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

Conditions

• Ascites
• Ovarian Neoplasms

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• 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.
• Placebo — DRUG
  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 Details

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.

Key Dates

Start date

Jul 31, 2006

Status verified

Jul 2011

Primary completion

Oct 31, 2009

Completion

Oct 31, 2009

Study Design

Enrollment

58 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  Participants 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 In the open-label (OL) period, participants had the option to receive aflibercept or be withdrawn from the study.
• Experimental: Aflibercept
  Participants 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 In the open-label (OL) period, participants had the option to continue to receive aflibercept or be withdrawn from the study.

Primary Outcome Measure

Time to Repeat Paracentesis (TRP) [ Time Frame: From Day 1 up to 6 months from randomization ]

Locations (1)

Find similar trials in Bridgewater, NJ

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