Trial of Sunitinib for Refractory Malignant Ascites

Penn State Health

Status and phase

Terminated

Phase 2

Conditions

Ascites

Treatments

Drug: Sunitinib

Study type

Interventional

Funder types

Other

Identifiers

NCT00796861

PSHCI25224

Details and patient eligibility

About

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

Full description

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.

Enrollment

4 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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