Trial of Sunitinib for Refractory Malignant Ascites
- Registration Number
- NCT00796861
- Lead Sponsor
- Milton S. Hershey Medical Center
- Brief Summary
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.
- Detailed 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 4
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Single Arm Sunitinib Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
- Primary Outcome Measures
Name Time Method Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth. An average of every 6 weeks A response will be considered to be 3 cm or more decrease in abdominal girth, or decreased frequency of paracentesis (compared to pre-enrollment). Toxicity monitoring would be the same as that is the expanded access Sutent trial.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Penn State Milton S. Hershey Medical Center
🇺🇸Hershey, Pennsylvania, United States