TerminatedPhase 1

Feasibility Study of Intraperitoneal Bevacizumab for Palliation of Intractable Malignant Ascites

Stopped: Lack of Enrollment

United States10 participantsStarted 2015-06

Plain-language summary

This study will evaluate the safety and efficacy of intraperitoneal administration of Bevacizumab to prevent the recurrence of malignant ascites. Ten patients will receive intraperitoneal Bevacizumab 200 mg in 250 ml of normal saline for infusion every two weeks for up to six weeks, or a maximum of three treatments.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patients will be included in the case of: * Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≤ 2 * Participants must be 18 years of age or older * Have ascites of malignant disease * Have symptoms related to ascites * Ascites Index above 0.05 (AI ˃ 0.05) * Be an English speaking patient or have an interpreter available * Be able to understand and comply with all study requirements and the implications of off-label use of intraperitoneal Bevacizumab * Have had at least two paracentesis within the last 4 weeks 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 intraperitoneal Bevacizumab * life expectancy of less than 2 weeks * A history of bowel perforation or fistula * Symptoms or signs suggestive of bacterial peritonitis * Child's C cirrhosis * Uncontrolled hypertension * Surgery within 28 days of catheter treatment * Evidence of coagulopathy * Symptoms suggestive of bowel obstruction * Major surgery, open biopsy or significant traumatic injury within seven (7) days of first study drug--including neurosurgery. * Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements. * Concurrent severe illness such as active infection, or psychiatric illness/social s…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Radiographic Improvement

Timeframe: 14 days (+/-4 days)

Volume Output

Timeframe: 14 days (+/-4 days)

Trial details

NCT IDNCT02496286

SponsorEastern Regional Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2015-08

View on ClinicalTrials.gov More Malignant Ascites trials