Trial of Sunitinib for Refractory Malignant Ascites

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

Detailed Description
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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.

Official Title
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Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites

Conditions
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Ascites

Intervention / Treatment
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* Drug: Sunitinib


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single Arm<br>Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx | Drug: Sunitinib<br>* Patients will be given Sunitinib 50 mg orally daily for four weeks, followed by a two week holiday. For patients tolerating treatment, three cycles of treatment will be given (18 weeks total).<br>* Other names: Sunitinib malte;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth. | 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. | An average of every 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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malignant ascites