ID

31333

Description

Study of Ramucirumab in Ovarian Cancer; ODM derived from: https://clinicaltrials.gov/show/NCT00721162

Lien

https://clinicaltrials.gov/show/NCT00721162

Mots-clés

Versions (1)
  1. 14/08/2018 14/08/2018 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

14 août 2018

DOI

Pour une demande vous connecter.

Licence

Creative Commons BY 4.0
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    Eligibility Ovarian Cancer NCT00721162

    Anglais

    Eligibility Ovarian Cancer NCT00721162

    1 Formulaires  
    Inclusion Criteria
    Description

    Inclusion Criteria

    Alias
    UMLS CUI
    C1512693
    each participant must meet the following criteria to be enrolled in this study:
    Description

    Criteria Fulfill

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0243161
    UMLS CUI [1,2]
    C1550543
    1. the participant has recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. histologic documentation of the original primary tumor is required via a pathology report
    Description

    Epithelial ovarian cancer Recurrent | Epithelial ovarian cancer Persistent | Recurrent Fallopian Tube Carcinoma | Fallopian Tube Carcinoma Persistent | Recurrent Primary Peritoneal Carcinoma | Primary peritoneal carcinoma Persistent | Primary tumor Documented Histologic

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0677886
    UMLS CUI [1,2]
    C2945760
    UMLS CUI [2,1]
    C0677886
    UMLS CUI [2,2]
    C0205322
    UMLS CUI [3]
    C3897738
    UMLS CUI [4,1]
    C0238122
    UMLS CUI [4,2]
    C0205322
    UMLS CUI [5]
    C3897731
    UMLS CUI [6,1]
    C1514428
    UMLS CUI [6,2]
    C0205322
    UMLS CUI [7,1]
    C0677930
    UMLS CUI [7,2]
    C1301725
    UMLS CUI [7,3]
    C0205462
    2. the participant has at least one unidimensional-measurable target lesion [≥ 2 centimeter (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography (ct) or magnetic resonance imaging (mri)], as defined by response evaluation criteria in solid tumors (recist). tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
    Description

    Measurable lesion Linear Quantity | Target Lesion Identification Measurement conventional | Target Lesion Identification Spiral CT | Target Lesion Identification MRI

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1513041
    UMLS CUI [1,2]
    C0205132
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [2,1]
    C2986546
    UMLS CUI [2,2]
    C0242485
    UMLS CUI [2,3]
    C0439858
    UMLS CUI [3,1]
    C2986546
    UMLS CUI [3,2]
    C0860888
    UMLS CUI [4,1]
    C2986546
    UMLS CUI [4,2]
    C0024485
    3. the participant has recovered to grade ≤ 1 by the national cancer institute common terminology criteria for adverse events, version 3.0 (nci-ctcae v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to grade ≤ 2). any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to the first dose of study medication, or hormonal therapy discontinued at least one week prior to the first dose of study medication. continuation of hormone replacement therapy is permitted
    Description

    Effects of Therapeutic procedure Patient recovered CTCAE Grades | Operative Surgical Procedures Ovarian Carcinoma | Therapeutic radiology procedure Ovarian Carcinoma | Chemotherapy Ovarian Carcinoma | Hormone Therapy Ovarian Carcinoma | Targeted Therapy Ovarian Carcinoma | Exception Alopecia | Exception Peripheral Neuropathy CTCAE Grades | Prior Therapy Malignant Neoplasms To be stopped | Hormone Therapy To be stopped | Hormone replacement therapy Continuous allowed

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1704420
    UMLS CUI [1,2]
    C0087111
    UMLS CUI [1,3]
    C1115804
    UMLS CUI [1,4]
    C1516728
    UMLS CUI [2,1]
    C0543467
    UMLS CUI [2,2]
    C0029925
    UMLS CUI [3,1]
    C1522449
    UMLS CUI [3,2]
    C0029925
    UMLS CUI [4,1]
    C0392920
    UMLS CUI [4,2]
    C0029925
    UMLS CUI [5,1]
    C0279025
    UMLS CUI [5,2]
    C0029925
    UMLS CUI [6,1]
    C2985566
    UMLS CUI [6,2]
    C0029925
    UMLS CUI [7,1]
    C1705847
    UMLS CUI [7,2]
    C0002170
    UMLS CUI [8,1]
    C1705847
    UMLS CUI [8,2]
    C0031117
    UMLS CUI [8,3]
    C1516728
    UMLS CUI [9,1]
    C1514463
    UMLS CUI [9,2]
    C0006826
    UMLS CUI [9,3]
    C1272691
    UMLS CUI [10,1]
    C0279025
    UMLS CUI [10,2]
    C1272691
    UMLS CUI [11,1]
    C0282402
    UMLS CUI [11,2]
    C0549178
    UMLS CUI [11,3]
    C0683607
    4. the participant has completed at least one platinum-based chemotherapeutic regimen for management of primary disease, and must have at least one of the following: a platinum-free interval of < 12 months after the final dose of primary platinum-based therapy, progression during platinum-based therapy, or persistent disease after platinum-based therapy
    Description

    Chemotherapy Regimen Platinum-Based Quantity | Primary disorder Management | Interval Free of Platinum | Disease Progression | Persistent Disease

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0392920
    UMLS CUI [1,2]
    C1514162
    UMLS CUI [1,3]
    C1265611
    UMLS CUI [2,1]
    C0277554
    UMLS CUI [2,2]
    C0376636
    UMLS CUI [3,1]
    C1272706
    UMLS CUI [3,2]
    C0332296
    UMLS CUI [3,3]
    C0032207
    UMLS CUI [4]
    C0242656
    UMLS CUI [5]
    C2983415
    5. the participant has an eastern cooperative oncology group performance status (ecog ps) of 0-1 at study entry
    Description

