English

Eligibility Non-Small Cell Lung Cancer NCT00870532

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients must have histologically or cytologically confirmed nsclc
Description

Non-Small Cell Lung Carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0007131
2. at least one or 2 prior lines of chemotherapy, including oral egfr tyrosine-kinase inhibitor for metastatic disease or locally advanced unresectable disease. there should be at least 4 weeks since prior chemotherapy or radiation therapy; patients who decline conventional chemotherapy or oral egfr tyrosine-kinase inhibitor as salvage 2nd or 3rd line treatment are also eligible.
Description

Line of Chemotherapy Quantity | Epidermal growth factor receptor inhibitor Oral | Neoplasm Metastasis | Disease unresectable Advanced Locally | Prior Chemotherapy | Prior radiation therapy

Data type

boolean

Alias
UMLS CUI [1,1]
C4524693
UMLS CUI [1,2]
C0392920
UMLS CUI [1,3]
C1265611
UMLS CUI [2,1]
C1443775
UMLS CUI [2,2]
C1527415
UMLS CUI [3]
C0027627
UMLS CUI [4,1]
C0012634
UMLS CUI [4,2]
C1519810
UMLS CUI [4,3]
C0205179
UMLS CUI [4,4]
C1517927
UMLS CUI [5]
C1514457
UMLS CUI [6]
C0279134
3. minimum body-surface area (bsa) of 1.4 m2 at point of recruitment. this is a safeguard against recruiting small-built patients who may experience adverse reaction on absolute dosing of oral vinorelbine. at this body surface area, the maximum dosing of oral vinorelbine at 120 mg/week is equivalent to 86 mg/m2/week for a patient with bsa of 1.4 m2.
Description

Body Surface Area Minimum | Adverse reactions Vinorelbine Oral Dose | Vinorelbine Oral Dose Maximum

Data type

boolean

Alias
UMLS CUI [1,1]
C0005902
UMLS CUI [1,2]
C1524031
UMLS CUI [2,1]
C0559546
UMLS CUI [2,2]
C0078257
UMLS CUI [2,3]
C1527415
UMLS CUI [2,4]
C0178602
UMLS CUI [3,1]
C0078257
UMLS CUI [3,2]
C1527415
UMLS CUI [3,3]
C0178602
UMLS CUI [3,4]
C0806909
4. age >21 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
5. ecog performance status <2 (karnofsky >60%)
Description

ECOG performance status

Data type

boolean

Alias
UMLS CUI [1]
C1520224
6. patients must have normal organ and marrow function as defined here: leukocytes >3,000/mcl, absolute neutrophil count >1,500/mcl, platelet count > 100,000/mcl, serum bilirubin within normal institutional limits, ast(sgot)/alt(sgpt) <2.5 x upper limit of normal, and creatinine within normal institutional limits or creatinine clearance >60 ml/min/1.73 m2 for patients. these tests must be done within 1 week of study treatment.
Description

Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement

Data type

boolean

Alias
UMLS CUI [1]
C0678852
UMLS CUI [2,1]
C0005953
UMLS CUI [2,2]
C0031843
UMLS CUI [3]
C0023508
UMLS CUI [4]
C0948762
UMLS CUI [5]
C0032181
UMLS CUI [6]
C1278039
UMLS CUI [7]
C0201899
UMLS CUI [8]
C0201836
UMLS CUI [9]
C0201976
UMLS CUI [10]
C0373595
7. ability to understand and the willingness to sign a written informed consent document
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
Description

Chemotherapy | Therapeutic radiology procedure | Adverse event Due to Pharmaceutical Preparations | Recovery Lacking

Data type

boolean

Alias
UMLS CUI [1]
C0392920
UMLS CUI [2]
C1522449
UMLS CUI [3,1]
C0877248
UMLS CUI [3,2]
C0678226
UMLS CUI [3,3]
C0013227
UMLS CUI [4,1]
C2004454
UMLS CUI [4,2]
C0332268
2. patients receiving any other investigational agents
Description

Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1]
C0013230
3. patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
Description

Metastatic malignant neoplasm to brain | Prognosis bad | Progressive neurologic dysfunction Interferes with Evaluation Adverse event

Data type

boolean

Alias
UMLS CUI [1]
C0220650
UMLS CUI [2]
C0278252
UMLS CUI [3,1]
C4013375
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [3,4]
C0877248
4. history of allergic reactions attributed to compounds of similar chemical or biologic composition to oral vinorelbine or other agents used in study
Description

Allergic Reaction Vinorelbine Oral | Allergic Reaction Investigational New Drugs | Etiology Compound Chemical composition Similar | Etiology Compound Composition biological Similar

Data type

boolean

Alias
UMLS CUI [1,1]
C1527304
UMLS CUI [1,2]
C0078257
UMLS CUI [1,3]
C1527415
UMLS CUI [2,1]
C1527304
UMLS CUI [2,2]
C0013230
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C1706082
UMLS CUI [3,3]
C0243176
UMLS CUI [3,4]
C2348205
UMLS CUI [4,1]
C0015127
UMLS CUI [4,2]
C1706082
UMLS CUI [4,3]
C0486616
UMLS CUI [4,4]
C0205460
UMLS CUI [4,5]
C2348205
5. prior and / or concomitant treatment with drugs known to induce or inhibit cytochrome p450 3a4: phenytoin, carbamazepine, barbiturates, rifampicin, imidazole antifungals (such as ketoconazole, fluconazole, itraconazole, metronidazole), omeprazole and ritonavir. patients who are taking gastric acid-lowering agents such as h2 antagonist or antacids will be evaluated regarding the need to continue with these medications. if discontinuation of these medications is medically contraindicated, the patient will be excluded as these agents are known to lower the solubility of sorafenib and hence may limit their efficacy.
Description

CYP3A4 Inducers | CYP3A4 Inhibitors | Phenytoin | Carbamazepine | Barbiturates | Rifampin | Imidazole Antifungals | Ketoconazole | Fluconazole | Itraconazole | Metronidazole | Omeprazole | Ritonavir | Pharmaceutical Preparations Gastric Acid Lowering allowed | H2 Antagonists allowed | Antacids allowed

Data type

boolean

Alias
UMLS CUI [1]
C3850041
UMLS CUI [2]
C3850053
UMLS CUI [3]
C0031507
UMLS CUI [4]
C0006949
UMLS CUI [5]
C0004745
UMLS CUI [6]
C0035608
UMLS CUI [7,1]
C0020923
UMLS CUI [7,2]
C0003308
UMLS CUI [8]
C0022625
UMLS CUI [9]
C0016277
UMLS CUI [10]
C0064113
UMLS CUI [11]
C0025872
UMLS CUI [12]
C0028978
UMLS CUI [13]
C0292818
UMLS CUI [14,1]
C0013227
UMLS CUI [14,2]
C0017119
UMLS CUI [14,3]
C2003888
UMLS CUI [14,4]
C0683607
UMLS CUI [15,1]
C0019593
UMLS CUI [15,2]
C0683607
UMLS CUI [16,1]
C0003138
UMLS CUI [16,2]
C0683607
6. significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
Description

Malabsorption Syndrome | Disease Affecting Gastrointestinal function

Data type

boolean

Alias
UMLS CUI [1]
C0024523
UMLS CUI [2,1]
C0012634
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0516983
7. significant peripheral or autonomic neuropathy affecting sensation or bowel motility
Description

Peripheral Neuropathy Affecting Sensation | Autonomic neuropathy Affecting Sensation | Peripheral Neuropathy Affecting Intestinal Motility | Autonomic neuropathy Affecting Intestinal Motility

