evaluated by CT imaging every two cycles. Confirmatory scans were to be obtained at least 4 weeks after initial documentation of an objective complete or partial response.
Cediranib was administered orally once daily on days 1 through 28 of a 28-day cycle. Cediranib was initially dosed at 45 mg daily, but due to substantial rates of toxicity the protocol was amended in June 2007 to decrease the starting dose to 30 mg daily. Cediranib was taken 1 hour (h) before or 2 h after meals. Only one dose modification was permitted. When the starting cediranib dose was 45 mg, dose level-1 was 30 mg daily. After the protocol amendment, dose level-1 was 20 mg daily. Further dose reductions were allowed at the discretion of the investigator only if the patient had received clinical benefit from cediranib for >3 months. Patients undergo blood collection periodically during study for biomarker and optional pharmacogenomic correlative studies. After completion of study treatment, patients are followed for up to 8 weeks.
Adverse effects were graded according to National Cancer Institute Common Toxicity Criteria version 3.0. The dose was reduced for grade 3 or greater non-hematologic toxicity attributable to cediranib or grade 4 hematologic toxicity if the toxicity lasted for >5 days and did not resolve to <=grade 2. Maximal antihypertensive therapy was defined as taking 4 antihypertensive agents for >2 weeks at full dosage. For patients on antihypertensive therapy who had an elevation in systolic blood pressure (SBP) >=140 mmHg or diastolic blood pressure (DBP) >=90 mmHg on 2 separate readings during a 48 h period, the dose of cediranib was maintained without interruption while the dosage of current antihypertensive therapy was increased or an additional antihypertensive agent was started. If 2 readings reported a SBP >=180 mmHg or a DBP >=105 mmHg during a 1 week period, cediranib was held and there was either an increase in the dosage of current antihypertensive therapy or an additional antihypertensive agent was added. Resumption of cediranib was allowed only after the blood pressure was <140/90 mmHg. If 2 blood pressure readings recorded an SBP >=160 mmHg or a DBP >=105 mmHg 1 h apart during a 48 hour period in a patient already on maximal antihypertensive therapy, cediranib was held and treatment was resumed at 1 dose level lower when the blood pressure was <160/105.
PRIMARY OBJECTIVE:
I. Determine the objective response rate in patients with malignant pleural, peritoneal, or tunica vaginalis mesothelioma that is not amenable to curative surgery who are treated with AZD2171 (cediranib maleate).
SECONDARY OBJECTIVES:
I. Determine the progression-free survival of patients treated with AZD2171. II. Determine the toxicity experienced by patients treated with AZD2171. III. Determine median and overall survival of patients treated with AZD2171.
TERTIARY OBJECTIVES:
I. Generate preliminary data regarding potential utility of pharmacogenomic and plasma/serum biomarkers of angiogenesis as predictive or prognostic markers for future investigations of this drug in malignant mesothelioma.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (enzyme inhibitor therapy) | Experimental | Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cediranib maleate | Drug | Given orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate, Complete (CR) or Partial (PR) Response | Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. | Every 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Laboratory Correlates | Examined using paired t-test or Wilcoxon signed-ranks test. | Baseline, days 15 and 29 of course 1, and then every 28 days |
| Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity |
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Inclusion Criteria:
Histologically or cytologically confirmed malignant pleural, peritoneal, or tunica vaginalis mesothelioma
International Mesothelioma Interest Group stage II-IV disease (for patients with pleural mesothelioma)
Measurable disease, defined as ≥ 1 unidimensionally measurable lesion ≥ 20 mm by conventional techniques OR > 10 mm by spiral CT scan
Disease not amenable to curative surgery
No known brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1 OR Karnofsky PS 70-100%