    ECOG performance status

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C1520224
    6. the participant has adequate hematological functions [absolute neutrophil count (anc)
    Description

    Hematologic function | Absolute neutrophil count

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0221130
    UMLS CUI [2]
    C0948762
    ≥ 1200 cells/microliter (ul), hemoglobin ≥ 9 grams/deciliter (g/dl), and platelets ≥
    Description

    Hemoglobin measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0518015
    100,000 cells/ul]
    Description

    Platelet Count measurement

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0032181
    7. the participant has adequate hepatic function [bilirubin ≤ 1.5 times the upper limit of normal (uln); aspartate transaminase (ast) and/or alanine transaminase (alt) ≤ 3.0 times uln, or ≤ 5.0 times uln if the transaminase elevation is due to liver metastases]
    Description

    Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Transaminases increased Due to Secondary malignant neoplasm of liver

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0232741
    UMLS CUI [2]
    C1278039
    UMLS CUI [3]
    C0201899
    UMLS CUI [4]
    C0201836
    UMLS CUI [5,1]
    C0438717
    UMLS CUI [5,2]
    C0678226
    UMLS CUI [5,3]
    C0494165
    8. the participant has adequate renal function [serum creatinine ≤ 1.5 x uln or creatinine clearance (measured or calculated) ≥ 60 milliliters/minute (ml/min)]
    Description

    Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0232804
    UMLS CUI [2]
    C0201976
    UMLS CUI [3]
    C0373595
    UMLS CUI [4]
    C2711451
    9. the participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (ua). if urine dipstick or routine analysis indicated ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study
    Description

    Proteinuria Dipstick test | Proteinuria Urinalysis | 24 hour urine sample

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0033687
    UMLS CUI [1,2]
    C0430370
    UMLS CUI [2,1]
    C0033687
    UMLS CUI [2,2]
    C0042014
    UMLS CUI [3]
    C0456209
    10. the participant has adequate coagulation function, as defined by international normalized ratio (inr) ≤ 1.5 and a partial thromboplastin time (ptt) ≤ 1.5 x uln if not receiving anticoagulation therapy. participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic inr and have no active bleeding (defined as within 14 days of first dose of study medication) or pathological condition that carries a high risk of bleeding (example, tumor involving major vessels or known varices)
    Description

    Coagulation function analysis | International Normalized Ratio | Partial Thromboplastin Time measurement | Anticoagulation Therapy Absent | Anticoagulation Therapy Dose Full | Oral anticoagulants Dose Stable | Low-Molecular-Weight Heparin Dose Stable | Warfarin | INR Therapeutic | Hemorrhage Absent | Medical condition High risk of bleeding | Neoplasm Involving Blood Vessel Major | Varices

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C3516400
    UMLS CUI [2]
    C0525032
    UMLS CUI [3]
    C0030605
    UMLS CUI [4,1]
    C0003281
    UMLS CUI [4,2]
    C0332197
    UMLS CUI [5,1]
    C0003281
    UMLS CUI [5,2]
    C0178602
    UMLS CUI [5,3]
    C0443225
    UMLS CUI [6,1]
    C0354604
    UMLS CUI [6,2]
    C0178602
    UMLS CUI [6,3]
    C0205360
    UMLS CUI [7,1]
    C0019139
    UMLS CUI [7,2]
    C0178602
    UMLS CUI [7,3]
    C0205360
    UMLS CUI [8]
    C0043031
    UMLS CUI [9,1]
    C0525032
    UMLS CUI [9,2]
    C0302350
    UMLS CUI [10,1]
    C0019080
    UMLS CUI [10,2]
    C0332197
    UMLS CUI [11,1]
    C3843040
    UMLS CUI [11,2]
    C4039184
    UMLS CUI [12,1]
    C0027651
    UMLS CUI [12,2]
    C1314939
    UMLS CUI [12,3]
    C0005847
    UMLS CUI [12,4]
    C0205164
    UMLS CUI [13]
    C0042345
    11. for participants who have received anthracycline therapy, the left ventricular ejection fraction (lvef) must be within normal institutional range by a pretreatment echocardiogram or multigated acquisition (muga) scan
    Description

    Anthracyclines | Left ventricular ejection fraction Normal Echocardiography pre treatment | Left ventricular ejection fraction Normal MUGA scan pre treatment

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0282564
    UMLS CUI [2,1]
    C0428772
    UMLS CUI [2,2]
    C0205307
    UMLS CUI [2,3]
    C0013516
    UMLS CUI [2,4]
    C2709094
    UMLS CUI [3,1]
    C0428772
    UMLS CUI [3,2]
    C0205307
    UMLS CUI [3,3]
    C0521317
    UMLS CUI [3,4]
    C2709094
    12. if sexually active, the participant is post-menopausal, surgically sterile, or using effective contraception in the opinion of the investigator
    Description

    Sexually active Postmenopausal state | Sexually active Female Sterilization | Sexually active Contraceptive methods

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0241028
    UMLS CUI [1,2]
    C0232970
    UMLS CUI [2,1]
    C0241028
    UMLS CUI [2,2]
    C0015787
    UMLS CUI [3,1]
    C0241028
    UMLS CUI [3,2]
    C0700589
    13. the participant is ≥ 18 years of age
    Description

