Non-Small Cell Lung Carcinoma Advanced TNM clinical staging | Chemotherapy cycle Quantity Scheduled | Carboplatin | docetaxel
Item
1. patients must have histologically or cytologically confirmed diagnosed advanced non-small cell lung cancer (stage iiib and iv) and be scheduled to receive four cycles of carboplatin and docetaxel chemotherapy.
boolean
C0007131 (UMLS CUI [1,1])
C0205179 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C1302181 (UMLS CUI [2,1])
C1265611 (UMLS CUI [2,2])
C0205539 (UMLS CUI [2,3])
C0079083 (UMLS CUI [3])
C0246415 (UMLS CUI [4])
Non-Small Cell Lung Carcinoma Newly Diagnosed | Prior Therapy Non-Small Cell Lung Carcinoma | Prior Chemotherapy Non-Small Cell Lung Carcinoma
Item
2. newly diagnosed or previously treated patient with nsclc. previously treated patients are allowed to have any previous chemotherapy for the treatment of nsclc.
boolean
C0007131 (UMLS CUI [1,1])
C1518321 (UMLS CUI [1,2])
C1514463 (UMLS CUI [2,1])
C0007131 (UMLS CUI [2,2])
C1514457 (UMLS CUI [3,1])
C0007131 (UMLS CUI [3,2])
Age
Item
3. age >18 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status | Karnofsky Performance Status
Item
4. ecog performance status < or =2 (karnofsky > or = 60%)
boolean
C1520224 (UMLS CUI [1])
C0206065 (UMLS CUI [2])
Life Expectancy
Item
5. life expectancy of greater than 6 months
boolean
C0023671 (UMLS CUI [1])
Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum bilirubin normal
Item
6. patients must have normal organ and marrow function as defined below: - leukocytes > or = 3,000/mcl - absolute neutrophil count > or = 1,500/mcl - platelets > or = 100,000/mcl - total bilirubin within normal institutional limits -
boolean
C0678852 (UMLS CUI [1])
C0005953 (UMLS CUI [2,1])
C0031843 (UMLS CUI [2,2])
C0023508 (UMLS CUI [3])
C0948762 (UMLS CUI [4])
C0032181 (UMLS CUI [5])
C0428443 (UMLS CUI [6])
Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Serum creatinine normal | Creatinine clearance measurement | Serum creatinine raised
Item
ast(sgot)/alt(sgpt) < or = 2.5 x institutional upper limit of normal - creatinine within normal institutional limits or - creatinine clearance > or = 60 ml/min/1.73 m2 for patients with creatinine levels above institutional normal
boolean
C0201899 (UMLS CUI [1])
C0201836 (UMLS CUI [2])
C0438244 (UMLS CUI [3])
C0373595 (UMLS CUI [4])
C0700225 (UMLS CUI [5])
Childbearing Potential Serum pregnancy test negative | Childbearing Potential Urine pregnancy test negative
Item
7. negative serum or urine pregnancy test in women of child-bearing potential
boolean
C3831118 (UMLS CUI [1,1])
C0430061 (UMLS CUI [1,2])
C3831118 (UMLS CUI [2,1])
C0430057 (UMLS CUI [2,2])
Chemotherapy Scheduled | Carboplatin | docetaxel
Item
8. scheduled to begin carboplatin and docetaxel chemotherapy in the next 30 days
boolean
C0392920 (UMLS CUI [1,1])
C0205539 (UMLS CUI [1,2])
C0079083 (UMLS CUI [2])
C0246415 (UMLS CUI [3])
Anvirzel | Fetus drug adverse effect Unknown | Childbearing Potential Contraceptive methods | Gender Contraceptive methods | Hormonal contraception | Contraception, Barrier | Sexual Abstinence
Item
9. the effects of anvirzel on the developing human fetus are unknown. for this reason, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
boolean
C0967809 (UMLS CUI [1])
C0920518 (UMLS CUI [2,1])
C0439673 (UMLS CUI [2,2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0079399 (UMLS CUI [4,1])
C0700589 (UMLS CUI [4,2])
C2985296 (UMLS CUI [5])
C0004764 (UMLS CUI [6])
C0036899 (UMLS CUI [7])
Informed Consent
Item
10. ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Investigational New Drugs
Item
1. patients receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Allergic Reaction Compound Cardiac Glycosides Similar
Item
2. history of allergic reactions attributed to compounds of similar chemical or biologic composition to cardiac glycosides
boolean
C1527304 (UMLS CUI [1,1])
C1706082 (UMLS CUI [1,2])
C0007158 (UMLS CUI [1,3])
C2348205 (UMLS CUI [1,4])
CYP3A4 Inhibitor | CYP3A4 Inducer
Item
3. patients receiving any medications or substances that are inhibitors or inducers of cyp 3a4 are ineligible
boolean
C3830624 (UMLS CUI [1])
C3830625 (UMLS CUI [2])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
4. uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
boolean
C0009488 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0009450 (UMLS CUI [2])
C0742758 (UMLS CUI [3])
C0002965 (UMLS CUI [4])
C0003811 (UMLS CUI [5])
C0004936 (UMLS CUI [6,1])
C0439801 (UMLS CUI [6,2])
C0525058 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C0439801 (UMLS CUI [7,2])
C0525058 (UMLS CUI [7,3])
Pregnancy | Breast Feeding
Item
5. pregnant or breastfeeding women
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
HIV Seropositivity | Antiretroviral therapy Combined | Drug Interaction potential Anvirzel | Patients At risk Communicable Disease Lethal | Relationship Therapeutic Bone Marrow Suppression
Item
6. hiv-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with anvirzel. in addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy.