Life expectancy > 3 months
White blood cell (WBC) ≥ 3,000/mm³
Absolute neutrophil count ≥ 1,500/mm³
Hemoglobin ≥ 8 g/dL
Platelets ≥ 100,000/mm³
Total bilirubin normal
Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) ≤ 2.5 times upper limit of normal(ULN)
Creatinine normal OR creatinine clearance > 60 mL/min
Fertile patients must use effective contraception
Not pregnant or nursing
Negative pregnancy test
No history of allergic reactions to compounds of similar chemical or biologic composition to AZD2171
Mean corrected QT interval (QTc) ≤ 500 msec (with Bazett's correction) by EKG
No history of long QT syndrome
Proteinuria ≤ 1+ on two consecutive dipsticks taken ≥ 1 week apart
No other concurrent malignancy
No New York Heart Association class III or IV cardiac disease
No uncontrolled intercurrent illness including, but not limited to, any of the following:
No more than 1 prior cytotoxic chemotherapy
At least 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C) and recovered
No prior radiotherapy to the only site of measurable disease
At least 4 weeks since prior radiotherapy and recovered
At least 4 weeks since prior major surgery and recovered
More than 30 days since prior participation in an investigational trial
No prior treatment with a vascular endothelial growth factor (VEGF) inhibitor
No other concurrent investigational agents
No concurrent commercial agents for the malignancy
No concurrent medication that may markedly affect renal function (e.g., vancomycin, amphotericin, or pentamidine)
No concurrent hematopoietic growth factors except epoetin alfa
No concurrent palliative radiotherapy
No combination antiretroviral therapy for HIV-positive patients
No concurrent drugs or biologics with proarrhythmic potential
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| Name | Affiliation | Role |
|---|---|---|
| Hedy Kindler | University of Chicago Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Chicago Comprehensive Cancer Center | Chicago | Illinois | 60637-1470 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22831987 | Result | Campbell NP, Kunnavakkam R, Leighl N, Vincent MD, Gandara DR, Koczywas M, Gitlitz BJ, Agamah E, Thomas SP, Stadler WM, Vokes EE, Kindler HL. Cediranib in patients with malignant mesothelioma: a phase II trial of the University of Chicago Phase II Consortium. Lung Cancer. 2012 Oct;78(1):76-80. doi: 10.1016/j.lungcan.2012.06.011. Epub 2012 Jul 23. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment (Enzyme Inhibitor Therapy) | Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well.
| Week 1 of course 1 |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment (Enzyme Inhibitor Therapy) | Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily. |
| 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 |
|
| 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, Complete (CR) or Partial (PR) Response | Evaluated in this study using the new international criteria proposed by the Response Evaluation Criteria in Solid Tumors (RECIST) Committee. To be assigned a status of PR or CR, changes in tumor measurements must be confirmed by repeat assessments that should be performed no less than 4 weeks after the criteria for response are first met. | Posted | Number | percentage of participants | Every 8 weeks |
|
|
| |||||||||||||||||||||||||||
| Secondary | Changes in Laboratory Correlates | Examined using paired t-test or Wilcoxon signed-ranks test. | This outcome was not measured/assessed for any of the study subjects. | Posted | Baseline, days 15 and 29 of course 1, and then every 28 days |
|
| |||||||||||||||||||||||||||||
| Secondary | Pharmacogenomics by Correlating Genetic Polymorphisms With Drug Activity and Toxicity | Focus on variants of genes in the pathway targeted by cediranib maleate, including kdr/flk-1 (the specific target of cediranib maleate) and the genes that encode Vascular endothelial growth factor A (VEGF-A) or HIF1α. If additional information relevant to other genes of interest in the pathway becomes available the samples will be utilized for such analysis as well. | This outcome was not measured/assessed for any of the study subjects. | Posted | Week 1 of course 1 |
|
|
After completion of study treatment, patients are followed for up to 8 weeks.
