A Study of Bevacizumab to Prevent Malignant Ascites

Part of paid clinical trials in Houston, Texas.

Sponsor
Baylor College of Medicine
Study ID
NCT00908219
Phase
PHASE2
Status
Withdrawn

Conditions

  • Malignant Ascites

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bevacizumab — DRUG
    Bevacizumab is given as an IV infusion of 15 mg/kg every three weeks for 12 weeks.

Study Details

The purpose of this study is to determine the effectiveness of using Bevacizumab in the prevention of recurrent malignant ascites. Ascites is a debilitating and unpleasant complication of several types of cancer. Animal and laboratory studies have shown that tumor cell production and/or increases in the amount of Vascular Endothelial Growth Factor (VEGF) is a major cause of the formation of malignant ascites. Therefore, giving patients with malignant ascites a drug that targets and neutralizes VEGF should prevent the recurrence of malignant ascites following paracentesis (a procedure to remove fluid from the abdominal cavity).

Key Dates

First listed
May 25, 2009
Start date
Jul 31, 2009
Status verified
Feb 2012
Primary completion
Feb 28, 2011
Completion
Feb 28, 2011

Study Design

Enrollment
0 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION

Arms

  • Experimental: Bevacizumab IV
    All subjects will be treated with an intravenous infusion of the experimental drug (Bevacizumab 15 mg/kg) every 3 weeks for a total of twelve (12) weeks on study.

Primary Outcome Measure

To determine the repeat paracentesis response rate defined as a doubling of the patient's baseline time to repeat paracentesis. [ Time Frame: 12 weeks after initiation of study treatment ]

Locations (3)

FacilityCityStateZIPSite coordinators
Baylor College of MedicineHoustonTexas77030-
Ben Taub General HospitalHoustonTexas77030-
Michael E. DeBakey Veterans Affairs Medical CenterHoustonTexas77030-

Find similar trials in Houston, TX

By research site
Baylor College of Medicine· Houston, TXBen Taub General Hospital· Houston, TXMichael E. DeBakey Veterans Affairs Medical Center· Houston, TX

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