Data type

boolean

Alias
UMLS CUI [1,1]
C0031117
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C0036658
UMLS CUI [2,1]
C0259749
UMLS CUI [2,2]
C0392760
UMLS CUI [2,3]
C0036658
UMLS CUI [3,1]
C0031117
UMLS CUI [3,2]
C0392760
UMLS CUI [3,3]
C0021838
UMLS CUI [4,1]
C0259749
UMLS CUI [4,2]
C0392760
UMLS CUI [4,3]
C0021838
8. 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
Description

Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0205318
UMLS CUI [2]
C0009450
UMLS CUI [3]
C0742758
UMLS CUI [4]
C0002965
UMLS CUI [5]
C0003811
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0439801
UMLS CUI [6,3]
C0525058
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C0439801
UMLS CUI [7,3]
C0525058
9. uncontrolled hypertension defined as systolic blood pressure >150 mmhg or diastolic pressure >90 mmhg despite optimal management
Description

Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1]
C1868885
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
10. pregnancy or breast-feeding or women of childbearing potential not using effective contraception
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C0332197
11. evidence or history of bleeding diathesis or coagulopathy
Description

Bleeding tendency | Blood Coagulation Disorders

Data type

boolean

Alias
UMLS CUI [1]
C1458140
UMLS CUI [2]
C0005779
12. thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
Description

Thrombosis | Embolism | Cerebrovascular accident | Transient Ischemic Attack

Data type

boolean

Alias
UMLS CUI [1]
C0040053
UMLS CUI [2]
C0013922
UMLS CUI [3]
C0038454
UMLS CUI [4]
C0007787
13. pulmonary hemorrhage/bleeding event >ctcae grade 2 within 4 weeks of recruitment
Description

Pulmonary hemorrhage CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0151701
UMLS CUI [1,2]
C1516728
14. any other hemorrhage/bleeding event >ctcae grade 3 within 4 weeks of recruitment
Description

Hemorrhage CTCAE Grades

Data type

boolean

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C1516728
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Similar models