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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 | Treatment (Enzyme Inhibitor Therapy) | Initial cediranib maleate dosing was 45 mg (once daily) during a 28-day cycle. Courses repeated every 28 days in the absence of disease progression or unacceptable toxicity. Due to substantial toxicity, the starting dose was subsequently lowered to 30 mg daily. | 31 | 51 | 49 | 51 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Abdominal distension occurs when substances, such as air (gas) or fluid, accumulate in the abdomen causing its outward expansion beyond the normal girth of the stomach and waist. |
|
| Abdominal pain | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in the abdominal region |
|
| Alanine aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased levels of alanine aminotransferase, indicative of liver damage or disease. |
|
| Anaphylaxis | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Anaphylaxis is a serious allergic reaction that is rapid in onset and may cause death. |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Anorexia is the decreased sensation of appetite. |
|
| Aspartate aminotransferase increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased levels of aspartate aminotransferase (AST) |
|
| Atelectasis | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Atelectasis is defined as the collapse or closure of the lung resulting in reduced or absent gas exchange. |
|
| Atrial flutter | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Atrial flutter (AFL) is an abnormal heart rhythm that occurs in the atria of the heart. |
|
| Bronchopulmonary hemorrhage | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Bronchopulmonary hemorrhage is a disorder characterized by bleeding from the bronchial wall and/or lung parenchyma. |
|
| Cardiac arrest | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Cardiac arrest, also known as cardiopulmonary arrest or circulatory arrest, is the cessation of normal circulation of the blood due to failure of the heart to contract effectively. |
|
| Chest wall pain | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in the chest wall not attributed to any cardiac disorder. |
|
| Cognitive disturbance | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | A disorder characterized by a conspicuous change in cognitive function. |
|
| Conduction disorder | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Impairment of conduction in heart excitation; often applied specifically to atrioventricular heart block. |
|
| Confusion | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Loss of orientation (ability to place oneself correctly in the world by time, location, and/or personal identity sometimes accompanied by disordered consciousness and often memory (ability to correctly recall previous events or learn new material). |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass. |
|
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased levels of creatinine |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dehydration is the excessive loss of body water |
|
| Depressed level of consciousness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | A neurologic state characterized by decreased ability to perceive and respond. |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Condition of having three or more loose or liquid bowel movements per day |
|
| Dizziness | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Dizziness is an impairment in spatial perception and stability. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Dyspnea - shortness of breath. |
|
| ECG QTc interval prolonged | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Electrocardiogram QT corrected interval prolonged |
|
| Encephalopathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Syndrome of global brain dysfunction |
|
| Failure to thrive | General disorders | CTCAE (3.0) | Systematic Assessment | Insufficient weight gain or inappropriate weight loss. |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Fatigue (also called exhaustion, tiredness, lethargy, languidness, languor, lassitude, and listlessness) is a subjective feeling of tiredness which is distinct from weakness, and has a gradual onset. |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in the head or neck region. |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hyperglycemia, or high blood sugar is a condition in which an excessive amount of glucose circulates in the blood plasma. |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Elevated blood pressure in the arteries |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypoalbuminemia is a medical condition where levels of albumin in blood serum are abnormally low. |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypoglycemia is an abnormally diminished content of glucose in the blood. |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hyponatremia - An electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal. |
|
| Hypotension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Hypotension is low blood pressure. |
|
| Infection with unknown ANC: Blood | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Blood infection with unknown Absolute Neutrophil Count (ANC) |
|
| Intracranial hemorrhage | General disorders | CTCAE (3.0) | Systematic Assessment | An intracranial hemorrhage (ICH) is a hemorrhage, or bleeding, within the skull. |
|
| Lung infection | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Infection in the lung |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Lymphocyte count decreased |
|
| Mobitz (type) II atrioventricular block | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Second-degree atrioventricular (AV) block is a disease of the electrical conduction system of the heart. It refers to a conduction block between the atria and ventricles. |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Muscle weakness or myasthenia is a lack of muscle strength. |
|
| Pericardial effusion | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Pericardial effusion ("fluid around the heart") is an abnormal accumulation of fluid in the pericardial cavity. |
