Data

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 dataset

University of Sydney
Access the data

Licence & Rights

DATA SHARING GUIDELINES

Dataset description

This dataset includes 24 female participants (38 86 years old) receiving intraperitoneal bevacizumab recruited into the REZOLVE study from six hospitals in New South Wales, Queensland and Victoria, Australia. Baseline data includes demographics, ECOG performance status, prior systemic treatment, doses of the intervention administered, clinical chemistry, quality of life, adverse events and overall survival. Follow-up data was collected within three months after the first intraperitoneal administration of bevacizumab and includes adverse events and quality of life. The file type is .XLS.
Click to explore relationships graph

Subjects

Oncology

Source Study

Funding

Government body,Cancer Australia

Scientific enquiries

Mr Joe Levitt

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 r ....
Read more

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 ....
Read more

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 unles ....
Read more

Can healthy volunteers participate?

No

 

Population

Sample Size    24

Min. age    18 Years

Max. age    0 No limit

Sex    Females

Condition category    Advanced chemotherapy resistant gynaecological cancers , Ascites

Condition code    Cancer

Intervention

Intervention code Treatment: Drugs

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.

Comparison

Control group Uncontrolled

not applicable

Outcomes

Outcome: 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: Six weeks following the second therapeutic ascitic drainage where intraperitoneal bevacizumab is administered

The data-sharing statement for this study is currently unavailable.

Source study information is derived from the Australian New Zealand Clinical Trials Registry (ANZCTR). For more information on the ANZCTR, please see anzctr.org.au