Please select the eligibility criteria that correspond to the clinical trial below.
Title: A Multicenter, Randomized, Double-blind, Parallel-arm, Two-stage Study of the Efficacy and Safety of AVE0005 (VEGF Trap) Administered Intravenously Every 2 Weeks in Patients With Platinum-resistant and topotecan-and/or Liposomal Doxorubicin-resistant Advanced Ovarian Cancer
Brief Summary: This study evaluated outcomes in participants with advanced ovarian epithelial adenocarcinoma receiving aflibercept.

The primary objective was to compare the objective response rate of Aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) 4.0 mg/kg and 2.0 mg/kg, administered intravenously (IV) every 2 weeks with historical control in participants with advanced ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma resistant to platinum and topotecan and/or liposomal doxorubicin.

The secondary objectives was to further assess efficacy, safety, pharmacokinetics, potential biological and pharmacogenomic markers of study drug activity, and health-related quality of life.

This study employed an Independent Review Committee (IRC) for radiological tumor assessments. For all tumor assessment-related efficacy variables, two analyses were performed: the primary analysis was based on Independent Review Committee (IRC) reviewed data and the secondary analysis was based on Investigator evaluation. If an endpoint was evaluated by the IRC, the IRC reviewed data is reported for this study.


Options:
A: Participants who met the following criteria were eligible to participate in this study.

Inclusion Criteria:

* Advanced ovarian epithelial cancer, treated with paracentesis
* Platinum-resistant, and topotecan-resistant and/or liposomal doxorubicin-resistant disease;
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2.

Exclusion Criteria:

* Pseudomyxoma peritonei or peritoneal mesothelioma;
* Transudative ascites;
* Peritoneovenous or other shunt placed for malignant ascites management;
* Recent (\<6 months) cardiovascular event (pulmonary embolus, myocardial infarction, stroke) or gastrointestinal disease (ulcer, hepatic cirrhosis);
* Known brain metastases;
* Uncontrolled hypertension;
* Recent treatment with chemotherapy, surgery or radiotherapy;
* Prior treatment with VEGF or VEGFR inhibitor.

The above information is not intended to contain all considerations relevant to participation in a clinical trial.
B: Inclusion Criteria:

* Are a woman 18 years of age or older
* Have histologically or cytologically confirmed epithelial cancer or primary peritoneal cancer
* Have platinum refractory or resistant cancer
* Measurable disease according to radiographic RECIST criteria progression

Exclusion Criteria:

* Had treatment with first-line chemotherapy other than a platinum-containing regimen
* Have clinically significant cardiac disease
* Have any sign of intestinal obstruction interfering with nutrition
* Are pregnant or lactating
* Had prior treatment with liposomal doxorubicin
* Had prior treatment with Telcyta
C: Participants who met the following criteria were eligible for the study.

Inclusion Criteria:

* Histologically-confirmed ovarian epithelial (including fallopian tube and primary peritoneal) adenocarcinoma.
* Prior treatment with at least 2 treatment regimens in the advanced disease treatment setting
* Platinum-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance
* Topotecan- and/or liposomal doxorubicin-resistant disease defined by relapse or progression of disease during or after treatment, or drug intolerance
* Evidence of at least one unidimensional measurable tumor lesion by computed tomography (CT) or magnetic resonance imaging (MRI) scan according to Response Evaluation Criteria in Solid Tumors (RECIST) that has not been treated with surgery or radiation therapy

Exclusion Criteria:

* Diagnosis of any second malignancy within the last 5 years, except for adequately treated basal cell or squamous cell skin cancer, or for in situ carcinoma of the cervix uteri
* Prior treatment with a vascular endothelial growth factor (VEGF) or VEGF receptor inhibitor
* More than 3 chemotherapy regimens in the advanced disease treatment setting
* Uncontrolled hypertension

The above information is not intended to contain all considerations relevant to potential participation in a clinical trial.
D: Inclusion Criteria:

