ID

31333

Beschreibung

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

Link

https://clinicaltrials.gov/show/NCT00721162

Stichworte

Versionen (1)
  1. 14.08.18 14.08.18 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

14. August 2018

DOI

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Lizenz

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Eligibility Ovarian Cancer NCT00721162

Englisch

Eligibility Ovarian Cancer NCT00721162

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

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

Criteria Fulfill

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

ECOG performance status

Datentyp

boolean

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

Hematologic function | Absolute neutrophil count

Datentyp

boolean

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

Hemoglobin measurement

Datentyp

boolean

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

Platelet Count measurement

Datentyp

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]
Beschreibung

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

Datentyp

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)]
Beschreibung

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

Datentyp

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
Beschreibung

Proteinuria Dipstick test | Proteinuria Urinalysis | 24 hour urine sample

Datentyp

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)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Age

Datentyp

boolean

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

Life Expectancy

Datentyp

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
Beschreibung

Informed Consent | Protocol Compliance

Datentyp

boolean

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

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
Beschreibung

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

Datentyp

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.)
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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.]
Beschreibung

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

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Operation on abdominal region Major

Datentyp

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
Beschreibung

Intestinal Obstruction Impending Suspected

Datentyp

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
Beschreibung

Hormone Therapy Malignant Neoplasm Discontinued

Datentyp

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
Beschreibung

Prior Therapy Malignant Neoplasms | IMMUNOLOGICAL AGENTS

Datentyp

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
Beschreibung

ramucirumab

Datentyp

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
Beschreibung

Study Subject Participation Status | Investigational New Drugs

Datentyp

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
Beschreibung

Bleeding uncontrolled Hereditary | Bleeding uncontrolled Acquired | Thrombosis

Datentyp

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
Beschreibung

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

Datentyp

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
Beschreibung

Metastatic malignant neoplasm to brain | Disease Leptomeningeal

Datentyp

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
Beschreibung

HIV Infection | Illness Relationship Acquired Immunodeficiency Syndrome

Datentyp

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
Beschreibung

Pregnancy Serum Beta-HCG Test | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0032961
UMLS CUI [1,2]
C1255526
UMLS CUI [2]
C0006147
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Ähnliche Modelle

Eligibility Ovarian Cancer NCT00721162

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
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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