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

NCT00519896 | Completed Phase 2 Results

• 2 other identifiers: 6494NCI-2011-01305
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• 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.",

  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

  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

  At 30 days from the last dose of study treatment and then for 2 years

Study Arms (1)

Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)

EXPERIMENTAL

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

Drug: sunitinib malate

Interventions

sunitinib malate DRUG

Given PO

Also known as: SU11248, sunitinib, Sutent

Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Washington: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Adenocarcinoma, Follicular; Thyroid Cancer, Papillary; Carcinoma, Medullary

Interventions

Sunitinib

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Adenocarcinoma, Papillary; Carcinoma, Neuroendocrine; Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Ductal, Lobular, and Medullary; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Renato G Martins
• Organization: University of Washington

rgmart@uw.edu

206-288-2048

Study Officials

• Renato Martins

  Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 21, 2007
• First Posted: August 23, 2007
• Study Start: July 1, 2007
• Primary Completion: May 1, 2015
• Study Completion: September 1, 2015
• Last Updated: April 25, 2017
• Results First Posted: April 25, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)