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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Washington
ClinicalTrials.gov Identifier:
NCT00519896
First received: August 21, 2007
Last updated: May 5, 2014
Last verified: May 2014
  Purpose

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


Condition Intervention Phase
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
Drug: sunitinib malate
Other: laboratory biomarker analysis
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Sunitinib in Iodine Refractory Differentiated Thyroid Cancer and Metastatic Medullary Carcinoma of Thyroid With Functional Imaging Correlation

Resource links provided by NLM:


Further study details as provided by University of Washington:

Primary Outcome Measures:
  • Overall response rate [ Time Frame: At baseline and every 3 months while on study treatment ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Early PET changes [ Time Frame: Day 7 ] [ Designated as safety issue: No ]
  • Safety and toxicity of sunitinib malate given as a continuous treatment rated for toxicity using the NCI Common Toxicity Criteria (CTC) version 3.0 [ Time Frame: On day 1, monthly while on study treatment, and after completion of study treatment ] [ Designated as safety issue: Yes ]
  • Overall survival [ Time Frame: At 30 days from the last dose of study treatment and then for 2 years ] [ Designated as safety issue: No ]
  • 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 [ Time Frame: At 30 days from last dose of study treatment and then for 2 years ] [ Designated as safety issue: No ]
  • Time-to-tumor progression measured from the date of enrollment to the first date of progression of disease [ Time Frame: At 30 days from the last dose of study treatment and then for 2 years ] [ Designated as safety issue: No ]
  • Serial markers thyroglobulin (WDTC) or calcitonin (MTC) during therapy [ Time Frame: At baseline, day 7, month 3, and then every 3 months during study treatment ] [ Designated as safety issue: No ]
  • Correlation of changes in serial tumor markers with radiologic response [ Time Frame: At baseline, day 7, month 3, and then every 3 months during study treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 35
Study Start Date: July 2007
Estimated Primary Completion Date: May 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (enzyme inhibitor therapy, antiangiogenesis therapy)
Patients receive sunitinib malate PO QD. Treatment continues in the absence of disease progression or unacceptable toxicity.
Drug: sunitinib malate
Given PO
Other Names:
  • SU11248
  • sunitinib
  • Sutent
Other: laboratory biomarker analysis
Correlative studies

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00519896

Locations
United States, Washington
Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109
Sponsors and Collaborators
University of Washington
Investigators
Principal Investigator: Renato Martins Fred Hutchinson Cancer Research Center/University of Washington Cancer Consortium
  More Information

No publications provided

Responsible Party: University of Washington
ClinicalTrials.gov Identifier: NCT00519896     History of Changes
Other Study ID Numbers: 6494, NCI-2011-01305
Study First Received: August 21, 2007
Last Updated: May 5, 2014
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Carcinoma
Thyroid Neoplasms
Thyroid Diseases
Adenocarcinoma, Follicular
Carcinoma, Medullary
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Endocrine System Diseases
Adenocarcinoma
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Nerve Tissue
Sunitinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors

ClinicalTrials.gov processed this record on July 22, 2014