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

NCT ID: NCT00519896

Last Updated: 2017-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31
• Study Completion Date: 2015-09-30

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.

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; Stage IVC Papillary Thyroid Cancer; Thyroid Gland Medullary Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)

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

Group Type: EXPERIMENTAL

sunitinib malate

Intervention Type: DRUG

Given PO

Interventions

sunitinib malate

Given PO

Intervention Type: DRUG

Other Intervention Names

SU11248; sunitinib; Sutent

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Renato Martins

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Renato Martins

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Locations

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, United States

Countries

United States

Other Identifiers

NCI-2011-01305

Identifier Type: REGISTRY

Identifier Source: secondary_id

6494

Identifier Type: -

Identifier Source: org_study_id