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Trial of Sunitinib for Refractory Malignant Ascites

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ClinicalTrials.gov Identifier: NCT00796861
Recruitment Status : Terminated (Phycisican decided to terminate study due to slow patient accrual.)
First Posted : November 24, 2008
Results First Posted : December 20, 2017
Last Update Posted : December 20, 2017
Sponsor:
Information provided by (Responsible Party):
Leah Cream, Milton S. Hershey Medical Center

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

Condition or disease Intervention/treatment Phase
Ascites Drug: Sunitinib Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
Study Start Date : May 2007
Actual Primary Completion Date : April 2011
Actual Study Completion Date : April 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Single Arm
Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx
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



Primary Outcome Measures :
  1. 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 ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: November 24, 2008    Key Record Dates
Results First Posted: December 20, 2017
Last Update Posted: December 20, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Not enough valuable data

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

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