Trial of Sunitinib for Refractory Malignant Ascites (NCT00796861) | Clinical Trial Compass
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 range18 Years
SexALL
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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
What they're measuring
1
Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.