Non-Small Cell Lung Carcinoma Estrogen receptor positive TNM clinical staging | Non-Small Cell Lung Carcinoma Progesterone receptor positive TNM clinical staging
Item
estrogen or progesterone receptor positive stage iiib/iv non-small cell lung cancer
boolean
C0007131 (UMLS CUI [1,1])
C0279754 (UMLS CUI [1,2])
C3258246 (UMLS CUI [1,3])
C0007131 (UMLS CUI [2,1])
C0279759 (UMLS CUI [2,2])
C3258246 (UMLS CUI [2,3])
Erlotinib Dose Approved | Stable Disease
Item
eligible patients will have stable disease on erlotinib monotherapy at fda- approved doses after a minimum duration of erlotinib therapy of 2 months
boolean
C1135135 (UMLS CUI [1,1])
C0178602 (UMLS CUI [1,2])
C0205540 (UMLS CUI [1,3])
C0677946 (UMLS CUI [2])
Age
Item
18 years or older
boolean
C0001779 (UMLS CUI [1])
ECOG performance status
Item
ecog performance status ≤2
boolean
C1520224 (UMLS CUI [1])
Organ function
Item
adequate organ function requirements
boolean
C0678852 (UMLS CUI [1])
Coagulation function measurement
Item
adequate coagulation function
boolean
C3516400 (UMLS CUI [1])
Postmenopausal state | Amenorrhea Duration | Surgical menopause
Item
postmenopausal status in female patients is required and is defined as no menstrual periods for 12 month or surgical menopause
boolean
C0232970 (UMLS CUI [1])
C0002453 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0740421 (UMLS CUI [3])
Informed Consent
Item
all patients must sign a written informed consent.
boolean
C0021430 (UMLS CUI [1])
Pregnancy | Breast Feeding
Item
pregnant or breast-feeding women will not be entered on this study
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational New Drugs
Item
patients who are currently receiving another investigational drugs
boolean
C0013230 (UMLS CUI [1])
Antineoplastic Agents
Item
patients who are currently receiving other anti-cancer agents.
boolean
C0003392 (UMLS CUI [1])
Hormone replacement therapy To be stopped
Item
hormone replacement therapy will not be allowed and have to be stopped 1 month prior to entry into the study
boolean
C0282402 (UMLS CUI [1,1])
C1272691 (UMLS CUI [1,2])
Communicable Disease Uncontrolled
Item
patients who have an uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Erlotinib U/day
Item
patients receiving less than 100mg/day of erlotinib
boolean
C1135135 (UMLS CUI [1,1])
C0456683 (UMLS CUI [1,2])
Erlotinib | Disease Progression
Item
patients with evidence of progression after 2 months of erlotinib monotherapy.
boolean
C1135135 (UMLS CUI [1])
C0242656 (UMLS CUI [2])
Bleeding tendency | Disseminated Intravascular Coagulation | Clotting factor deficiency | Anticoagulant therapy | Exception Antiplatelet therapy
Item
patients with a history of bleeding diathesis (i.e., disseminated intravascular coagulation [dic], clotting factor deficiency) or long-term anticoagulant therapy (other than antiplatelet therapy).
boolean
C1458140 (UMLS CUI [1])
C0012739 (UMLS CUI [2])
C0272315 (UMLS CUI [3])
C0150457 (UMLS CUI [4])
C1705847 (UMLS CUI [5,1])
C1096021 (UMLS CUI [5,2])
Hypersensitivity Fulvestrant Excipient Active | Hypersensitivity Fulvestrant Excipient Inactive | Castor oil allergy | Mannitol allergy
Item
patients with a history of hypersensitivity to active or inactive excipients of fulvestrant (i.e. castor oil or mannitol).
boolean
C0020517 (UMLS CUI [1,1])
C0935916 (UMLS CUI [1,2])
C0015237 (UMLS CUI [1,3])
C0205177 (UMLS CUI [1,4])
C0020517 (UMLS CUI [2,1])
C0935916 (UMLS CUI [2,2])
C0015237 (UMLS CUI [2,3])
C1705605 (UMLS CUI [2,4])
C0571232 (UMLS CUI [3])
C0571922 (UMLS CUI [4])
Safety Monitoring Compliance behavior Limited
Item
patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
boolean
C0036043 (UMLS CUI [1,1])
C1516647 (UMLS CUI [1,2])
C1321605 (UMLS CUI [1,3])
C0439801 (UMLS CUI [1,4])