Eligibility Non-Small Cell Lung Cancer NCT00870532

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Small Cell Lung Carcinoma
Item
1. patients must have histologically or cytologically confirmed nsclc
boolean
C0007131 (UMLS CUI [1])
Line of Chemotherapy Quantity | Epidermal growth factor receptor inhibitor Oral | Neoplasm Metastasis | Disease unresectable Advanced Locally | Prior Chemotherapy | Prior radiation therapy
Item
2. at least one or 2 prior lines of chemotherapy, including oral egfr tyrosine-kinase inhibitor for metastatic disease or locally advanced unresectable disease. there should be at least 4 weeks since prior chemotherapy or radiation therapy; patients who decline conventional chemotherapy or oral egfr tyrosine-kinase inhibitor as salvage 2nd or 3rd line treatment are also eligible.
boolean
C4524693 (UMLS CUI [1,1])
C0392920 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C1443775 (UMLS CUI [2,1])
C1527415 (UMLS CUI [2,2])
C0027627 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C1519810 (UMLS CUI [4,2])
C0205179 (UMLS CUI [4,3])
C1517927 (UMLS CUI [4,4])
C1514457 (UMLS CUI [5])
C0279134 (UMLS CUI [6])
Body Surface Area Minimum | Adverse reactions Vinorelbine Oral Dose | Vinorelbine Oral Dose Maximum
Item
3. minimum body-surface area (bsa) of 1.4 m2 at point of recruitment. this is a safeguard against recruiting small-built patients who may experience adverse reaction on absolute dosing of oral vinorelbine. at this body surface area, the maximum dosing of oral vinorelbine at 120 mg/week is equivalent to 86 mg/m2/week for a patient with bsa of 1.4 m2.
boolean
C0005902 (UMLS CUI [1,1])
C1524031 (UMLS CUI [1,2])
C0559546 (UMLS CUI [2,1])
C0078257 (UMLS CUI [2,2])
C1527415 (UMLS CUI [2,3])
C0178602 (UMLS CUI [2,4])
C0078257 (UMLS CUI [3,1])
C1527415 (UMLS CUI [3,2])
C0178602 (UMLS CUI [3,3])
C0806909 (UMLS CUI [3,4])
Age
Item
4. age >21 years
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
5. ecog performance status <2 (karnofsky >60%)
boolean
C1520224 (UMLS CUI [1])
Organ function | Bone Marrow function | White Blood Cell Count procedure | Absolute neutrophil count | Platelet Count measurement | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Creatinine measurement, serum | Creatinine clearance measurement
Item
6. patients must have normal organ and marrow function as defined here: leukocytes >3,000/mcl, absolute neutrophil count >1,500/mcl, platelet count > 100,000/mcl, serum bilirubin within normal institutional limits, ast(sgot)/alt(sgpt) <2.5 x upper limit of normal, and creatinine within normal institutional limits or creatinine clearance >60 ml/min/1.73 m2 for patients. these tests must be done within 1 week of study treatment.
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])
C1278039 (UMLS CUI [6])
C0201899 (UMLS CUI [7])
C0201836 (UMLS CUI [8])
C0201976 (UMLS CUI [9])
C0373595 (UMLS CUI [10])
Informed Consent
Item
7. ability to understand and the willingness to sign a written informed consent document
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Chemotherapy | Therapeutic radiology procedure | Adverse event Due to Pharmaceutical Preparations | Recovery Lacking
Item
1. patients who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier
boolean
C0392920 (UMLS CUI [1])
C1522449 (UMLS CUI [2])
C0877248 (UMLS CUI [3,1])
C0678226 (UMLS CUI [3,2])
C0013227 (UMLS CUI [3,3])
C2004454 (UMLS CUI [4,1])
C0332268 (UMLS CUI [4,2])
Investigational New Drugs
Item
2. patients receiving any other investigational agents
boolean
C0013230 (UMLS CUI [1])
Metastatic malignant neoplasm to brain | Prognosis bad | Progressive neurologic dysfunction Interferes with Evaluation Adverse event
Item
3. patients with known brain metastases should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events
boolean
C0220650 (UMLS CUI [1])
C0278252 (UMLS CUI [2])
C4013375 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0877248 (UMLS CUI [3,4])
Allergic Reaction Vinorelbine Oral | Allergic Reaction Investigational New Drugs | Etiology Compound Chemical composition Similar | Etiology Compound Composition biological Similar
Item
4. history of allergic reactions attributed to compounds of similar chemical or biologic composition to oral vinorelbine or other agents used in study
boolean
C1527304 (UMLS CUI [1,1])
C0078257 (UMLS CUI [1,2])
