Trial of Sunitinib for Refractory Malignant Ascites
Study Details
Study Description
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 |
|---|---|---|
| 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 Design
Arms and Interventions
| 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 Names:
|
Outcome Measures
Primary Outcome Measures
- Overall Response Rate Where a Response is Considered to be 3 cm or More Decrease in Abdominal Girth. [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.
Eligibility Criteria
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
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PSHCI25224
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx 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). |
| Period Title: Overall Study | |
| STARTED | 4 |
| COMPLETED | 0 |
| NOT COMPLETED | 4 |
Baseline Characteristics
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx 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). |
| Overall Participants | 4 |
| Age (Count of Participants) | |
| <=18 years |
0
0%
|
| Between 18 and 65 years |
3
75%
|
| >=65 years |
1
25%
|
| Sex: Female, Male (Count of Participants) | |
| Female |
1
25%
|
| Male |
3
75%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
0
0%
|
| Not Hispanic or Latino |
4
100%
|
| Unknown or Not Reported |
0
0%
|
| Race (NIH/OMB) (Count of Participants) | |
| American Indian or Alaska Native |
0
0%
|
| Asian |
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
| Black or African American |
0
0%
|
| White |
4
100%
|
| More than one race |
0
0%
|
| Unknown or Not Reported |
0
0%
|
Outcome Measures
| 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 |
Outcome Measure Data
| Analysis Population Description |
|---|
| No analyses were performed as none of the subjects made it through a full cycle. |
| Arm/Group Title | Single Arm |
|---|---|
| Arm/Group Description | Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx 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). |
| Measure Participants | 0 |
Adverse Events
| Time Frame | ||
|---|---|---|
| Adverse Event Reporting Description | 1 subject withdrew consent before beginning treatment; only 3 subjects participated in treatment. | |
| Arm/Group Title | Single Arm | |
| Arm/Group Description | Sunitinib (50mg PO daily x 4 wks + 2 wks rest x 3 cycles if able to tolerate tx 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). | |
All Cause Mortality |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | |
Serious Adverse Events |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 0/3 (0%) | |
Other (Not Including Serious) Adverse Events |
||
| Single Arm | ||
| Affected / at Risk (%) | # Events | |
| Total | 3/3 (100%) | |
| Gastrointestinal disorders | ||
| Constipation | 1/3 (33.3%) | 1 |
| General disorders | ||
| Weakness | 1/3 (33.3%) | 1 |
| Nausea | 2/3 (66.7%) | 4 |
| Fatigue | 1/3 (33.3%) | 1 |
| Vomiting | 2/3 (66.7%) | 3 |
| Decreased appetite | 1/3 (33.3%) | 1 |
| Insomnia | 1/3 (33.3%) | 1 |
| Tremors | 1/3 (33.3%) | 1 |
| Feeling cold | 1/3 (33.3%) | 1 |
| UTI | 1/3 (33.3%) | 1 |
| Anorexia | 1/3 (33.3%) | 1 |
| Hyponatremia | 1/3 (33.3%) | 1 |
| Hyperkalemia | 2/3 (66.7%) | 2 |
| Hypocalcemia | 2/3 (66.7%) | 2 |
| Decreased Albumin level | 1/3 (33.3%) | 1 |
| Hypoglycemia | 2/3 (66.7%) | 2 |
| Increased Hemoglobin count | 1/3 (33.3%) | 1 |
| Decreased white blood cell count | 1/3 (33.3%) | 1 |
| Decreased platelet count | 1/3 (33.3%) | 1 |
| Hepatobiliary disorders | ||
| Increased aspartate aminotransferase (AST) level | 1/3 (33.3%) | 1 |
| Renal and urinary disorders | ||
| Increased creatinine level | 1/3 (33.3%) | 1 |
| Urinary retention | 1/3 (33.3%) | 1 |
| Skin and subcutaneous tissue disorders | ||
| Erythematous macular erruption | 1/3 (33.3%) | 1 |
| Stenotrophomas (3+) lesion right thigh | 1/3 (33.3%) | 1 |
| Dry skin | 1/3 (33.3%) | 1 |
| Skin ulcers | 1/3 (33.3%) | 1 |
| Labial exoriation | 1/3 (33.3%) | 1 |
| Ulcer | 1/3 (33.3%) | 4 |
| Fissures | 1/3 (33.3%) | 2 |
Limitations/Caveats
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
| Name/Title | Dr. Leah Cream |
|---|---|
| Organization | Penn State Health |
| Phone | 717-531-8870 |
| lcream@pennstatehealth.psu.edu |
- PSHCI25224