1. Female subjects who are at least 18 years of age at the time of informed consent
2. CA125 less than or equal to 3 x upper limit of normal (ULN) \[105 units per millilitre (U/mL)\] confirmed within 2 weeks of randomization using a centralized laboratory assay
3. A histologically confirmed diagnosis of high-grade serous epithelial ovarian cancer including primary peritoneal and fallopian tube malignancies; all other histologies, including mixed histology, are excluded
4. Have been treated with debulking surgery and a first-line platinum-based chemotherapy regimen
5. Maintenance therapy during the first platinum-free interval is allowed; however, the last dose must have been at least 21 days prior to Randomization.
6. Must be in a first relapse and have evaluable disease by Computed Tomography (CT) or Magnetic Resonance Imaging (MRI) scan, according to RECIST 1.1 (subjects with measurable disease per RECIST 1.1 or radiographically visible and evaluable disease). Subjects with only ascites or pleural effusion are excluded.
7. Must have relapsed radiographically between 6 months and 36 months of completion of first-line platinum chemotherapy
8. Must be a candidate for treatment with either carboplatin plus paclitaxel or carboplatin plus PLD with no medical contraindications present as outlined in the product labels for the selected regimen to be used in this study
9. Have a life expectancy of at least 6 months, as estimated by the investigator
10. Other significant medical conditions must be well-controlled and stable in the opinion of the investigator for at least 30 days prior to Randomization
11. Have an Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2
12. Subjects being enrolled to receive paclitaxel plus carboplatin treatment must have neuropathic function (sensory and motor less than or equal to Grade 2 according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE) v4.03 (2010)
13. Laboratory results within the 2 weeks prior to Randomization must be as follows:

    * Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10\^9/L
    * Platelet count greater than or equal to 100 x 10\^9/L
    * Hemoglobin greater than or equal to 9 g/dL
    * Creatinine less than 1.5 x ULN (CTCAE Grade 1)
    * Bilirubin less than 1.5 x ULN (CTCAE Grade 1)
    * Aspartate Aminotransferase (AST) and Alanine Aminotransferase (ALT) less than 3 x ULN
    * Alkaline Phosphatase less than 2.5 x ULN (CTCAE Grade 1)
    * Baseline albumin greater than or equal to Lower Limit of Normal
14. Subjects of childbearing potential must be surgically sterile or consent to use a medically acceptable method of contraception throughout the study period. All females will be considered to be of childbearing potential unless they are postmenopausal (eg, amenorrheic for at least 12 consecutive months, in the appropriate age group, and without other known or suspected cause) or have been sterilized surgically (ie, bilateral tubal ligation, total hysterectomy, or bilateral oophorectomy, all with surgery at least 1 month before dosing). If a patient of childbearing potential is neither surgically sterile nor postmenopausal, a highly-effective contraceptive method (ie, a method that can achieve a failure rate of less than 1 percent (%) per year when used consistently and correctly) must start either before or at Screening and continue throughout the entire study period and for 6 months after the last dose of Test Article is administered. Pregnant and/or lactating females are excluded

Exclusion Criteria:

1. Known central nervous system (CNS) tumor involvement
2. Evidence of other active invasive malignancy requiring treatment other than surgery in the past 3 years
3. Clinically significant heart disease (eg, congestive heart failure of New York Heart Association Class 3 or 4 angina, not well controlled by medication, or myocardial infarction within 6 months)
4. Electrocardiogram (ECG) demonstrating clinically significant arrhythmias that are not adequately medically managed (Note: subjects with chronic atrial arrhythmia, ie, atrial fibrillation or paroxysmal supraventricular tachycardia \[SVT\], are eligible)
5. Active serious systemic disease, including active bacterial or fungal infection
6. Active viral hepatitis or active human immunodeficiency virus (HIV) infection. Asymptomatic positive serology is not exclusionary.
7. Other concurrent immunotherapy (eg, immunosuppressants or chronic use of systemic corticosteroids, with the exception that low-dose corticosteroids \[50 mg/day prednisone or equivalent corticosteroid\] are allowed; these should be discussed with the Medical Monitor)
8. Known allergic reaction to a prior monoclonal antibody therapy or have any documented Anti-Drug Antibody (ADA) response; additionally known allergic reaction to the concomitant chemotherapies selected by the investigator for planned treatment in this study unless desensitization is planned
9. Previous treatment with farletuzumab or other folate receptor targeting agents
10. Previous treatment with cancer vaccine therapy
11. For subjects being enrolled to receive PLD plus carboplatin, prior treatment with anthracyclines or anthracenodiones
12. Breast-feeding, pregnant, or likely to become pregnant during the study
13. Any medical or other condition that, in the opinion of the investigator, would preclude the subject's participation in a clinical study including medical contraindications as outlined in the product labels for the chemotherapies selected by the investigator for planned treatment in this study
14. Patients who have had secondary debulking surgery or any second line therapy
15. Currently enrolled in another clinical study or used any investigational drug or device within 30 days (or 5 x half-life for investigational drugs where the half-life is known) preceding informed consent

Answer: C