    Age

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0001779
    14. the participant has a life expectancy of ≥ 3 months
    Description

    Life Expectancy

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0023671
    15. the participant is able to provide informed written consent and is amenable to compliance with protocol schedules and testing
    Description

    Informed Consent | Protocol Compliance

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0021430
    UMLS CUI [2]
    C0525058
    Exclusion Criteria
    Description

    Exclusion Criteria

    Alias
    UMLS CUI
    C0680251
    1. the participant has a concurrent active malignancy, other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. a participant with previous history of malignancy is eligible provided that she has been disease-free for > 3 years
    Description

    Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma Noninvasive Treated | Exception Carcinoma in Situ Treated

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0006826
    UMLS CUI [2,1]
    C1705847
    UMLS CUI [2,2]
    C0699893
    UMLS CUI [2,3]
    C1522326
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0007097
    UMLS CUI [3,3]
    C2986496
    UMLS CUI [3,4]
    C1522326
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0007099
    UMLS CUI [4,3]
    C1522326
    2. the participant has received a noncytotoxic regimen (usually called targeted therapy such as bevacizumab) for recurrent or persistent disease. (participants may have received a noncytotoxic regimen as primary treatment.)
    Description

    Non-Cytotoxic Drug Therapy Recurrent disease | Targeted Therapy Recurrent disease | Non-Cytotoxic Drug Therapy Persistent Disease | Targeted Therapy Persistent Disease | bevacizumab

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3898131
    UMLS CUI [1,2]
    C0277556
    UMLS CUI [2,1]
    C2985566
    UMLS CUI [2,2]
    C0277556
    UMLS CUI [3,1]
    C3898131
    UMLS CUI [3,2]
    C2983415
    UMLS CUI [4,1]
    C2985566
    UMLS CUI [4,2]
    C2983415
    UMLS CUI [5]
    C0796392
    3. the participant has received radiotherapy for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of study medication
    Description

    Therapeutic radiology procedure Ovarian Carcinoma | Therapeutic radiology procedure Fallopian Tube Carcinoma | Therapeutic radiology procedure Primary peritoneal carcinoma

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0029925
    UMLS CUI [2,1]
    C1522449
    UMLS CUI [2,2]
    C0238122
    UMLS CUI [3,1]
    C1522449
    UMLS CUI [3,2]
    C1514428
    4. the participant has received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last 3 years. [prior radiation for localized cancer (for example, of the breast, head and neck, or skin) is permitted, provided that it was completed > 3 years prior to the first dose of study medication, and the participant remains free of recurrent or metastatic disease.]
    Description

    Therapeutic radiology procedure Portion Abdominal Cavity | Radiotherapy to pelvis | Exception Therapeutic procedure Ovarian Carcinoma | Exception Therapeutic procedure Fallopian Tube Carcinoma | Exception Therapeutic procedure Primary peritoneal carcinoma | Prior radiation therapy Localized Carcinoma allowed

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1522449
    UMLS CUI [1,2]
    C0449719
    UMLS CUI [1,3]
    C0230168
    UMLS CUI [2]
    C1536155
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0087111
    UMLS CUI [3,3]
    C0029925
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0087111
    UMLS CUI [4,3]
    C0238122
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0087111
    UMLS CUI [5,3]
    C1514428
    UMLS CUI [6,1]
    C0279134
    UMLS CUI [6,2]
    C1334407
    UMLS CUI [6,3]
    C0683607
    5. the participant has received prior chemotherapy for any abdominal or pelvic tumor, other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer < 3 years prior to the first dose of study medication. prior adjuvant chemotherapy for localized breast cancer is permitted, provided that it was completed >3 years prior to the first dose of study medication, and that the participant remains free of recurrent or metastatic disease
    Description

    Prior Chemotherapy Abdominal Neoplasms | Prior Chemotherapy Pelvic Neoplasms | Exception Therapeutic procedure Ovarian Carcinoma | Exception Therapeutic procedure Fallopian Tube Carcinoma | Exception Therapeutic procedure Primary peritoneal carcinoma | Prior adjuvant chemotherapy Breast Carcinoma Localized allowed

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1514457
    UMLS CUI [1,2]
    C0000735
    UMLS CUI [2,1]
    C1514457
    UMLS CUI [2,2]
    C0030793
    UMLS CUI [3,1]
    C1705847
    UMLS CUI [3,2]
    C0087111
    UMLS CUI [3,3]
    C0029925
    UMLS CUI [4,1]
    C1705847
    UMLS CUI [4,2]
    C0087111
    UMLS CUI [4,3]
    C0238122
    UMLS CUI [5,1]
    C1705847
    UMLS CUI [5,2]
    C0087111
    UMLS CUI [5,3]
    C1514428
    UMLS CUI [6,1]
    C0281265
    UMLS CUI [6,2]
    C0678222
    UMLS CUI [6,3]
    C0392752
    UMLS CUI [6,4]
    C0683607
    6. the participant has undergone major abdominal surgery within 4 weeks (28 days) prior to first dose of study medication
    Description

    Operation on abdominal region Major

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0198482
    UMLS CUI [1,2]
    C0205164
    7. the participant has a suspected impending bowel obstruction, based on clinical or radiographic criteria
    Description

    Intestinal Obstruction Impending Suspected

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0021843
    UMLS CUI [1,2]
    C0332190
    UMLS CUI [1,3]
    C0750491
    8. the participant has received any hormonal therapy directed at the malignant tumor discontinued therapy within 1 week (7 days) prior to first dose of study medication
    Description

