Trial of Sunitinib for Refractory Malignant Ascites

This study has been terminated.
(Phycisican decided to terminate study due to slow patient accrual.)
Sponsor:
Information provided by (Responsible Party):
Leah Cream, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier:
NCT00796861
First received: November 21, 2008
Last updated: January 8, 2013
Last verified: January 2013
  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 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites

Resource links provided by NLM:


Further study details as provided by Milton S. Hershey Medical Center:

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 ]

Enrollment: 4
Study Start Date: May 2007
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Single Arm 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).
Other Name: Sunitinib malte

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
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

Locations
United States, Pennsylvania
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Leah Cream, MD Penn State University
  More Information

No publications provided

Responsible Party: Leah Cream, Assistant Professor of Medicine, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT00796861     History of Changes
Other Study ID Numbers: PSHCI25224
Study First Received: November 21, 2008
Last Updated: January 8, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Milton S. Hershey Medical Center:
malignant ascites

Additional relevant MeSH terms:
Ascites
Pathologic Processes
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014