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

Ascites Advanced chemotherapy resistant gynaecological cancers

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

Inclusion Criteria10

Patients with symptomatic, cytologically confirmed malignant ascites;
a. Where ascites is due to histologically confirmed platinum resistant or refractory recurrent epithelial ovarian cancer, peritoneal cancer, or fallopian tube cancer
b. Who have required at least one therapeutic ascitic drainage in the 4 weeks prior to study registration
c. Who are either not receiving or not planned to receive additional systemic chemotherapy,
Age >18 years
ECOG 0-3
Estimated survival of 12 weeks or more
Study treatment both planned and able to start within 14 days of registration.
Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments
Signed, written informed consent

Exclusion Criteria16

At high risk of bowel perforation, including but not limited to any one or more of the following;
a. History of previous bowel obstruction prior to study entry
b. CT scans that suggest involvement of bowel by tumour
c. Symptoms to suggest impending bowel obstruction
d. Prior whole abdominal radiotherapy
Active or non-healing intra-abdominal fistulae or history of fistulae within previous 60 days
Major surgery within the preceding 6 weeks
Pulmonary emboli or deep vein thrombosis unless on anticoagulation and no thrombotic episode in the preceding 6 weeks.
Known bleeding diathesis, or history of active bleeding including known gastric ulceration within 60 days
Uncontrolled hypertension, or unstable cardiac disease
Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol.
Pregnancy, lactation, or inadequate contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
Previous episode of ascites due to non-malignant causes, for example hepatic failure, portal venous obstruction
Known hypersensitivity to or serious reaction resulting from any components of bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanised antibodies,
Have received anti-VEGF therapy within the last 3 months

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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.