Age
Item
age >= 18 years old
boolean
C0001779 (UMLS CUI [1])
Malignant Neoplasm Amenable Biopsy | Biopsy Willing
Item
tumor accessible for biopsy and willingness to undergo baseline and 1 post treatment biopsy
boolean
C0006826 (UMLS CUI [1,1])
C3900053 (UMLS CUI [1,2])
C0005558 (UMLS CUI [1,3])
C0005558 (UMLS CUI [2,1])
C0600109 (UMLS CUI [2,2])
Carcinoma breast stage IV | Malignant neoplasm of breast Inoperable | Malignant neoplasm of colon stage IV | Malignant tumor of colon Inoperable | Metastatic melanoma | melanoma Inoperable | Prior Therapy | Cytotoxic Chemotherapy Quantity Metastatic Neoplasm | Cytotoxic Chemotherapy melanoma | Therapeutic radiology procedure Measurable Disease
Item
biopsiable, histologically or cytologically confirmed metastatic or inoperable breast cancer, colon cancer, or melanoma. prior treatment requirement : i) no more than 2 prior cytotoxic chemotherapy regimens for metastatic disease for patients with breast or colon cancers; ii) no prio cytotoxic therapy for patients with melanoma, or iii) measurable lesion (s) that have not been irradiated.
boolean
C0278488 (UMLS CUI [1])
C0006142 (UMLS CUI [2,1])
C0205187 (UMLS CUI [2,2])
C0278484 (UMLS CUI [3])
C0007102 (UMLS CUI [4,1])
C0205187 (UMLS CUI [4,2])
C0278883 (UMLS CUI [5])
C0025202 (UMLS CUI [6,1])
C0205187 (UMLS CUI [6,2])
C1514463 (UMLS CUI [7])
C0677881 (UMLS CUI [8,1])
C1265611 (UMLS CUI [8,2])
C2939420 (UMLS CUI [8,3])
C0677881 (UMLS CUI [9,1])
C0025202 (UMLS CUI [9,2])
C1522449 (UMLS CUI [10,1])
C1513041 (UMLS CUI [10,2])
Renal function | Liver function | Bone Marrow function | Creatinine measurement, serum | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Liver Involvement | Absolute neutrophil count | Platelet Count measurement
Item
adequate renal, liver, and bone marrow function, determined within 2 weeks prior to the first treatment, defined as the following: serum creatinine <1.5 x uln, total bilirubin <2 x uln, aspartate aminotransferase (ast) or alanine aminotransferase (alt) <3 x uln (<5 x uln for patients with liver involvement); absolute neutrophil count (anc) >1500/ul; and platelet >100,000/ul
boolean
C0232804 (UMLS CUI [1])
C0232741 (UMLS CUI [2])
C0005953 (UMLS CUI [3,1])
C0031843 (UMLS CUI [3,2])
C0201976 (UMLS CUI [4])
C1278039 (UMLS CUI [5])
C0201899 (UMLS CUI [6])
C0201836 (UMLS CUI [7])
C0023884 (UMLS CUI [8,1])
C1314939 (UMLS CUI [8,2])
C0948762 (UMLS CUI [9])
C0032181 (UMLS CUI [10])
Hemoglobin | Blood Transfusion | Erythropoietin
Item
hemoglobin >9.0 g/dl. treatment with transfusions or erythropoietin to elevate the hemoglobin level for eligibility purposes is not permitted. patients must have discontinued erythropoietin at least 2 weeks prior to the first dose of study medication
boolean
C0019046 (UMLS CUI [1])
C0005841 (UMLS CUI [2])
C0014822 (UMLS CUI [3])
Serum calcium measurement | Phosphorus measurement
Item
serum calcium <1 x uln and phosphorus <1 x uln
boolean
C0728876 (UMLS CUI [1])
C0202178 (UMLS CUI [2])
Fertility Contraceptive methods | Pregnancy | Breast Feeding
Item
patients having reproductive potential must use adequate method of birth control. patients may not be pregnant or breastfeeding.
boolean
C0015895 (UMLS CUI [1,1])
C0700589 (UMLS CUI [1,2])
C0032961 (UMLS CUI [2])
C0006147 (UMLS CUI [3])
ECOG performance status
Item
ecog status of 0,1, or 2.
boolean
C1520224 (UMLS CUI [1])
Able to swallow Investigational New Drugs | Gastrointestinal Diseases Affecting drug absorption
Item
must be able to swallow intact study medication and have no gastrointestinal disorders that may affect absorption of the drug
boolean
C2712086 (UMLS CUI [1,1])
C0013230 (UMLS CUI [1,2])
C0017178 (UMLS CUI [2,1])
C0392760 (UMLS CUI [2,2])
C0678745 (UMLS CUI [2,3])
Protocol Compliance | Caregiver Administration of medication
Item
must be able to follow instructions or protocol specified procedures, or have a daily care giver who will be responsible for administering study medication.
boolean
C0525058 (UMLS CUI [1])
C0085537 (UMLS CUI [2,1])
C3469597 (UMLS CUI [2,2])
Informed Consent
Item
must be able to give written informed consent.
boolean
C0021430 (UMLS CUI [1])
Parathyroid Diseases | Hypercalcemia Associated with Malignant Neoplasms
Item
no parathyroid disorder or history of malignancy associated hypercalcemia
boolean
C0030517 (UMLS CUI [1])
C0020437 (UMLS CUI [2,1])
C0332281 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Therapeutic radiology procedure | Cytotoxic Chemotherapy | Immunotherapy | Biological treatment | Hormone Therapy | Molecular Targeted Therapy
Item
no ongoing radiation therapy or radio-cytotoxic therapy within prior 4 weeks; no immunotherapy, biologic therapy, hormonal, or molecular targeted therapy within prior 2 weeks
boolean
C1522449 (UMLS CUI [1])
C0677881 (UMLS CUI [2])
C0021083 (UMLS CUI [3])
C1531518 (UMLS CUI [4])
C0279025 (UMLS CUI [5])
C2699893 (UMLS CUI [6])
Communicable Disease Serious | Life threatening illness Relationship Malignant Neoplasm
Item
no concurrent serious infection or life-threatening illness (unrelated to tumor)
boolean
C0009450 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C3846017 (UMLS CUI [2,1])
C0439849 (UMLS CUI [2,2])
C0006826 (UMLS CUI [2,3])
Malignant Neoplasms | Skin carcinoma | Carcinoma in situ of uterine cervix | Disease In complete remission
Item
no history of any cancer other than the present condition (except nonmelanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission and off all therapy for that disease for a minimum of 3 years
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2])
C0851140 (UMLS CUI [3])
C0012634 (UMLS CUI [4,1])
C0677874 (UMLS CUI [4,2])
Metastatic malignant neoplasm to brain untreated
Item
no untreated brain metastases.
boolean
C0220650 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])