    Hormone Therapy Malignant Neoplasm Discontinued

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0279025
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [1,3]
    C1444662
    9. the participant has received any other prior therapy directed at the malignant tumor, including immunologic agents, within 3 weeks (21 days) prior to first dose of study medication
    Description

    Prior Therapy Malignant Neoplasms | IMMUNOLOGICAL AGENTS

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C1514463
    UMLS CUI [1,2]
    C0006826
    UMLS CUI [2]
    C1579312
    10. the participant has received previous treatment with ramucirumab
    Description

    ramucirumab

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2742502
    11. the participant has participated in clinical trials of experimental agents within 4 weeks (28 days) prior to first dose of study medication
    Description

    Study Subject Participation Status | Investigational New Drugs

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C2348568
    UMLS CUI [2]
    C0013230
    12. the participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
    Description

    Bleeding uncontrolled Hereditary | Bleeding uncontrolled Acquired | Thrombosis

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C3842135
    UMLS CUI [1,2]
    C0439660
    UMLS CUI [2,1]
    C3842135
    UMLS CUI [2,2]
    C0439661
    UMLS CUI [3]
    C0040053
    13. the participant has an ongoing or active infection requiring systemic antibiotics, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, myocardial infarction < 6 months, grade ≥ 2 peripheral vascular disease, poorly controlled hypertension despite standard medical management poorly controlled thrombotic or hemorrhagic disorder, psychiatric illness or social situations that would limit compliance with study requirements, or any other serious uncontrolled medical disorders in the opinion of the investigator
    Description

    Communicable Disease Requirement Antibiotics for systemic use | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Symptomatic | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction | Peripheral Vascular Disease Grade | Poor hypertension control | Thrombosis Poorly controlled | Hemorrhagic Disorder Poorly controlled | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance | Disease Serious Uncontrolled

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0009450
    UMLS CUI [1,2]
    C1514873
    UMLS CUI [1,3]
    C3540704
    UMLS CUI [2]
    C0742758
    UMLS CUI [3]
    C0002965
    UMLS CUI [4,1]
    C0003811
    UMLS CUI [4,2]
    C0231220
    UMLS CUI [5,1]
    C0003811
    UMLS CUI [5,2]
    C3853134
    UMLS CUI [6]
    C0027051
    UMLS CUI [7,1]
    C0085096
    UMLS CUI [7,2]
    C0441800
    UMLS CUI [8]
    C0421190
    UMLS CUI [9,1]
    C0040053
    UMLS CUI [9,2]
    C3853134
    UMLS CUI [10,1]
    C0019087
    UMLS CUI [10,2]
    C3853134
    UMLS CUI [11,1]
    C0004936
    UMLS CUI [11,2]
    C0439801
    UMLS CUI [11,3]
    C0525058
    UMLS CUI [12,1]
    C0748872
    UMLS CUI [12,2]
    C0439801
    UMLS CUI [12,3]
    C0525058
    UMLS CUI [13,1]
    C0012634
    UMLS CUI [13,2]
    C0205404
    UMLS CUI [13,3]
    C0205318
    14. the participant has any history of brain metastases or leptomeningeal disease. screening for central nervous system (cns) involvement for testing asymptomatic participants is not required
    Description

    Metastatic malignant neoplasm to brain | Disease Leptomeningeal

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0220650
    UMLS CUI [2,1]
    C0012634
    UMLS CUI [2,2]
    C0521401
    15. the participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
    Description

    HIV Infection | Illness Relationship Acquired Immunodeficiency Syndrome

    Type de données

    boolean

    Alias
    UMLS CUI [1]
    C0019693
    UMLS CUI [2,1]
    C0221423
    UMLS CUI [2,2]
    C0439849
    UMLS CUI [2,3]
    C0001175
    16. the participant is pregnant [confirmed by serum beta human chorionic gonadotropin (β-hcg) test] or lactating
    Description

    Pregnancy Serum Beta-HCG Test | Breast Feeding

    Type de données

    boolean

    Alias
    UMLS CUI [1,1]
    C0032961
    UMLS CUI [1,2]
    C1255526
    UMLS CUI [2]
    C0006147
    Retour au début de la page

