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A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks in Advanced Ovarian Cancer Patients With Recurrent Symptomatic Malignant Ascites


Phase 2/Phase 3
18 Years
N/A
Not Enrolling
Female
Ovarian Neoplasms, Ascites

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Trial Information

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-arm Study of the Effect of Intravenous Aflibercept Administered Every 2 Weeks 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:

1. Participant or his legally authorized representative request discontinuation

2. 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

3. Sponsor request

4. Intercurrent illness that prevented further administration of investigational
product(IP)

5. More than 2 IP dose reductions

6. Unacceptable adverse events (AE) not manageable by symptomatic therapy, dose delay, or
dose modification

7. Arterial thromboembolic events, including cerebrovascular accidents, myocardial
infarctions, transient ischemic attacks, new onset or worsening of preexisting angina

8. 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

Time to Repeat Paracentesis (TRP)

Outcome Description:

TRP was defined as the number of days between the date of randomization and the date of the first post-randomization paracentesis. For participants who did not undergo a postrandomization paracentesis on study, TRP was calculated from randomization to the end of the double-blind treatment period.

Outcome Time Frame:

From Day 1 up to 6 months from randomization

Safety Issue:

No

Principal Investigator

Walter GOTLIEB

Investigator Role:

Principal Investigator

Investigator Affiliation:

Director of Gynecologic Oncology and Colposcopy Associate Professor of Oncology, McGill University - Montreal - Quebec Canada

Authority:

United States: Food and Drug Administration

Study ID:

EFC6125

NCT ID:

NCT00327444

Start Date:

July 2006

Completion Date:

October 2009

Related Keywords:

  • Ovarian Neoplasms
  • Ascites
  • Ovarian neoplasm
  • Ascites
  • Angiogenesis inhibitor
  • Vascular Endothelial Growth Factor A
  • Recombinant fusion protein
  • Ascites
  • Neoplasms
  • Ovarian Neoplasms

Name

Location

Sanofi-Aventis Administrative OfficeBridgewater, New Jersey  08807