boolean
C0019699 (UMLS CUI [1])
C1963724 (UMLS CUI [2,1])
C0205195 (UMLS CUI [2,2])
C0687133 (UMLS CUI [3,1])
C3245505 (UMLS CUI [3,2])
C0967809 (UMLS CUI [3,3])
C0030705 (UMLS CUI [4,1])
C1444641 (UMLS CUI [4,2])
C0009450 (UMLS CUI [4,3])
C3151529 (UMLS CUI [4,4])
C0439849 (UMLS CUI [5,1])
C2698538 (UMLS CUI [5,2])
Cardiovascular Disease Uncontrolled | Cardiovascular Disease Significant | Myocardial Infarction | Angina Pectoris Uncontrolled | Congestive heart failure New York Heart Association Classification | Congestive heart failure Uncontrolled | Congenital long QT syndrome Suspected | Ventricular arrhythmia | Tachycardia, Ventricular | Ventricular Fibrillation | Wolff-Parkinson-White Syndrome | Torsades de Pointes | Prolonged QTc interval on electrocardiogram (ECG) | Second degree atrioventricular block | Complete atrioventricular block | Heart rate | Heart rate Sustained Electrocardiogram | Atrial Fibrillation | ATRIAL FIBRILLATION UNCONTROLLED | Uncontrolled hypertension | Blood Pressure Sustained
Item
7. uncontrolled or significant cardiovascular disease, including: • myocardial infarction within 6 months • uncontrolled angina within 6 months • newly diagnosed congestive heart failure within 6 months, defined as nyhc-ii or currently uncontrolled congestive heart failure • diagnosed or suspected congenital long qt syndrome • any history of clinically significant ventricular arrhythmias (such as ventricular tachycardia, ventricular fibrillation, wolff-parkinson-white (wpw) syndrome, or torsade de pointes). prolonged qtc interval on pre-entry electrocardiogram (> 450 msec). if the automated reading is prolonged (i.e., > 450 msec), the ekg should be manually over-read • any history of second or third degree heart block • heart rate < 50 beats/minute or sustained heart rate > 110 on pre-entry electrocardiogram • newly diagnosed atrial fibrillation within 6 months or currently uncontrolled atrial fibrillation • uncontrolled hypertension defined as sustained blood pressure of >/= 140/90mm hg
boolean
C0007222 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
C0007222 (UMLS CUI [2,1])
C0750502 (UMLS CUI [2,2])
C0027051 (UMLS CUI [3])
C0002962 (UMLS CUI [4,1])
C0205318 (UMLS CUI [4,2])
C0018802 (UMLS CUI [5,1])
C1275491 (UMLS CUI [5,2])
C0018802 (UMLS CUI [6,1])
C0205318 (UMLS CUI [6,2])
C1141890 (UMLS CUI [7,1])
C0750491 (UMLS CUI [7,2])
C0085612 (UMLS CUI [8])
C0042514 (UMLS CUI [9])
C0042510 (UMLS CUI [10])
C0043202 (UMLS CUI [11])
C0040479 (UMLS CUI [12])
C4015677 (UMLS CUI [13])
C0264906 (UMLS CUI [14])
C0151517 (UMLS CUI [15])
C0018810 (UMLS CUI [16])
C0018810 (UMLS CUI [17,1])
C0443318 (UMLS CUI [17,2])
C0013798 (UMLS CUI [17,3])
C0004238 (UMLS CUI [18])
C0741284 (UMLS CUI [19])
C1868885 (UMLS CUI [20])
C0005823 (UMLS CUI [21,1])
C0443318 (UMLS CUI [21,2])
Artificial cardiac pacemaker
Item
8. current use of a pacemaker
boolean
C0030163 (UMLS CUI [1])
Bevacizumab | Bevacizumab Scheduled
Item
9. patients using or scheduled to use bevacizumab during study period
boolean
C0796392 (UMLS CUI [1])
C0796392 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
Cardiac Glycoside
Item
10. current use of cardiac glycoside
boolean
C0007158 (UMLS CUI [1])