    Similar models

    Eligibility Ovarian Cancer NCT00721162

    1 Formulaires
    Name
    Type
    Description | Question | Decode (Coded Value)
    Type de données
    Alias
    Item Group
    C1512693 (UMLS CUI)
    Criteria Fulfill
    Item
    each participant must meet the following criteria to be enrolled in this study:
    boolean
    C0243161 (UMLS CUI [1,1])
    C1550543 (UMLS CUI [1,2])
    Epithelial ovarian cancer Recurrent | Epithelial ovarian cancer Persistent | Recurrent Fallopian Tube Carcinoma | Fallopian Tube Carcinoma Persistent | Recurrent Primary Peritoneal Carcinoma | Primary peritoneal carcinoma Persistent | Primary tumor Documented Histologic
    Item
    1. the participant has recurrent or persistent epithelial ovarian, fallopian tube, or primary peritoneal carcinoma. histologic documentation of the original primary tumor is required via a pathology report
    boolean
    C0677886 (UMLS CUI [1,1])
    C2945760 (UMLS CUI [1,2])
    C0677886 (UMLS CUI [2,1])
    C0205322 (UMLS CUI [2,2])
    C3897738 (UMLS CUI [3])
    C0238122 (UMLS CUI [4,1])
    C0205322 (UMLS CUI [4,2])
    C3897731 (UMLS CUI [5])
    C1514428 (UMLS CUI [6,1])
    C0205322 (UMLS CUI [6,2])
    C0677930 (UMLS CUI [7,1])
    C1301725 (UMLS CUI [7,2])
    C0205462 (UMLS CUI [7,3])
    Measurable lesion Linear Quantity | Target Lesion Identification Measurement conventional | Target Lesion Identification Spiral CT | Target Lesion Identification MRI
    Item
    2. the participant has at least one unidimensional-measurable target lesion [≥ 2 centimeter (cm) with conventional techniques, or ≥ 1 cm by spiral computed tomography (ct) or magnetic resonance imaging (mri)], as defined by response evaluation criteria in solid tumors (recist). tumors within a previously irradiated field will be designated as "nontarget" lesions unless progression is documented or a biopsy is obtained to confirm persistence at least 90 days following completion of radiation therapy
    boolean
    C1513041 (UMLS CUI [1,1])
    C0205132 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C2986546 (UMLS CUI [2,1])
    C0242485 (UMLS CUI [2,2])
    C0439858 (UMLS CUI [2,3])
    C2986546 (UMLS CUI [3,1])
    C0860888 (UMLS CUI [3,2])
    C2986546 (UMLS CUI [4,1])
    C0024485 (UMLS CUI [4,2])
    Effects of Therapeutic procedure Patient recovered CTCAE Grades | Operative Surgical Procedures Ovarian Carcinoma | Therapeutic radiology procedure Ovarian Carcinoma | Chemotherapy Ovarian Carcinoma | Hormone Therapy Ovarian Carcinoma | Targeted Therapy Ovarian Carcinoma | Exception Alopecia | Exception Peripheral Neuropathy CTCAE Grades | Prior Therapy Malignant Neoplasms To be stopped | Hormone Therapy To be stopped | Hormone replacement therapy Continuous allowed
    Item
    3. the participant has recovered to grade ≤ 1 by the national cancer institute common terminology criteria for adverse events, version 3.0 (nci-ctcae v3.0) from the effects of recent surgery, radiotherapy, chemotherapy, hormonal therapy, or other targeted therapies for ovarian cancer, with the exception of alopecia or peripheral neuropathy (which must have resolved to grade ≤ 2). any other prior therapy directed at the malignant tumor must be discontinued at least three weeks prior to the first dose of study medication, or hormonal therapy discontinued at least one week prior to the first dose of study medication. continuation of hormone replacement therapy is permitted
    boolean
    C1704420 (UMLS CUI [1,1])
    C0087111 (UMLS CUI [1,2])
    C1115804 (UMLS CUI [1,3])
    C1516728 (UMLS CUI [1,4])
    C0543467 (UMLS CUI [2,1])
    C0029925 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [3,1])
    C0029925 (UMLS CUI [3,2])
    C0392920 (UMLS CUI [4,1])
    C0029925 (UMLS CUI [4,2])
    C0279025 (UMLS CUI [5,1])
    C0029925 (UMLS CUI [5,2])
    C2985566 (UMLS CUI [6,1])
    C0029925 (UMLS CUI [6,2])
    C1705847 (UMLS CUI [7,1])
    C0002170 (UMLS CUI [7,2])
    C1705847 (UMLS CUI [8,1])
    C0031117 (UMLS CUI [8,2])
    C1516728 (UMLS CUI [8,3])
    C1514463 (UMLS CUI [9,1])
    C0006826 (UMLS CUI [9,2])
    C1272691 (UMLS CUI [9,3])
    C0279025 (UMLS CUI [10,1])
    C1272691 (UMLS CUI [10,2])
    C0282402 (UMLS CUI [11,1])
    C0549178 (UMLS CUI [11,2])
    C0683607 (UMLS CUI [11,3])
    Chemotherapy Regimen Platinum-Based Quantity | Primary disorder Management | Interval Free of Platinum | Disease Progression | Persistent Disease
    Item
    4. the participant has completed at least one platinum-based chemotherapeutic regimen for management of primary disease, and must have at least one of the following: a platinum-free interval of < 12 months after the final dose of primary platinum-based therapy, progression during platinum-based therapy, or persistent disease after platinum-based therapy
    boolean
    C0392920 (UMLS CUI [1,1])
    C1514162 (UMLS CUI [1,2])
    C1265611 (UMLS CUI [1,3])
    C0277554 (UMLS CUI [2,1])
    C0376636 (UMLS CUI [2,2])
    C1272706 (UMLS CUI [3,1])
    C0332296 (UMLS CUI [3,2])
    C0032207 (UMLS CUI [3,3])
