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

Recurrent Thyroid Cancer Clinical Trial

Official title:

Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00519896
• Other study ID #: 6494
• Secondary ID: NCI-2011-01305
• Status: Completed
• Phase: Phase 2
• First received: August 21, 2007
• Last updated: September 28, 2015
• Start date: July 2007
• Est. completion date: September 2015

Study information

• Verified date: September 2015
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• 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 Diseases
• Thyroid Gland Medullary Carcinoma
• Thyroid Neoplasms

Intervention

Drug:
• sunitinib malate
Given PO

Other:
• laboratory biomarker analysis
Correlative studies

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
University of Washington	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall response rate	A response rate of 20% would be considered favorable and would justify further study. Responses include both complete and partial responses, as defined by RECIST criteria.	At baseline and every 3 months while on study treatment	No
Secondary	Early PET changes		Day 7	No
Secondary	Safety and toxicity of sunitinib malate given as a continuous treatment rated for toxicity using the NCI Common Toxicity Criteria (CTC) version 3.0		On day 1, monthly while on study treatment, and after completion of study treatment	Yes
Secondary	Overall survival		At 30 days from the last dose of study treatment and then for 2 years	No
Secondary	Duration of response measured from the date of the first objective assessment of partial response (PR) or complete response (CR) to the first date of disease relapse or death from any cause		At 30 days from last dose of study treatment and then for 2 years	No
Secondary	Time-to-tumor progression measured from the date of enrollment to the first date of progression of disease		At 30 days from the last dose of study treatment and then for 2 years	No
Secondary	Serial markers thyroglobulin (WDTC) or calcitonin (MTC) during therapy		At baseline, day 7, month 3, and then every 3 months during study treatment	No
Secondary	Correlation of changes in serial tumor markers with radiologic response		At baseline, day 7, month 3, and then every 3 months during study treatment	No