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Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer

Primary Purpose

Recurrent Thyroid Cancer, Stage IVA Follicular Thyroid Cancer, Stage IVA Papillary Thyroid Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
sunitinib malate
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Recurrent Thyroid Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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
  • 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

Exclusion Criteria:

  • 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
    • 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

Sites / Locations

  • Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)

Arm Description

Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.

Outcomes

Primary Outcome Measures

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.",

Secondary Outcome Measures

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.
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.

Full Information

First Posted
August 21, 2007
Last Updated
March 13, 2017
Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00519896
Brief Title
Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer
Official Title
Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
July 2007 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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
Detailed Description
PRIMARY OBJECTIVES: I. 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: I. 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. V. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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, Stage IVC Papillary Thyroid Cancer, Thyroid Gland Medullary Carcinoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)
Arm Type
Experimental
Arm Description
Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Intervention Type
Drug
Intervention Name(s)
sunitinib malate
Other Intervention Name(s)
SU11248, sunitinib, Sutent
Intervention Description
Given PO
Primary Outcome Measure Information:
Title
Overall Response Rate
Description
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.",
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
Secondary Outcome Measure Information:
Title
Safety and Toxicity of Sunitinib Malate Given as a Continuous Treatment Rated for Toxicity Using the NCI Common Toxicity Criteria (CTC) Version 3.0
Description
Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.
Time Frame
On day 1, monthly while on study treatment, and after completion of study treatmentthrough study completion, an average of 2 years
Title
Time-to-tumor Progression Measured From the Date of Enrollment to the First Date of Progression of Disease
Description
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.
Time Frame
At 30 days from the last dose of study treatment and then for 2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 Exclusion Criteria: 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renato Martins
Organizational Affiliation
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Sunitinib Malate in Treating Patients With Iodine-Refractory Recurrent or Metastatic Thyroid Cancer

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