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
University of Sydney
24 participants
Dec 4, 2013
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
Plain Language Summary
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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 to conditions.
Locations(6)
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ACTRN12611000801910