CompletedPhase 2ACTRN12611000801910

A Phase II study to evaluate the safety and potential palliative benefit of intraperitoneal bevacizumab in patients with symptomatic ascites due to advanced chemotherapy resistant gynaecological cancers: REZOLVE


Sponsor

University of Sydney

Enrollment

24 participants

Start Date

Dec 4, 2013

Study Type

Interventional

Conditions

Summary

This study will evaluate the safety and efficacy of intraperitoneal administration (injection into the abdomen) of a drug called bevacizumab in patients with ascites due to advanced chemotherapy resistant gynaecological cancers. Who is it for? You may be eligible join this study if you are a female aged 18 years or more and have symptomatic ascites due to chemotherapy resistant gynaecological cancer. You must have required at least one therapeutic ascitic draining in the 4 weeks prior to study registration. Trial details All participants in this trial will undergo therapeutic draining of malignant ascites as per local institutional protocol. This will then be followed by intraperitoneal administration (injection into the abdomen) of the drug bevacizumab at a dose of 5mg/kg. This treatment may be repeated while on study. Participants will be assessed to determine whether this treatment can reduce the formation of ascites and delay the time to re-accumulation of ascitic fluid. The duration of participation will up to three months after the initial on-study ascitic drainage and bevacizumab infusion.


Eligibility

Sex: FemalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

The REZOLVE study tests whether injecting bevacizumab (a cancer drug) directly into the abdominal cavity can relieve uncomfortable fluid buildup (ascites) in women with advanced, chemotherapy-resistant ovarian, peritoneal, or fallopian tube cancer. Participants must have needed at least one drainage procedure in the past 4 weeks and have an estimated survival of 12 weeks or more.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Therapeutic drainage of malignant ascites per local institutional protocol followed by intraperitoneal administration of bevacizumab (5mg/kg). This intervention may be repeated while on study subject

Therapeutic drainage of malignant ascites per local institutional protocol followed by intraperitoneal administration of bevacizumab (5mg/kg). This intervention may be repeated while on study subject to conditions.


Locations(6)

Prince of Wales/Royal Hospital for Women

NSW,QLD,VIC, Australia

The Royal Women's Hospital - Parkville

NSW,QLD,VIC, Australia

Royal Brisbane & Womens Hospital - Herston

NSW,QLD,VIC, Australia

Peter MacCallum Cancer Institute - East Melbourne

NSW,QLD,VIC, Australia

Mater Adult Hospital - South Brisbane

NSW,QLD,VIC, Australia

Westmead Hospital - Westmead

NSW,QLD,VIC, Australia

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ACTRN12611000801910


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