    C0242656 (UMLS CUI [4])
    C2983415 (UMLS CUI [5])
    ECOG performance status
    Item
    5. the participant has an eastern cooperative oncology group performance status (ecog ps) of 0-1 at study entry
    boolean
    C1520224 (UMLS CUI [1])
    Hematologic function | Absolute neutrophil count
    Item
    6. the participant has adequate hematological functions [absolute neutrophil count (anc)
    boolean
    C0221130 (UMLS CUI [1])
    C0948762 (UMLS CUI [2])
    Hemoglobin measurement
    Item
    ≥ 1200 cells/microliter (ul), hemoglobin ≥ 9 grams/deciliter (g/dl), and platelets ≥
    boolean
    C0518015 (UMLS CUI [1])
    Platelet Count measurement
    Item
    100,000 cells/ul]
    boolean
    C0032181 (UMLS CUI [1])
    Liver function | Serum total bilirubin measurement | Aspartate aminotransferase measurement | Alanine aminotransferase measurement | Transaminases increased Due to Secondary malignant neoplasm of liver
    Item
    7. the participant has adequate hepatic function [bilirubin ≤ 1.5 times the upper limit of normal (uln); aspartate transaminase (ast) and/or alanine transaminase (alt) ≤ 3.0 times uln, or ≤ 5.0 times uln if the transaminase elevation is due to liver metastases]
    boolean
    C0232741 (UMLS CUI [1])
    C1278039 (UMLS CUI [2])
    C0201899 (UMLS CUI [3])
    C0201836 (UMLS CUI [4])
    C0438717 (UMLS CUI [5,1])
    C0678226 (UMLS CUI [5,2])
    C0494165 (UMLS CUI [5,3])
    Renal function | Creatinine measurement, serum | Creatinine clearance measurement | Estimation of creatinine clearance by Cockcroft-Gault formula
    Item
    8. the participant has adequate renal function [serum creatinine ≤ 1.5 x uln or creatinine clearance (measured or calculated) ≥ 60 milliliters/minute (ml/min)]
    boolean
    C0232804 (UMLS CUI [1])
    C0201976 (UMLS CUI [2])
    C0373595 (UMLS CUI [3])
    C2711451 (UMLS CUI [4])
    Proteinuria Dipstick test | Proteinuria Urinalysis | 24 hour urine sample
    Item
    9. the participant's urinary protein is ≤ 1+ on dipstick or routine urinalysis (ua). if urine dipstick or routine analysis indicated ≥ 2+ proteinuria, then a 24-hour urine must be collected and must demonstrate < 1000 milligrams (mg) of protein in 24 hours to allow participation in the study
    boolean
    C0033687 (UMLS CUI [1,1])
    C0430370 (UMLS CUI [1,2])
    C0033687 (UMLS CUI [2,1])
    C0042014 (UMLS CUI [2,2])
    C0456209 (UMLS CUI [3])
    Coagulation function analysis | International Normalized Ratio | Partial Thromboplastin Time measurement | Anticoagulation Therapy Absent | Anticoagulation Therapy Dose Full | Oral anticoagulants Dose Stable | Low-Molecular-Weight Heparin Dose Stable | Warfarin | INR Therapeutic | Hemorrhage Absent | Medical condition High risk of bleeding | Neoplasm Involving Blood Vessel Major | Varices
    Item
    10. the participant has adequate coagulation function, as defined by international normalized ratio (inr) ≤ 1.5 and a partial thromboplastin time (ptt) ≤ 1.5 x uln if not receiving anticoagulation therapy. participants on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin, and if on warfarin must have therapeutic inr and have no active bleeding (defined as within 14 days of first dose of study medication) or pathological condition that carries a high risk of bleeding (example, tumor involving major vessels or known varices)
    boolean
    C3516400 (UMLS CUI [1])
    C0525032 (UMLS CUI [2])
    C0030605 (UMLS CUI [3])
    C0003281 (UMLS CUI [4,1])
    C0332197 (UMLS CUI [4,2])
    C0003281 (UMLS CUI [5,1])
    C0178602 (UMLS CUI [5,2])
    C0443225 (UMLS CUI [5,3])
    C0354604 (UMLS CUI [6,1])
    C0178602 (UMLS CUI [6,2])
    C0205360 (UMLS CUI [6,3])
    C0019139 (UMLS CUI [7,1])
    C0178602 (UMLS CUI [7,2])
    C0205360 (UMLS CUI [7,3])
    C0043031 (UMLS CUI [8])
    C0525032 (UMLS CUI [9,1])
    C0302350 (UMLS CUI [9,2])
    C0019080 (UMLS CUI [10,1])
    C0332197 (UMLS CUI [10,2])
    C3843040 (UMLS CUI [11,1])
    C4039184 (UMLS CUI [11,2])
    C0027651 (UMLS CUI [12,1])
    C1314939 (UMLS CUI [12,2])
    C0005847 (UMLS CUI [12,3])
    C0205164 (UMLS CUI [12,4])
    C0042345 (UMLS CUI [13])
    Anthracyclines | Left ventricular ejection fraction Normal Echocardiography pre treatment | Left ventricular ejection fraction Normal MUGA scan pre treatment
    Item
    11. for participants who have received anthracycline therapy, the left ventricular ejection fraction (lvef) must be within normal institutional range by a pretreatment echocardiogram or multigated acquisition (muga) scan
    boolean
    C0282564 (UMLS CUI [1])
    C0428772 (UMLS CUI [2,1])
    C0205307 (UMLS CUI [2,2])
    C0013516 (UMLS CUI [2,3])
    C2709094 (UMLS CUI [2,4])
    C0428772 (UMLS CUI [3,1])
    C0205307 (UMLS CUI [3,2])
    C0521317 (UMLS CUI [3,3])
    C2709094 (UMLS CUI [3,4])
    Sexually active Postmenopausal state | Sexually active Female Sterilization | Sexually active Contraceptive methods
    Item
    12. if sexually active, the participant is post-menopausal, surgically sterile, or using effective contraception in the opinion of the investigator
