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

• Status: Completed
• Trial end date: 2009-10-01
• Target enrollment: 0
• Participant gender: Female

Summary

This study was designed to characterize the effect of aflibercept in participants with advanced chemoresistant ovarian cancer.

Primary objective: Compare the effect of aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) to placebo treatment on repeat paracentesis in symptomatic malignant ascites in participants with advanced ovarian cancer

Secondary objectives: Safety, tolerability, paracentesis-related parameters, participant-reported outcome.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Collaborator: Regeneron Pharmaceuticals
• Treatments: Aflibercept

Criteria

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.