TumorNCT01054911
Evaluation of Patients With Bulky GIST Using Sunitinib
A study testing Sunitinib and Surgery in people with Tumor, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Tumor
- What is being tested?
- Sunitinib and Surgery
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2009to Sep 2015
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients more than 19 years old with pathologically proven GIST which is bulky or marginally resectable
- Patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. Bone lesions do not qualify.
- Patients must have an ECOG performance of greater than or equal to 2, with projected survival of at least three months.
- Patients must have adequate laboratory parameters:
- Hematologic: Hb >9.0; WBC >3200 and platelets >100,000/mm3; Hepatic: Bilirubin <2.0 and AST within 4 times upper limit of normal; Renal: Creatinine of less than or equal to 1.6 or eGFR greater than or equal to 50 mL/min
- Men and women who are of childbearing potential must practice strict birth control for the duration of the study.
- Women of childbearing potential must be non-lactating and non-pregnant with a negative pregnancy test within two weeks of trial registration.
- The patient, a witness, and attending physician will have signed an IRB-approved informed consent prior to Sunitinib administration.
Who cannot join
- Known brain metastases or significant pleural effusion or ascites.
- Uncontrolled hypertension, diabetes, or other medical condition.
- Major surgery within 21 days of registration.
- Patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation.
- History of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance.
- Prior therapy for GIST.
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- A history of HIV or hepatitis virus infection.
- Any recent medical condition which, in the opinion of the investigator, makes the patient unsuitable for study participation.
- Patients with impaired kidney function.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35294
About this study
Official title: Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.
Read the detailed description
Gastrointestinal stromal tumor (GIST) is a rare cancer affecting primarily the digestive tract and sometimes abdominal cavity in adults. The most common site is the stomach followed by the duodenum and small intestine.
Surgery is the mainstay of therapy for GIST patients whose primary tumor is felt to be resectable. Prior to the introduction of Gleevec, patients with inoperable GIST had essentially no therapeutic options. However, sunitinib trials offer options to patients who are Gleevec resistant or have intolerant GIST. Clinical benefit has been demonstrated with positive results in several sunitinib studies of varying phases.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SunitinibDrug
Also called SUTENT (Sunitinib)
All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally.
SurgeryProcedure or surgery
Following sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16.
| Study group | Role | What they receive |
|---|---|---|
| Sunitinib pill | Experimental | Patients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16. Receives: Drug: Sunitinib; Procedure: Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events
Measured: 6 months
Secondary outcomes (2)
Measurable Disease Response Rate
Positron electron emission tomography (PET) using 18F-fluorodeoxyglucose (FDG) and computed tomography (CT) will be used. None of the participants were analyzed
Measured: FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12
Alteration in Diffusion and Vascularity Kinetics
The Response Evaluation Criteria in Solid Tumors (RECIST) criteria may be insensitive in assessing GIST so the Choi criteria will be used. The Choi criteria accounts for morphologic tumor changes and biologic alterations. Diffusion-weighted magnetic resonance imaging (MRI) and dynamic contrast magnetic resonance will be used to find the vascular permeability and apparent diffusion coefficient 9ACD) at baseline, Week 2 and Week 6. Weeks 2 and 6 values will be compared to the baseline values using paired t tests.
Measured: MRI at baseline, Week 2 and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2010 (estimated)
- Study startOct 2009
- Primary completionSep 2014
- Study completionSep 2015
Why it stopped: poor 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 TumorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Pfizer
- Responsible party
- Principal investigator, James Posey, MD, University of Alabama at Birmingham
- Investigators
- James A. Posey, M.D., Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01054911
- Sponsor's protocol ID
- F090910001
- Other IDs
- UAB 0855
- Status last verified
- Aug 2016
- First submitted
- 20 Jan 2010
- Last updated
- 22 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Trial of Neoadjuvant Sunitinib in Patients With Bulky GIST
- ClinicalTrials.gov ID
- NCT01054911
- Acronym / sponsor ID
- F090910001
- Conditions
- Tumor
- Keywords
- GIST, gastrointestinal stromal tumor, gastrointestinal stomach tumor, Sunitinib
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: poor accrual
- Enrolment
- 5 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Pfizer
- Study start
- Oct 2009
- Primary completion
- Sep 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 22 Jan 2010 (estimated)
- Results
- Posted 3 Jun 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to determine if oral (mouth) delivery prior to tumor removal in patients with gastrointestinal stromal tumor (GIST) results in tumor shrinkage allowing for successful surgery. Therapy will be administered orally and the response of the tumor will be assessed using CTs or MRIs.
Detailed description
Gastrointestinal stromal tumor (GIST) is a rare cancer affecting primarily the digestive tract and sometimes abdominal cavity in adults. The most common site is the stomach followed by the duodenum and small intestine.
Surgery is the mainstay of therapy for GIST patients whose primary tumor is felt to be resectable. Prior to the introduction of Gleevec, patients with inoperable GIST had essentially no therapeutic options. However, sunitinib trials offer options to patients who are Gleevec resistant or have intolerant GIST. Clinical benefit has been demonstrated with positive results in several sunitinib studies of varying phases.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sunitinib pill | Experimental | Drug: Sunitinib, Procedure: SurgeryPatients will receive six weeks of sunitinib and then subsequently continue for an additional 6 weeks if the evaluation at 6 weeks shows stable disease or objective response. Restaging CT scans will be performed again after 12 weeks of therapy to determine response in preparation for surgical resection anticipated to occur around week 14-16. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients more than 19 years old with pathologically proven GIST which is bulky or marginally resectable
- Patients must have at least one bidimensionally measurable disease site of 5 cm or greater not previously irradiated. Bone lesions do not qualify.
- Patients must have an ECOG performance of greater than or equal to 2, with projected survival of at least three months.
- Patients must have adequate laboratory parameters:
- Hematologic: Hb >9.0; WBC >3200 and platelets >100,000/mm3; Hepatic: Bilirubin <2.0 and AST within 4 times upper limit of normal; Renal: Creatinine of less than or equal to 1.6 or eGFR greater than or equal to 50 mL/min
Key exclusion criteria (9 listed)
- Known brain metastases or significant pleural effusion or ascites.
- Uncontrolled hypertension, diabetes, or other medical condition.
- Major surgery within 21 days of registration.
- Patients wtih organ grafts with the exception of prior high dose chemotherapy with autologous bone marrow (or stem cell) transplantation.
- History of seizures, central nervous system disorders, dementia, or psychosis that might preclude adequate informed consent or protocol compliance.
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: SUTENT (Sunitinib)All patients will receive sunitinib 37.5 mg p.o. daily for up to 12 weeks to be taken orally. | Drug | Sunitinib pill |
| SurgeryFollowing sunitinib therapy, patients will be evaluated for surgery. It is anticipated that the quality of response will allow for complete resection of residual tumor. Surgical resection, if eligible, will occur around week 14-16. | Procedure or surgery | Sunitinib pill |
Primary outcome
Number of Participants With Adverse Events
Time frame: 6 months
2 secondary outcomes
Measurable Disease Response Rate
Time frame: FDG PET scan at baseline and Week 2, CT scan at baseline and Week 12
Alteration in Diffusion and Vascularity Kinetics
Time frame: MRI at baseline, Week 2 and Week 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
James A. Posey, M.D. principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sunitinib and Surgery in people with Tumor, run by University of Alabama at Birmingham 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 8 inclusion and 9 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 22 Sep 2016. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jun 2016). 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?
Number of Participants With Adverse Events (time frame: 6 months). 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 22 Sep 2016.