    boolean
    C0241028 (UMLS CUI [1,1])
    C0232970 (UMLS CUI [1,2])
    C0241028 (UMLS CUI [2,1])
    C0015787 (UMLS CUI [2,2])
    C0241028 (UMLS CUI [3,1])
    C0700589 (UMLS CUI [3,2])
    Age
    Item
    13. the participant is ≥ 18 years of age
    boolean
    C0001779 (UMLS CUI [1])
    Life Expectancy
    Item
    14. the participant has a life expectancy of ≥ 3 months
    boolean
    C0023671 (UMLS CUI [1])
    Informed Consent | Protocol Compliance
    Item
    15. the participant is able to provide informed written consent and is amenable to compliance with protocol schedules and testing
    boolean
    C0021430 (UMLS CUI [1])
    C0525058 (UMLS CUI [2])
    Item Group
    C0680251 (UMLS CUI)
    Malignant Neoplasms | Exception Skin carcinoma Treated | Exception Carcinoma Noninvasive Treated | Exception Carcinoma in Situ Treated
    Item
    1. the participant has a concurrent active malignancy, other than adequately treated nonmelanomatous skin cancer or other noninvasive carcinoma or in situ neoplasm. a participant with previous history of malignancy is eligible provided that she has been disease-free for > 3 years
    boolean
    C0006826 (UMLS CUI [1])
    C1705847 (UMLS CUI [2,1])
    C0699893 (UMLS CUI [2,2])
    C1522326 (UMLS CUI [2,3])
    C1705847 (UMLS CUI [3,1])
    C0007097 (UMLS CUI [3,2])
    C2986496 (UMLS CUI [3,3])
    C1522326 (UMLS CUI [3,4])
    C1705847 (UMLS CUI [4,1])
    C0007099 (UMLS CUI [4,2])
    C1522326 (UMLS CUI [4,3])
    Non-Cytotoxic Drug Therapy Recurrent disease | Targeted Therapy Recurrent disease | Non-Cytotoxic Drug Therapy Persistent Disease | Targeted Therapy Persistent Disease | bevacizumab
    Item
    2. the participant has received a noncytotoxic regimen (usually called targeted therapy such as bevacizumab) for recurrent or persistent disease. (participants may have received a noncytotoxic regimen as primary treatment.)
    boolean
    C3898131 (UMLS CUI [1,1])
    C0277556 (UMLS CUI [1,2])
    C2985566 (UMLS CUI [2,1])
    C0277556 (UMLS CUI [2,2])
    C3898131 (UMLS CUI [3,1])
    C2983415 (UMLS CUI [3,2])
    C2985566 (UMLS CUI [4,1])
    C2983415 (UMLS CUI [4,2])
    C0796392 (UMLS CUI [5])
    Therapeutic radiology procedure Ovarian Carcinoma | Therapeutic radiology procedure Fallopian Tube Carcinoma | Therapeutic radiology procedure Primary peritoneal carcinoma
    Item
    3. the participant has received radiotherapy for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within 3 weeks (21 days) prior to the first dose of study medication
    boolean
    C1522449 (UMLS CUI [1,1])
    C0029925 (UMLS CUI [1,2])
    C1522449 (UMLS CUI [2,1])
    C0238122 (UMLS CUI [2,2])
    C1522449 (UMLS CUI [3,1])
    C1514428 (UMLS CUI [3,2])
    Therapeutic radiology procedure Portion Abdominal Cavity | Radiotherapy to pelvis | Exception Therapeutic procedure Ovarian Carcinoma | Exception Therapeutic procedure Fallopian Tube Carcinoma | Exception Therapeutic procedure Primary peritoneal carcinoma | Prior radiation therapy Localized Carcinoma allowed
    Item
    4. the participant has received prior radiotherapy to any portion of the abdominal cavity or pelvis other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer within the last 3 years. [prior radiation for localized cancer (for example, of the breast, head and neck, or skin) is permitted, provided that it was completed > 3 years prior to the first dose of study medication, and the participant remains free of recurrent or metastatic disease.]
    boolean
    C1522449 (UMLS CUI [1,1])
    C0449719 (UMLS CUI [1,2])
    C0230168 (UMLS CUI [1,3])
    C1536155 (UMLS CUI [2])
    C1705847 (UMLS CUI [3,1])
    C0087111 (UMLS CUI [3,2])
    C0029925 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0087111 (UMLS CUI [4,2])
    C0238122 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0087111 (UMLS CUI [5,2])
    C1514428 (UMLS CUI [5,3])
    C0279134 (UMLS CUI [6,1])
    C1334407 (UMLS CUI [6,2])
    C0683607 (UMLS CUI [6,3])
    Prior Chemotherapy Abdominal Neoplasms | Prior Chemotherapy Pelvic Neoplasms | Exception Therapeutic procedure Ovarian Carcinoma | Exception Therapeutic procedure Fallopian Tube Carcinoma | Exception Therapeutic procedure Primary peritoneal carcinoma | Prior adjuvant chemotherapy Breast Carcinoma Localized allowed
    Item
    5. the participant has received prior chemotherapy for any abdominal or pelvic tumor, other than for the treatment of ovarian, fallopian tube, or primary peritoneal cancer < 3 years prior to the first dose of study medication. prior adjuvant chemotherapy for localized breast cancer is permitted, provided that it was completed >3 years prior to the first dose of study medication, and that the participant remains free of recurrent or metastatic disease
    boolean
    C1514457 (UMLS CUI [1,1])
    C0000735 (UMLS CUI [1,2])
    C1514457 (UMLS CUI [2,1])
    C0030793 (UMLS CUI [2,2])
    C1705847 (UMLS CUI [3,1])
    C0087111 (UMLS CUI [3,2])
    C0029925 (UMLS CUI [3,3])
