Status:
COMPLETED
Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Lead Sponsor:
Sanofi
Collaborating Sponsors:
Regeneron Pharmaceuticals
Conditions:
Ovarian Neoplasms
Ascites
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
PHASE3
Brief 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, A...
Detailed Description
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 qualify...
Eligibility Criteria
Inclusion
- Participants who met the following criteria were eligible to participate in this study.
- 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
- 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.
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2009
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT00327444
Start Date
July 1 2006
End Date
October 1 2009
Last Update
January 1 2013
Active Locations (9)
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1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Vienna, Austria
3
Sanofi-Aventis Administrative Office
Diegem, Belgium
4
Sanofi-Aventis Administrative Office
Laval, Canada