AscitesPhase 2NCT00796861
Trial of Sunitinib for Refractory Malignant Ascites
A Phase 2 study testing Sunitinib in people with Ascites, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ascites
- What is being tested?
- Sunitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- May 2007to Apr 2011
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
About this study
Official title: Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
The study is to see whether treatment with Sunitinib decreases the accumulation of ascites in patients with refractory malignant ascites.
Read the 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.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called Sunitinib malte
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).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Experimental | Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx Receives: Drug: Sunitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: An average of every 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2008 (estimated)
- Study startMay 2007
- Primary completionApr 2011
- Study completionApr 2011
Why it stopped: Phycisican decided to terminate study due to slow patient accrual.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AscitesStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leah Cream, Milton S. Hershey Medical Center
- Investigators
- Leah Cream, MD, Principal investigator, Penn State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00796861
- Sponsor's protocol ID
- PSHCI25224
- Status last verified
- Dec 2017
- First submitted
- 21 Nov 2008
- Last updated
- 20 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: Not enough valuable data
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Pilot Efficacy Trial of Sunitinib for Refractory Malignant Ascites
- ClinicalTrials.gov ID
- NCT00796861
- Acronym / sponsor ID
- PSHCI25224
- Conditions
- Ascites
- Keywords
- malignant ascites
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Phycisican decided to terminate study due to slow patient accrual.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Study start
- May 2007
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 24 Nov 2008 (estimated)
- Results
- Posted 20 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Experimental | Drug: SunitinibSunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SunitinibAlso: Sunitinib maltePatients 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). | Drug | Single Arm |
Primary outcome
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. Not enough valuable data
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Leah Cream, MD principal investigator
Penn State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Sunitinib in people with Ascites, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2017.