Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites

The study included:

• A Thirty (30)-day screening phase
• The double blind treatment period for a minimum of 60 days. Day 1 of the double-blind treatment period was defined as the date of the qualifying paracentesis (ie, withdrawal of >= 1 Liter of ascitic fluid). Participants were randomized after adequate recovery from the qualifying paracentesis (The first dose was administered on Day 1 or Day 2).
• The optional open-label extension (until treatment discontinuation criteria were met)
• A posttreatment follow-up phase lasting 60 days.

Criteria for discontinuation included:

• Participant or his legally authorized representative request discontinuation
• In the Investigator's opinion, continuation of treatment would be detrimental to the participant's well being, such as disease progression, unacceptable toxicity, noncompliance, or logistical considerations
• Sponsor request
• Intercurrent illness that prevented further administration of investigational product(IP)
• More than 2 IP dose reductions
• Unacceptable adverse events (AE) not manageable by symptomatic therapy, dose delay, or dose modification
• Arterial thromboembolic events, including cerebrovascular accidents, myocardial infarctions, transient ischemic attacks, new onset or worsening of preexisting angina
• Radiographic evidence of intestinal obstruction (for example, dilated loops of bowel accompanied by air-fluid levels) or gastrointestinal perforation (for example, presence of extraluminal gas) requiring surgical intervention

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.