Recurrent Thyroid CancerPhase 2NCT00519896
Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
A Phase 2 study testing sunitinib malate in people with Recurrent Thyroid Cancer and Stage IVA Follicular Thyroid Cancer, run by University of Washington at 1 site in United States.
Trial summary
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer
- What is being tested?
- sunitinib malate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Sep 2015
- 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
- Histologically or cytologically proven metastatic WDTC or MTC
- Evidence of refractoriness to iodine therapy for WDTC documented by a combination of imaging and thyroglobulin or by biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- Evidence of fludeoxyglucose F 18 (FDG) PET avid metastatic tumors
- Measurable disease by RECIST criteria
- Resolution of all acute toxic effects of prior systemic therapy (including iodine therapy or chemotherapy), radiotherapy or surgical procedure to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 grade =< 1
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- Total serum bilirubin =< 1.5 x upper limit of normal (ULN) (patients with Gilbert's disease exempt)
- Serum transaminases =< 2.5 x ULN or =< 5.0 X ULN if secondary to liver metastases
- Serum creatinine =< 1.5 x ULN
- Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
- Platelets >= 100,000/uL
- Hemoglobin >= 9.0 g/dL
- Willingness and ability to comply with scheduled visits, treatment plans and laboratory tests and other study procedures
- Male and female patients with reproductive potential must use an acceptable contraceptive method
- Signed and dated informed consent document indicating that the patient has been informed of all the pertinent aspects of the trial prior to enrollment
Who cannot join
- Concomitant treatment in another therapeutic clinical trial
- ECOG performance status >= 3
- Symptomatic, untreated, brain metastasis
- Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
- Full-dose anticoagulation defined as:
- Low molecular weight heparin use with the intent of full dose anticoagulation; example: enoxaparin 1.5 mg/kg daily or equivalent
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- Warfarin use to keep international normalized ratio (INR) greater than or equal to 2
- History of gross hemoptysis (defined as bright red blood of at least 1/2 teaspoon or 2.5 mL per episode) within 3 months prior to study drug administration unless definitively treated with surgery or radiation
- Any of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident or transient ischemic attack, or pulmonary embolism; ongoing cardiac dysrhythmias of NCI CTCAE Version 3.0 grade >= 2
- Type I Diabetes Mellitus; patients with Type II Diabetes Mellitus will be included as long as their glucose can be controlled between levels of 80 and 150 mg/dL
- Uncontrolled Hypertension (> 150/100 mm Hg despite optimal medical therapy)
- Major surgery or radiation therapy within 4 weeks of starting the study treatment
- Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
- Pregnancy or breast feeding
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor
Read the detailed description
PRIMARY OBJECTIVES:
- Evaluate the response of sunitinib (sunitinib malate) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with recurrent/metastatic iodine refractory well differentiated thyroid carcinoma (WDTC) or medullary thyroid carcinoma (MTC).
SECONDARY OBJECTIVES:
- Evaluate early positron emission tomography (PET) changes in patients with WDTC and MTC treated with sunitinib.
II. Determine the safety and toxicity of sunitinib given as a continuous treatment in patients with WDTC and MTC.
III. Evaluate the effect of sunitinib therapy on overall survival, duration of response and time-to-progression.
IV. Evaluate serial tumor markers, thyroglobulin (WDTC) or calcitonin (MTC), during therapy. These measurements will not be used to define disease progression or response.
- Correlate changes in serial tumor markers with radiologic response.
OUTLINE:
Patients receive sunitinib malate orally (PO) once daily (QD). Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then for 2 years.
- Conditions
- Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer, Stage IVB Follicular Thyroid Cancer, Stage IVB Papillary Thyroid Cancer, Stage IVC Follicular Thyroid Cancer
- Being tested
- sunitinib malate
- Medical subject headings
- Thyroid Neoplasms, Adenocarcinoma, Follicular, Thyroid Cancer, Papillary, Carcinoma, Medullary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sunitinib malateDrug
Also called SU11248, sunitinib, Sutent
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Treatment (enzyme inhibitor therapy, antiangiogenesis therapy) | Experimental | Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. Receives: Drug: sunitinib malate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
Measured: At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Secondary outcomes (2)
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0
Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.
