Trial of Sunitinib for Refractory Malignant Ascites

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.

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