Trial of Sunitinib for Refractory Malignant Ascites

• Status: Terminated
• Trial end date: 2011-04-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Milton S. Hershey Medical Center
• Treatments: Sunitinib

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