The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12611000801910
Ethics application status
Approved
Date submitted
29/07/2011
Date registered
29/07/2011
Date last updated
27/07/2018
Type of registration
Prospectively registered

Titles & IDs
Public title
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
Scientific title
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
Secondary ID [1] 262657 0
ANZGOG-1101
Universal Trial Number (UTN)
Trial acronym
REZOLVE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Advanced chemotherapy resistant gynaecological cancers 268362 0
Ascites 270448 0
Condition category
Condition code
Cancer 268495 268495 0 0
Ovarian and primary peritoneal

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 267002 0
Treatment: Drugs
Comparator / control treatment
not applicable
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269240 0
To demonstrate the potential activity of bevacizumab to reduce the formation or delay the re-accumulation of malignant ascites. This outcome is assessed as the median time from first to second therapeutic ascitic drainage.
Timepoint [1] 269240 0
Six weeks following the second therapeutic ascitic drainage where intraperitoneal bevacizumab is administered
Secondary outcome [1] 279197 0
To evaluate the safety of bevacizumab given via the intra-peritoneal route. This outcome will be assessed as the rates of serious complications including (a) bowel perforations, (b) Grade 3/4 toxicities (by CTCAE V4.0) attributable to bevacizumab).
Timepoint [1] 279197 0
Within three months after the first intraperitoneal administration of bevacizumab
Secondary outcome [2] 279198 0
To evaluate the activity of a second dose of intraperitoneal bevacizumab to reduce the formation or delay the re-accumulation of malignant ascites. This outcome is assessed as the median time from second to third therapeutic ascitic drainage.
Timepoint [2] 279198 0
This outcome assessment will be the date a third therapeutic drainage is performed
Secondary outcome [3] 279199 0
To evaluate changes in the quality of life of women receiving IP bevacuzimab for the treatment of symptomatic ascites using the QLQC30/OV28 validated instruments
Timepoint [3] 279199 0
Within three months after the first intraperitoneal administration of bevacizumab

Eligibility
Key inclusion criteria
1. 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,
2. Age >18 years
3. ECOG 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
Minimum age
18 Years
Maximum age
No limit
Gender
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. 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
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 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 3 months

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
not applicable
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 2072 0
Prince of Wales/Royal Hospital for Women
Recruitment hospital [2] 2073 0
The Royal Women's Hospital - Parkville
Recruitment hospital [3] 2074 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [4] 2075 0
Peter MacCallum Cancer Institute - East Melbourne
Recruitment hospital [5] 3622 0
Mater Adult Hospital - South Brisbane
Recruitment hospital [6] 5393 0
Westmead Hospital - Westmead

Funding & Sponsors
Funding source category [1] 267479 0
University
Name [1] 267479 0
University of Sydney
Address [1] 267479 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [1] 267479 0
Australia
Funding source category [2] 288706 0
Government body
Name [2] 288706 0
Cancer Australia
Address [2] 288706 0
Locked Bag 3 Strawberry Hills NSW 2012
Country [2] 288706 0
Australia
Primary sponsor type
University
Name
University of Sydney
Address
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country
Australia
Secondary sponsor category [1] 266519 0
None
Name [1] 266519 0
Address [1] 266519 0
Country [1] 266519 0
Other collaborator category [1] 252114 0
Other Collaborative groups
Name [1] 252114 0
Australia New Zealand Gynaecological Oncology Group (ANZGOG)
Address [1] 252114 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country [1] 252114 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269442 0
Ethics Review Committee,(RPAH Zone)
Ethics committee address [1] 269442 0
Research Development Office
Royal Prince Alfred Hospital
Camperdown NSW 2050
Ethics committee country [1] 269442 0
Australia
Date submitted for ethics approval [1] 269442 0
01/06/2013
Approval date [1] 269442 0
30/07/2013
Ethics approval number [1] 269442 0

Summary
Brief 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.
Trial website
not applicable
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 32892 0
Dr Katrin Sjoquist
Address 32892 0
NHMRC CTC
Locked Bag 77
CAMPERDOWN NSW 2050
Country 32892 0
Australia
Phone 32892 0
+61 2 9562 5000
Fax 32892 0
+61 2 9562 5094
Email 32892 0
katrin.sjoquist@ctc.usyd.edu.au
Contact person for public queries
Name 16139 0
Mr Hannah Cahill
Address 16139 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 16139 0
Australia
Phone 16139 0
+612 9562 5391
Fax 16139 0
+61 2 9562 5094
Email 16139 0
rezolve@ctc.usyd.edu.au
Contact person for scientific queries
Name 7067 0
Mr Joe Levitt
Address 7067 0
NHMRC Clinical Trials Centre
Locked Bag 77
Camperdown NSW 1450
Country 7067 0
Australia
Phone 7067 0
+612 9562 5391
Fax 7067 0
+61 2 9562 5094
Email 7067 0
rezolve@ctc.usyd.edu.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary