Phase 3
N=55
Study of the Effect of Intravenous AVE0005 (VEGF Trap) in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites
Ovarian Neoplasms · Ascites
Bottom Line
View on ClinicalTrials.gov: NCT00327444 ↗Enrolled (actual)
55
Serious AEs
81.8%
Results posted
Jan 2013
Primary outcome: Primary: Time to Repeat Paracentesis (TRP) — 23.3; 55.1 days — p=0.0019
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Sanofi
- Primary completion
- Oct 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Repeat Paracentesis (TRP) |
23.3; 55.1 | 0.0019 sig |
| SECONDARY Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM) |
29.8; 405.3 | 0.0160 sig |
| SECONDARY 60-Day Frequency of Paracentesis (FOP) |
5.1; 2.7 | 0.0035 sig |
| SECONDARY Plasma Levels of Free and VEGF-bound Aflibercept |
69.8; 62.1; 5.33; 5.10; 3.02; 3.49 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00327444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.