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Ovarian NeoplasmsPhase 2/3NCT00327444

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

A Phase 2/3 study testing aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in people with Ovarian Neoplasms and Ascites, run by Sanofi at 9 sites in 9 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Neoplasms, Ascites
What is being tested?
aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
58 participants
Where
9 sitesin 9 countries
Study dates
Jul 2006to Oct 2009
Phase
Phase 2/3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
Show all 9Show fewer
  • 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.

Trial locations and contacts

9 sites in 9 countries.

9 sites in 9 countries

United States1 site

  • Sanofi-Aventis Administrative Office

    Bridgewater, New Jersey, 08807

Other trials in United States

Austria1 site

  • Sanofi-Aventis Administrative Office

    Vienna

Other trials in Austria

Belgium1 site

  • Sanofi-Aventis Administrative Office

    Diegem

Other trials in Belgium

Canada1 site

  • Sanofi-Aventis Administrative Office

    Laval

Other trials in Canada

Hungary1 site

  • Sanofi-Aventis Administrative Office

    Budapest

Other trials in Hungary

India1 site

  • Sanofi-Aventis Administrative Office

    Mumbai

Other trials in India

Israel1 site

  • Sanofi-Aventis Administrative Office

    Netanya

Other trials in Israel

Spain1 site

  • Sanofi-Aventis Administrative Office

    Barcelona

Other trials in Spain

United Kingdom1 site

  • Sanofi-Aventis Administrative Office

    Guildford Surrey

Other trials in United Kingdom

About this study

Official title: 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

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.

Read the 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 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
Being tested
aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®), Placebo
Keywords
Ovarian neoplasm, Ascites, Angiogenesis inhibitor, Vascular Endothelial Growth Factor A, Recombinant fusion protein
Medical subject headings
Ovarian Neoplasms, Ascites

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)Drug

    4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.

  • PlaceboDrug

    Placebo was administered intravenously (IV) over 1 hour once every 2 weeks in the DB period.

  • aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)Drug

    4.0 mg/kg aflibercept was administered intravenously (IV) over 1 hour once every 2 weeks in the OL period.

Study groups in NCT00327444
Study groupRoleWhat they receive
PlaceboPlacebo comparatorParticipants with advanced ovarian cancer administered placebo in the double-blind (DB) period. In the open-label (OL) period, participants had the option to receive aflibercept or be withdrawn from the study.
Receives: Drug: Placebo; Drug: aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)
AfliberceptExperimentalParticipants with advanced ovarian cancer administered aflibercept in the double-blind (DB) period. In the open-label (OL) period, participants had the option to continue to receive aflibercept or be withdrawn from the study.
Receives: Drug: aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Repeat Paracentesis (TRP)

    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.

    Measured: From Day 1 up to 6 months from randomization

Secondary outcomes (3)

  1. Area Under the Curve (AUC) for Participant Assessed Ascites Impact Measure (AIM)

    AIM 4 symptoms (abdominal discomfort, abdominal bloating, abdominal pain, and ability to move normally) are scored from 0 to 5, where higher scores represent worst outcomes. An AIM total score ranges from 0-20.

    A plot for (The AIM questionnaire total score - Baseline score) versus time were generated. AIM AUC represents the overall improvement (scored positive) if the area is below the baseline value or worsening (scored negative) if the area is above the baseline. AIM AUC for a participant is the sum of individual areas representing improvement (+) or worsening (-).

    Measured: From Day 1 up to 60 days from randomization to the first postrandomization paracentesis

  2. 60-Day Frequency of Paracentesis (FOP)

    60-Day FOP was defined as the total number of paracenteses performed within the first 60 days after randomization during the double blind treatment period.

    Measured: From Day 1 up to 60 days from randomization

  3. Plasma Levels of Free and VEGF-bound Aflibercept

    Free aflibercept and VEGF-bound aflibercept plasma concentrations were measured by separate enzyme-linked immunosorbent assay (ELISA). The limit of quantitation of free aflibercept was 15.6 ng/mL, and of VEGF-bound aflibercept was 43.9 ng/mL.

    Peak free aflibercept was estimated at the end of Cycle 1 (C1) administration. The median free and VEGF-bound trough concentrations were determined for each participant beyond Cycle 3 (C3), then mean values were estimated from these median values.

    Measured: Following every biweekly treatment administration up to 60 days after treatment discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2006 (estimated)
  2. Study startJul 2006
  3. Primary completionOct 2009
  4. Study completionOct 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
58 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00327444
Sponsor's protocol ID
EFC6125
Other IDs
EudraCT : 2005-005026-31, AVE0005A /3001
Status last verified
Jul 2011
First submitted
16 May 2006
Last updated
1 Jan 2013
Data monitoring committee
Yes

Publications

  • Gaitskell K, Rogozinska E, Platt S, Chen Y, Abd El Aziz M, Tattersall A, Morrison J. Angiogenesis inhibitors for the treatment of epithelial ovarian cancer. Cochrane Database Syst Rev. 2023 Apr 18;4(4):CD007930. doi: 10.1002/14651858.CD007930.pub3.

    PubMed 37185961

  • Gotlieb WH, Amant F, Advani S, Goswami C, Hirte H, Provencher D, Somani N, Yamada SD, Tamby JF, Vergote I. Intravenous aflibercept for treatment of recurrent symptomatic malignant ascites in patients with advanced ovarian cancer: a phase 2, randomised, double-blind, placebo-controlled study. Lancet Oncol. 2012 Feb;13(2):154-62. doi: 10.1016/S1470-2045(11)70338-2. Epub 2011 Dec 20.

    PubMed 22192729

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing aflibercept (ziv-aflibercept, AVE0005, VEGF trap, ZALTRAP®) in people with Ovarian Neoplasms and Ascites, run by Sanofi at 9 sites in 9 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 9 sites in United States, Austria, Belgium, Canada, Hungary and 4 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Jan 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Repeat Paracentesis (TRP) (time frame: From Day 1 up to 6 months from randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00327444, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jan 2013.

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