Pilot Study of Intraperitoneal Bevacizumab for the Palliation of Malignant Ascites

Not Applicable

• Conditions: Malignant Ascites; Cancer - Other cancer types

• Registration Number: ACTRN12611000134921
• Lead Sponsor: Palliative Care Research Fund

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2011-02-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Participants must: be at least 18 years of age, have ascites in the setting of documented intra-abdominal malignant disease, have symptoms related to ascites that necessitate paracentesis for symptom control, be English speaking or have an interpreter available, be able to understand and comply with all trial requirements and the implications of off-label use of intraperitoneal bevacizumab, have exhausted all systemic chemotherapy options OR be unfit to receive systemic chemotherapy OR have declined systemic chemotherapy

Exclusion Criteria

Patients will be excluded in the case of: ascites due to non-malignant cause, concurrent treatment with systemic chemotherapy that has a realistic chance of controlling the ascites, concurrent treatment with intravenous bevacizumab, life expectancy of less than 2 weeks, a history of bowel perforation or fistula, symptoms or signs suggestive of bacterial peritonitis, child c cirrhosis, uncontrolled hypertension, surgery within 28 days of treatment, evidence of coagulopathy, symptoms suggestive of bowel obstruction

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy: Paracentesis-free survival.<br>Treatment at each dose will be considered potentially efficacious if the median time to repeat paracentesis is greater than 14 days in at least 3 of 5 patients.<br>Clinical need for repeat paracentesis will be based on patient symptoms, clinical examination and abdominal circumference.[Weekly assessments until patient death or clinical need for repeat paracentesis.]

Secondary Outcome Measures

Name	Time	Method
Toxicity: Adverse events judged possibly or probably related to intraperitoneal bevacizumab infusion.<br><br>Toxicity assessment will include a questionnaire asking about symptoms of: abdominal pain/discomfort, limb swelling or pain, chest pain/dyspnoea, bleeding, headache/neurological symptoms, other. <br>Patients will also have pulse, blood pressure, temperature and oxygen saturations measured.[At baseline, every 4 hours for 24 hours after bevacizumab infusion, then weekly assessments until patient death or clinical need for repeat paracentesis.<br>Patients will also be asked to report symptoms immediately if they develp in between formal assessments.]