C1527415 (UMLS CUI [1,3])
C1527304 (UMLS CUI [2,1])
C0013230 (UMLS CUI [2,2])
C0015127 (UMLS CUI [3,1])
C1706082 (UMLS CUI [3,2])
C0243176 (UMLS CUI [3,3])
C2348205 (UMLS CUI [3,4])
C0015127 (UMLS CUI [4,1])
C1706082 (UMLS CUI [4,2])
C0486616 (UMLS CUI [4,3])
C0205460 (UMLS CUI [4,4])
C2348205 (UMLS CUI [4,5])
CYP3A4 Inducers | CYP3A4 Inhibitors | Phenytoin | Carbamazepine | Barbiturates | Rifampin | Imidazole Antifungals | Ketoconazole | Fluconazole | Itraconazole | Metronidazole | Omeprazole | Ritonavir | Pharmaceutical Preparations Gastric Acid Lowering allowed | H2 Antagonists allowed | Antacids allowed
Item
5. prior and / or concomitant treatment with drugs known to induce or inhibit cytochrome p450 3a4: phenytoin, carbamazepine, barbiturates, rifampicin, imidazole antifungals (such as ketoconazole, fluconazole, itraconazole, metronidazole), omeprazole and ritonavir. patients who are taking gastric acid-lowering agents such as h2 antagonist or antacids will be evaluated regarding the need to continue with these medications. if discontinuation of these medications is medically contraindicated, the patient will be excluded as these agents are known to lower the solubility of sorafenib and hence may limit their efficacy.
boolean
C3850041 (UMLS CUI [1])
C3850053 (UMLS CUI [2])
C0031507 (UMLS CUI [3])
C0006949 (UMLS CUI [4])
C0004745 (UMLS CUI [5])
C0035608 (UMLS CUI [6])
C0020923 (UMLS CUI [7,1])
C0003308 (UMLS CUI [7,2])
C0022625 (UMLS CUI [8])
C0016277 (UMLS CUI [9])
C0064113 (UMLS CUI [10])
C0025872 (UMLS CUI [11])
C0028978 (UMLS CUI [12])
C0292818 (UMLS CUI [13])
C0013227 (UMLS CUI [14,1])
C0017119 (UMLS CUI [14,2])
C2003888 (UMLS CUI [14,3])
C0683607 (UMLS CUI [14,4])
C0019593 (UMLS CUI [15,1])
C0683607 (UMLS CUI [15,2])
C0003138 (UMLS CUI [16,1])
C0683607 (UMLS CUI [16,2])
Malabsorption Syndrome | Disease Affecting Gastrointestinal function
Item
6. significant malabsorption syndrome or disease affecting the gastro-intestinal tract function
boolean
C0024523 (UMLS CUI [1])
C0012634 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0516983 (UMLS CUI [2,3])
Peripheral Neuropathy Affecting Sensation | Autonomic neuropathy Affecting Sensation | Peripheral Neuropathy Affecting Intestinal Motility | Autonomic neuropathy Affecting Intestinal Motility
Item
7. significant peripheral or autonomic neuropathy affecting sensation or bowel motility
boolean
C0031117 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])
C0259749 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0036658 (UMLS CUI [2,3])
C0031117 (UMLS CUI [3,1])
C0392760 (UMLS CUI [3,2])
C0021838 (UMLS CUI [3,3])
C0259749 (UMLS CUI [4,1])
C0392760 (UMLS CUI [4,2])
C0021838 (UMLS CUI [4,3])
Comorbidity Uncontrolled | Communicable Disease | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia | Mental disorders Limiting Protocol Compliance | Social situation Limiting Protocol Compliance
Item
8. 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])
Uncontrolled hypertension | Systolic Pressure | Diastolic blood pressure
Item
9. uncontrolled hypertension defined as systolic blood pressure >150 mmhg or diastolic pressure >90 mmhg despite optimal management
boolean
C1868885 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Absent
Item
10. pregnancy or breast-feeding or women of childbearing potential not using effective contraception
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C0332197 (UMLS CUI [3,3])
Bleeding tendency | Blood Coagulation Disorders
Item
11. evidence or history of bleeding diathesis or coagulopathy
boolean
C1458140 (UMLS CUI [1])
C0005779 (UMLS CUI [2])
Thrombosis | Embolism | Cerebrovascular accident | Transient Ischemic Attack
Item
12. thrombotic or embolic events such as cerebrovascular accident including transient ischemic attacks within the past 6 months
boolean
C0040053 (UMLS CUI [1])
C0013922 (UMLS CUI [2])
C0038454 (UMLS CUI [3])
C0007787 (UMLS CUI [4])
Pulmonary hemorrhage CTCAE Grades
Item
13. pulmonary hemorrhage/bleeding event >ctcae grade 2 within 4 weeks of recruitment
boolean
C0151701 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
Hemorrhage CTCAE Grades
Item
14. any other hemorrhage/bleeding event >ctcae grade 3 within 4 weeks of recruitment
boolean
C0019080 (UMLS CUI [1,1])
C1516728 (UMLS CUI [1,2])
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