Trial of Sunitinib for Refractory Malignant Ascites
This study has been terminated.
(Phycisican decided to terminate study due to slow patient accrual.)
Information provided by (Responsible Party):
Leah Cream, Milton S. Hershey Medical Center
First received: November 21, 2008
Last updated: January 8, 2013
Last verified: January 2013
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.
||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
Primary Outcome Measures:
- Overall response rate where a response is considered to be 3 cm or more decrease in abdominal girth. [ Time Frame: An average of every 6 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Understand the mechanism of VEGF inhibition in ascites, using paracentesis samples. [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||April 2011 (Final data collection date for primary outcome measure)
Experimental: Single Arm
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).
Other Name: Sunitinib malte
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00796861
|Penn State Milton S. Hershey Medical Center
|Hershey, Pennsylvania, United States, 17033 |
Milton S. Hershey Medical Center
||Leah Cream, MD
||Penn State University
No publications provided
||Leah Cream, Assistant Professor of Medicine, Milton S. Hershey Medical Center
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 21, 2008
||January 8, 2013
||United States: Food and Drug Administration
Keywords provided by Milton S. Hershey Medical Center:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on October 19, 2014
Angiogenesis Modulating Agents
Physiological Effects of Drugs