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])
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])