Expired Study
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Hershey, Pennsylvania 17033


Purpose:

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


Study summary:

This is a single arm, non-randomized, phase II pilot study in patients who have stopped cytotoxic and biologic therapy for their neoplasms and are suffering from malignant ascites that requires drainage for comfort. The study will employ a Simon 2-stage optimal design. Initially up to 17 patients would be enrolled. If there are no responses among the first 12 patients, the study would be terminated. Otherwise the trial would be expanded by 23 to a total of 37 patients. If there are 3 or fewer responses by the end of the trial, then no further investigation would be warranted.


Criteria:

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


NCT ID:

NCT00796861


Primary Contact:

Principal Investigator
Leah Cream, MD
Penn State University


Backup Contact:

N/A


Location Contact:

Hershey, Pennsylvania 17033
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: October 09, 2019

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