Status:
TERMINATED
Trial of Sunitinib for Refractory Malignant Ascites
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Ascites
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 draina...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2011
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00796861
Start Date
May 1 2007
End Date
April 1 2011
Last Update
December 20 2017
Active Locations (1)
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1
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033