Measured: On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years
Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease
Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Measured: At 30 days from the last dose of study treatment and then for 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2007 (estimated)
- Study startJul 2007
- Primary completionMay 2015
- Study completionSep 2015
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 Recurrent Thyroid CancerStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Renato Martins, University of Washington
- Investigators
- Renato Martins, Principal investigator, Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00519896
- Sponsor's protocol ID
- 6494
- Other IDs
- NCI-2011-01305
- Status last verified
- Jan 2017
- First submitted
- 21 Aug 2007
- Last updated
- 25 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
- ClinicalTrials.gov ID
- NCT00519896
- Acronym / sponsor ID
- 6494
- Conditions
- Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer, Stage IVB Follicular Thyroid Cancer, Stage IVB Papillary Thyroid Cancer, Stage IVC Follicular Thyroid Cancer
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2007
- Primary completion
- May 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 23 Aug 2007 (estimated)
- Results
- Posted 25 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase II trial studies how well giving sunitinib malate works in treating patients with iodine-refractory recurrent or metastatic thyroid cancer. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth or by blocking blood flow to the tumor
Detailed description
PRIMARY OBJECTIVES:
- Evaluate the response of sunitinib (sunitinib malate) per Response Evaluation Criteria in Solid Tumors (RECIST) criteria in patients with recurrent/metastatic iodine refractory well differentiated thyroid carcinoma (WDTC) or medullary thyroid carcinoma (MTC).
SECONDARY OBJECTIVES:
- Evaluate early positron emission tomography (PET) changes in patients with WDTC and MTC treated with sunitinib.
II. Determine the safety and toxicity of sunitinib given as a continuous treatment in patients with WDTC and MTC.
III. Evaluate the effect of sunitinib therapy on overall survival, duration of response and time-to-progression.
IV. Evaluate serial tumor markers, thyroglobulin (WDTC) or calcitonin (MTC), during therapy. These measurements will not be used to define disease progression or response.
- Correlate changes in serial tumor markers with radiologic response.
OUTLINE:
Patients receive sunitinib malate orally (PO) once daily (QD). Treatment continues in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up at 30 days and then for 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (enzyme inhibitor therapy, antiangiogenesis therapy) | Experimental | Drug: sunitinib malatePatients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Histologically or cytologically proven metastatic WDTC or MTC
- Evidence of refractoriness to iodine therapy for WDTC documented by a combination of imaging and thyroglobulin or by biopsy
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 3
- Evidence of fludeoxyglucose F 18 (FDG) PET avid metastatic tumors
- Measurable disease by RECIST criteria
Key exclusion criteria (14 listed)
- Concomitant treatment in another therapeutic clinical trial
- ECOG performance status >= 3
- Symptomatic, untreated, brain metastasis
- Second primary malignancy that is clinically detectable or clinically significant at the time of consideration for study enrollment
- Full-dose anticoagulation defined as:
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 |
|---|---|---|
| sunitinib malateAlso: SU11248, sunitinib, SutentGiven PO | Drug | Treatment (enzyme inhibitor therapy, antiangiogenesis therapy) |
Primary outcome
Overall Response Rate
Time frame: At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.",
2 secondary outcomes
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0
Time frame: On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years
Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease
Time frame: At 30 days from the last dose of study treatment and then for 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
- 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.
Renato Martins principal investigator
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
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 malate in people with Recurrent Thyroid Cancer and Stage IVA Follicular Thyroid Cancer, run by University of Washington 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 15 inclusion and 14 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: finished, as of the sponsor's last update on 25 Apr 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 25 Apr 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 (time frame: At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 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 25 Apr 2017.