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Trial of Sunitinib for Refractory Malignant Ascites

Primary Purpose

Ascites

Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Sunitinib
Sponsored by
Milton S. Hershey Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ascites focused on measuring malignant ascites

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Penn State Milton S. Hershey Medical Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Single Arm

Arm Description

Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
November 21, 2008
Last Updated
December 19, 2017
Sponsor
Milton S. Hershey Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00796861
Brief Title
Trial of Sunitinib for Refractory Malignant Ascites
Official Title
Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Phycisican decided to terminate study due to slow patient accrual.
Study Start Date
May 2007 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
April 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ascites
Keywords
malignant ascites

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
4 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Experimental
Arm Description
Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
Intervention Type
Drug
Intervention Name(s)
Sunitinib
Other Intervention Name(s)
Sunitinib malte
Intervention Description
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).
Primary Outcome Measure Information:
Title
Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth.
Description
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.
Time Frame
An average of every 6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leah Cream, MD
Organizational Affiliation
Penn State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Milton S. Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Not enough valuable data

Learn more about this trial

Trial of Sunitinib for Refractory Malignant Ascites

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