Trial of Sunitinib for Refractory Malignant Ascites

Ascites Clinical Trial

Official title:

Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00796861
• Other study ID #: PSHCI25224
• Status: Terminated
• Phase: Phase 2
• First received: November 21, 2008
• Last updated: December 19, 2017
• Start date: May 2007
• Est. completion date: April 2011

Study information

• Verified date: December 2017
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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 information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ascites

Intervention

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).

Locations

Country	Name	City	State
United States	Penn State Milton S. Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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