|
| Peripheral motor neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | A disorder characterized by inflammation or degeneration of the peripheral motor nerves. |
|
| Pleural effusion | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Pleural effusion is excess fluid that accumulates between the two pleural layers, the fluid-filled space that surrounds the lungs. |
|
| Pneumothorax | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | A pneumothorax is an abnormal collection of air or gas in the pleural space that separates the lung from the chest wall and which may interfere with normal breathing. |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Proteinuria-also called albuminuria or urine albumin-is a condition in which urine contains an abnormal amount of protein |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Pulmonary embolism (PE) is a blockage of the main artery of the lung or one of its branches by a substance that has traveled from elsewhere in the body through the bloodstream (embolism). |
|
| Seizure | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | A seizure is the physical findings or changes in behavior that occur after an episode of abnormal electrical activity in the brain. |
|
| Sepsis | Infections and infestations | CTCAE (3.0) | Systematic Assessment | Sepsis is a potentially deadly medical condition characterized by a whole-body inflammatory state (called a systemic inflammatory response syndrome or SIRS) caused by severe infection. |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Sinus tachycardia is a heart rhythm with elevated rate of impulses originating from the sinoatrial node, defined as a rate greater than 100 beats/min (bpm) in an average adult. |
|
| Small intestinal obstruction | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Intestinal obstruction is a blockage that keeps food or liquid from passing through the small intestine. |
|
| Thromboembolic event | Vascular disorders | CTCAE (3.0) | Systematic Assessment | Formation of a blood clot inside a blood vessel, obstructing the flow of blood through the circulatory system. |
|
| Urinary retention | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Urinary retention is the inability to empty the bladder. |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in the abdominal region. |
|
| Alanine aminotransferase (ALT) increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased levels of alanine aminotransferase, indicative of liver damage or disease. |
|
| Alkaline phosphatase (ALP) increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased levels of Alkaline phosphatase |
|
| Allergic rhinitis | Immune system disorders | CTCAE (3.0) | Systematic Assessment | Allergic rhinitis is an allergic inflammation of the nasal airways. |
|
| Anemia | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Anemia is a decrease in number of red blood cells (RBCs) or less than the normal quantity of hemoglobin in the blood. |
|
| Anorexia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Anorexia is the decreased sensation of appetite. |
|
| Anxiety | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Anxiety is an unpleasant state of inner turmoil and apprehension, often accompanied by nervous behavior, such as pacing back and forth, somatic complaints and rumination. |
|
| Arthralgia | General disorders | CTCAE (3.0) | Systematic Assessment | Joint pain. |
|
| Aspartate aminotransferase (AST) increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased levels of aspartate aminotransferase (AST) |
|
| Back pain | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in the back. |
|
| Chest wall pain | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in chest wall |
|
| Constipation | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Constipation (also known as costiveness or dyschezia) refers to bowel movements that are infrequent or hard to pass. |
|
| Cough | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | A cough is a sudden and often repetitively occurring reflex which helps to clear the large breathing passages from secretions, irritants, foreign particles and microbes. |
|
| Creatinine increased | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Increased levels of creatinine |
|
| Dehydration | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dehydration is the excessive loss of body water |
|
| Depression | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Depression is a mental disorder characterized by episodes of all-encompassing low mood accompanied by low self-esteem and loss of interest or pleasure in normally enjoyable activities. |
|
| Diarrhea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Diarrhea is the condition of having three or more loose or liquid bowel movements per day. |
|
| Dry mouth | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dry mouth is associated a change in the composition of saliva or reduced salivary flow (hyposalivation). |
|
| Dysgeusia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dysgeusia is a distortion of the sense of taste |
|
| Dyspepsia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dyspepsia is a condition of impaired digestion characterized by chronic or recurrent pain in the upper abdomen, upper abdominal fullness and feeling full earlier than expected when eating. |
|
| Dysphagia | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Dysphagia is the medical term for the symptom of difficulty in swallowing. |
|
| Dyspnea | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Dyspnea - shortness of breath. |
|
| Edema (limb) | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Swelling of tissues in the limbs due to the accumulation of fluids. |
|
| Epistaxis | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Nosebleed |
|
| Fatigue | General disorders | CTCAE (3.0) | Systematic Assessment | Fatigue (also called exhaustion, tiredness, lethargy, languidness, languor, lassitude, and listlessness) is a subjective feeling of tiredness which is distinct from weakness, and has a gradual onset. |
|