    C1705847 (UMLS CUI [4,1])
    C0087111 (UMLS CUI [4,2])
    C0238122 (UMLS CUI [4,3])
    C1705847 (UMLS CUI [5,1])
    C0087111 (UMLS CUI [5,2])
    C1514428 (UMLS CUI [5,3])
    C0281265 (UMLS CUI [6,1])
    C0678222 (UMLS CUI [6,2])
    C0392752 (UMLS CUI [6,3])
    C0683607 (UMLS CUI [6,4])
    Operation on abdominal region Major
    Item
    6. the participant has undergone major abdominal surgery within 4 weeks (28 days) prior to first dose of study medication
    boolean
    C0198482 (UMLS CUI [1,1])
    C0205164 (UMLS CUI [1,2])
    Intestinal Obstruction Impending Suspected
    Item
    7. the participant has a suspected impending bowel obstruction, based on clinical or radiographic criteria
    boolean
    C0021843 (UMLS CUI [1,1])
    C0332190 (UMLS CUI [1,2])
    C0750491 (UMLS CUI [1,3])
    Hormone Therapy Malignant Neoplasm Discontinued
    Item
    8. the participant has received any hormonal therapy directed at the malignant tumor discontinued therapy within 1 week (7 days) prior to first dose of study medication
    boolean
    C0279025 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C1444662 (UMLS CUI [1,3])
    Prior Therapy Malignant Neoplasms | IMMUNOLOGICAL AGENTS
    Item
    9. the participant has received any other prior therapy directed at the malignant tumor, including immunologic agents, within 3 weeks (21 days) prior to first dose of study medication
    boolean
    C1514463 (UMLS CUI [1,1])
    C0006826 (UMLS CUI [1,2])
    C1579312 (UMLS CUI [2])
    ramucirumab
    Item
    10. the participant has received previous treatment with ramucirumab
    boolean
    C2742502 (UMLS CUI [1])
    Study Subject Participation Status | Investigational New Drugs
    Item
    11. the participant has participated in clinical trials of experimental agents within 4 weeks (28 days) prior to first dose of study medication
    boolean
    C2348568 (UMLS CUI [1])
    C0013230 (UMLS CUI [2])
    Bleeding uncontrolled Hereditary | Bleeding uncontrolled Acquired | Thrombosis
    Item
    12. the participant has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders
    boolean
    C3842135 (UMLS CUI [1,1])
    C0439660 (UMLS CUI [1,2])
    C3842135 (UMLS CUI [2,1])
    C0439661 (UMLS CUI [2,2])
    C0040053 (UMLS CUI [3])
    Communicable Disease Requirement Antibiotics for systemic use | Symptomatic congestive heart failure | Angina, Unstable | Cardiac Arrhythmia Symptomatic | Cardiac Arrhythmia Poorly controlled | Myocardial Infarction | Peripheral Vascular Disease Grade | Poor hypertension control | Thrombosis Poorly controlled | Hemorrhagic Disorder Poorly controlled | Mental disorder Limiting Protocol Compliance | Social situation Limiting Protocol Compliance | Disease Serious Uncontrolled
    Item
    13. the participant has an ongoing or active infection requiring systemic antibiotics, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, myocardial infarction < 6 months, grade ≥ 2 peripheral vascular disease, poorly controlled hypertension despite standard medical management poorly controlled thrombotic or hemorrhagic disorder, psychiatric illness or social situations that would limit compliance with study requirements, or any other serious uncontrolled medical disorders in the opinion of the investigator
    boolean
    C0009450 (UMLS CUI [1,1])
    C1514873 (UMLS CUI [1,2])
    C3540704 (UMLS CUI [1,3])
    C0742758 (UMLS CUI [2])
    C0002965 (UMLS CUI [3])
    C0003811 (UMLS CUI [4,1])
    C0231220 (UMLS CUI [4,2])
    C0003811 (UMLS CUI [5,1])
    C3853134 (UMLS CUI [5,2])
    C0027051 (UMLS CUI [6])
    C0085096 (UMLS CUI [7,1])
    C0441800 (UMLS CUI [7,2])
    C0421190 (UMLS CUI [8])
    C0040053 (UMLS CUI [9,1])
    C3853134 (UMLS CUI [9,2])
    C0019087 (UMLS CUI [10,1])
    C3853134 (UMLS CUI [10,2])
    C0004936 (UMLS CUI [11,1])
    C0439801 (UMLS CUI [11,2])
    C0525058 (UMLS CUI [11,3])
    C0748872 (UMLS CUI [12,1])
    C0439801 (UMLS CUI [12,2])
    C0525058 (UMLS CUI [12,3])
    C0012634 (UMLS CUI [13,1])
    C0205404 (UMLS CUI [13,2])
    C0205318 (UMLS CUI [13,3])
    Metastatic malignant neoplasm to brain | Disease Leptomeningeal
    Item
    14. the participant has any history of brain metastases or leptomeningeal disease. screening for central nervous system (cns) involvement for testing asymptomatic participants is not required
    boolean
    C0220650 (UMLS CUI [1])
    C0012634 (UMLS CUI [2,1])
    C0521401 (UMLS CUI [2,2])
    HIV Infection | Illness Relationship Acquired Immunodeficiency Syndrome
    Item
    15. the participant has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness
    boolean
    C0019693 (UMLS CUI [1])
    C0221423 (UMLS CUI [2,1])
    C0439849 (UMLS CUI [2,2])
    C0001175 (UMLS CUI [2,3])
    Pregnancy Serum Beta-HCG Test | Breast Feeding
    Item
    16. the participant is pregnant [confirmed by serum beta human chorionic gonadotropin (β-hcg) test] or lactating
    boolean
    C0032961 (UMLS CUI [1,1])
    C1255526 (UMLS CUI [1,2])
    C0006147 (UMLS CUI [2])
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