Trial of Sunitinib for Refractory Malignant Ascites

NCT00796861 | Terminated Phase 2 Results DMC

• 1 other identifier: PSHCI25224
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ascites

Keywords

malignant ascites

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Sunitinib

Interventions

Sunitinib DRUG

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).

Also known as: Sunitinib malte

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Ascites

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Dr. Leah Cream
• Organization: Penn State Health

lcream@pennstatehealth.psu.edu

717-531-8870

Study Officials

• Leah Cream, MD

  Penn State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: November 21, 2008
• First Posted: November 24, 2008
• Study Start: May 1, 2007
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: December 20, 2017
• Results First Posted: December 20, 2017

Record last verified: 2017-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)