TerminatedPhase 2

Trial of Sunitinib for Refractory Malignant Ascites

Stopped: Phycisican decided to terminate study due to slow patient accrual.

United States4 participantsStarted 2007-05

Plain-language summary

The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.

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: * Solid tumor malignancy and failure of at least one biologic or cytotoxic regimen, or the inability to receive standard treatment due to performance status (PS\>2). * Ascites based on paracentesis or CT scan within one month prior to enrollment * Life expectancy \> 3 months * Indwelling paracentesis catheters are permitted, paracentesis is permitted at the investigators discretion * Negative urine pregnancy test for females * All subjects must agree to use birth control * All subjects must abstain from eating grapefruit and grapefruit juice. They must tell their physicians about any changes in their medication including over-the-counter and herbal supplements. Exclusion Criteria: * History of congestive heart failure * Creatinine \> 2.0 * Pregnant or nursing * ALT \> 2.5 times the upper limit of normal * Blood pressure \> 160/90 (antihypertensives permitted) * Gastrointestinal or intra-abdominal hemorrhage within the last 6 months * History of QTc \> 450 milliseconds * Brain metastasis

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

Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.

Timeframe: An average of every 6 weeks

Trial details

NCT IDNCT00796861

SponsorMilton S. Hershey Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2011-04

Results submitted2017-08-22

View on ClinicalTrials.gov More Ascites trials

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.