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

University of Washington

Status and phase

Completed

Phase 2

Conditions

Recurrent Thyroid Cancer

Stage IVC Follicular Thyroid Cancer

Stage IVC Papillary Thyroid Cancer

Stage IVB Follicular Thyroid Cancer

Stage IVA Papillary Thyroid Cancer

Stage IVA Follicular Thyroid Cancer

Thyroid Gland Medullary Carcinoma

Stage IVB Papillary Thyroid Cancer

Treatments

Drug: sunitinib malate

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00519896

NCI-2011-01305 (Registry Identifier)

6494

Details and patient eligibility

About

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

Full 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.

Enrollment

35 patients

Sex

All

Ages

18+ years old

Volunteers

No 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