Intraperitoneal bevacizumab for recurrent malignant ascites in chemotherapy resistant solid tumours: a randomised trial (REZOLV3R).

Phase 3

• Conditions: Recurrent malignant ascites; Chemotherapy resistant solid tumours; Cancer - Any cancer

• Registration Number: ACTRN12624000288527
• Lead Sponsor: The University of Sydney

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-20
• Last Update Posted: 5 August 2024

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Patients with symptomatic, cytologically confirmed malignant ascites:
a. who have any solid organ malignancy excluding pancreatic cancer
b. who are either not receiving or not planned to receive additional systemic anticancer treatment for the duration of study treatment
c. that has recurred following at least one therapeutic ascitic drainage within 28 days prior to study registration
d. who require therapeutic paracentesis for symptomatic management
2. Age: 18 years and over
3. Eastern Cooperative Oncology Group (ECOG) performance status 0-3
4. Estimated survival of 12 weeks or more
5. Study treatment both planned and able to start within 14 days of registration
6. Willing and able to comply with all study requirements, including treatment timing and/or nature of required assessments
7. Signed, written informed consent.

Exclusion Criteria

1. At high risk of bowel perforation, including but not limited to any one or more of the following:
a. History of bowel obstruction within 6 months prior to study entry
b. CT scan that demonstrates involvement of bowel by tumour
c. Symptoms to suggest impending bowel obstruction
d. Prior whole abdominal radiotherapy
2. Active or non-healing intra-abdominal fistulae or history of fistulae within previous 60 days
3. Major surgery within the preceding 6 weeks
4. Pulmonary emboli or deep vein thrombosis unless on anticoagulation and no thrombotic episode in the preceding 6 weeks
5. Known bleeding diathesis, or history of active bleeding including known gastric ulceration within 60 days
6. Uncontrolled hypertension, or unstable cardiac disease
7. Concurrent illness, including severe infection that may jeopardize the ability of the patient to undergo the procedures outlined in this protocol with reasonable safety
8. Serious medical or psychiatric conditions that might limit the ability of the patient to comply with the protocol
9. Pregnancy, lactation, or inadequate contraception. Women must be post-menopausal, infertile, or use a reliable means of contraception. Women of childbearing potential must have a negative pregnancy test done within 7 days prior to registration.
10. Previous episode of ascites due to non-malignant causes, for example hepatic failure, portal venous obstruction
11. Known hypersensitivity to or serious reaction resulting from any components of bevacizumab, Chinese hamster ovary cell products or other recombinant human or humanised antibodies
12. Have received anti-VEGF therapy within the last 4 weeks.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare between each treatment group (bevacizumab or control): <br>Post-treatment Paracentesis Free Survival Time (PFST) (First paracentesis on trial (P0) to the earliest of next paracentesis (P1) or death) <br>[Post-treatment Paracentesis Free Survival Time (PFST) as collected from electronic medical records. First paracentesis on trial (P0) to the earliest of next paracentesis (P1) or death.]