| Headache | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in the head or neck region. |
|
| Hematuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Hematuria is blood in the urine. |
|
| Hyperglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hyperglycemia, or high blood sugar is a condition in which an excessive amount of glucose circulates in the blood plasma. |
|
| Hyperkalemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hyperkalemia refers to the condition in which the concentration of the electrolyte potassium in the blood is elevated. |
|
| Hypertension | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Elevated blood pressure in the arteries. |
|
| Hypoalbuminemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypoalbuminemia is a medical condition where levels of albumin in blood serum are abnormally low. |
|
| Hypocalcemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypocalcemia is the presence of low serum calcium levels in the blood, usually taken as less than 2.1 mmol/L or 9 mg/dl or an ionized calcium level of less than 1.1 mmol/L or 4.5 mg/dL. |
|
| Hypoglycemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypoglycemia is an abnormally diminished content of glucose in the blood. |
|
| Hypomagnesemia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hypomagnesemia (or hypomagnesaemia) is an electrolyte disturbance in which there is an abnormally low level of magnesium in the blood. |
|
| Hyponatremia | Metabolism and nutrition disorders | CTCAE (3.0) | Systematic Assessment | Hyponatremia - An electrolyte disturbance in which the sodium ion concentration in the serum is lower than normal. |
|
| Hypotension | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Hypotension is low blood pressure. |
|
| Hypothyroidism | Endocrine disorders | CTCAE (3.0) | Systematic Assessment | Hypothyroidism is a state in which the thyroid gland does not produce a sufficient amount of the thyroid hormones thyroxine (T4) and triiodothyronine (T3). |
|
| Insomnia | General disorders | CTCAE (3.0) | Systematic Assessment | Insomnia, or sleeplessness, is a sleep disorder in which there is an inability to fall asleep or to stay asleep as long as desired. |
|
| Lymphocyte count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Low lymphocyte count |
|
| Mucositis (oral) | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Inflammation and ulceration that occurs in the mouth |
|
| Muscle weakness | Musculoskeletal and connective tissue disorders | CTCAE (3.0) | Systematic Assessment | Muscle weakness is a lack of muscle strength. |
|
| Nail loss | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Fingernail loss is a removal of the whole or part of the nail from the bed. |
|
| Nausea | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Nausea a sensation of unease and discomfort in the upper stomach with an involuntary urge to vomit. |
|
| Oral pain | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in the mouth. |
|
| Pain - Other | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in unspecified region. |
|
| Pain in extremity | General disorders | CTCAE (3.0) | Systematic Assessment | Pain in extremity |
|
| Palmar-plantar erythrodysesthesia syndrome | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | Palmar-plantar erythrodysesthesia (hand-foot) syndrome results when a small amount of drug leaks out of the blood vessels, damaging tissues. |
|
| Peripheral sensory neuropathy | Nervous system disorders | CTCAE (3.0) | Systematic Assessment | Inflammation or degeneration of the sensory nerves. |
|
| Pharyngolaryngeal pain | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | A disorder characterized by marked discomfort sensation in the pharyngolaryngeal (pharynx/larynx) region. |
|
| Platelet count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Low platelet count |
|
| Proteinuria | Renal and urinary disorders | CTCAE (3.0) | Systematic Assessment | Proteinuria-also called albuminuria or urine albumin-is a condition in which urine contains an abnormal amount of protein. |
|
| Rash (maculo-papular) | Skin and subcutaneous tissue disorders | CTCAE (3.0) | Systematic Assessment | A maculopapular rash is a type of rash characterized by a flat, red area on the skin that is covered with small confluent bumps. |
|
| Sinus tachycardia | Cardiac disorders | CTCAE (3.0) | Systematic Assessment | Sinus tachycardia is a heart rhythm with elevated rate of impulses originating from the sinoatrial node, defined as a rate greater than 100 beats/min (bpm) in an average adult. |
|
| Voice changes | Respiratory, thoracic and mediastinal disorders | CTCAE (3.0) | Systematic Assessment | Hoarseness, loss or alteration in voice, laryngitis |
|
| Vomiting | Gastrointestinal disorders | CTCAE (3.0) | Systematic Assessment | Vomiting is the forceful expulsion of the contents of one's stomach through the mouth and sometimes the nose. |
|
| Weight loss | General disorders | CTCAE (3.0) | Systematic Assessment | Weight loss is a reduction of the total body mass, due to a mean loss of fluid, body fat or adipose tissue and/or lean mass, namely bone mineral deposits, muscle, tendon and other connective tissue. |
|
| White blood cell count decreased | Blood and lymphatic system disorders | CTCAE (3.0) | Systematic Assessment | Low white blood cell count |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Hedy Kindler | The University of Chicago | (773) 702-0360 | hkindler@medicine.bsd.uchicago.edu |
| ID | Term |
|---|---|
| D000086002 | Mesothelioma, Malignant |
| D054363 | Solitary Fibrous Tumor, Pleural |
| ID | Term |
|---|---|
| D008654 | Mesothelioma |
| D000236 | Adenoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D018301 | Neoplasms, Mesothelial |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D010997 | Pleural Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D054364 | Solitary Fibrous Tumors |
| D018218 | Neoplasms, Fibrous Tissue |
| D009372 | Neoplasms, Connective Tissue |
| D018204 | Neoplasms, Connective and Soft Tissue |
Not provided
Not provided
| ID | Term |
|---|---|
| C500926 | cediranib |
Not provided
Not provided
Not provided