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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

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 Summary:

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.


Sponsor: University of Washington

Current Primary Outcome: Overall Response Rate [ Time Frame: At baseline until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 100 months ]

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.",


Original Primary Outcome: Overall response (complete and partial response) rate based on conventional imaging methods (CT scan; RECIST) and tumor markers

Current Secondary Outcome:

  • 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 treatmentthrough study completion, an average of 2 years ]
    Only adverse events that were grade 3 and higher using NCI Common Toxicity Criteria (CTC) version 3.0 were recorded.
  • 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 ]
    Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.


Original Secondary Outcome:

  • Duration of response
  • Time to progression
  • Overall survival
  • Toxicity
  • Early (7 days) and late (3 months) response rates based on functional imaging (fludeoxyglucose F 18 [FDG]-PET scans, toxicity, and time to tumor progression
  • Comparison of response rates by CT scan vs FDG-PET


Information By: University of Washington

Dates:
Date Received: August 21, 2007
Date Started: July 2007
Date Completion:
Last Updated: March 13, 2017
Last Verified: January 2017