Trial of Sunitinib for Refractory Malignant Ascites - Full Text View

Sponsored by:	Penn State University
Information provided by:	Penn State University
ClinicalTrials.gov Identifier:	NCT00796861

Purpose

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

Condition	Intervention	Phase
Ascites	Drug: Sunitinib	Phase II

Drug Information available for: Sunitinib Sunitinib malate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Official Title:	Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites

Further study details as provided by Penn State University:

Primary Outcome Measures:

Overall response rate where a response is considered to be 3 cm or more decrease in abdominal girth. [ Time Frame: 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 ]

Estimated Enrollment:	37
Study Start Date:	May 2007
Estimated Study Completion Date:	December 2010
Estimated Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Single Arm: Experimental	Drug: Sunitinib 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).

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00796861

Contacts

Contact: Leah Cream, MD

717-531-8870

lcream@hmc.psu.edu

Locations

United States, Pennsylvania
Penn State Milton S. Hershey Medical Center	Recruiting
Hershey, Pennsylvania, United States, 17033
Principal Investigator: Leah Cream, MD

Sponsors and Collaborators

Penn State University

Investigators

Principal Investigator:

Leah Cream, MD

Penn State University

More Information

Responsible Party:	Penn State Milton S. Hershey Medical Center ( Leah Cream, MD )
Study ID Numbers:	PSHCI25224
Study First Received:	November 21, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00796861
Health Authority:	United States: Food and Drug Administration

Keywords provided by Penn State University:

malignant ascites

Study placed in the following topic categories:

Sunitinib
Ascites

Additional relevant MeSH terms:

Pathologic Processes
Antineoplastic Agents
Growth Substances
Therapeutic Uses
Physiological Effects of Drugs

Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 15, 2009