Clinical Trial: Sorafenib Tosylate in Treating Patients With Metastatic, Locally Advanced, or Recurrent Medullary Thyroid Cancer

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: Phase II Study of Sorafenib (BAY 43-9006) in Patients With Metastatic Medullary Thyroid Carcinoma

Brief Summary: This phase II trial studies how well sorafenib tosylate works in treating patients with medullary thyroid cancer that has spread to other parts of the body (metastatic), spread to the tissue surrounding the thyroid (locally advanced), or has returned after a period of improvement (recurrent). Sorafenib tosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed Summary:

PRIMARY OBJECTIVES:

I. To assess objective response rate of sorafenib (BAY 43-9006) (sorafenib tosylate) in metastatic medullary thyroid carcinoma in setting of inherited tumor syndromes, such as multiple endocrine neoplasia (MEN) 2A, MEN 2B, or familial medullary thyroid carcinoma (FMTC).

II. To assess objective response rate of sorafenib (BAY 43-9006) in sporadic metastatic medullary thyroid carcinoma.

SECONDARY OBJECTIVES:

I. To assess toxicity of sorafenib (BAY 43-9006) in patients with metastatic medullary thyroid carcinoma.

II. Measure serum tumor markers calcitonin and carcinoembryonic antigen (CEA) pre-, during, and post-treatment to correlate with disease response.

II. Correlate nuclear medicine functional imaging (fludeoxyglucose F 18 positron emission tomography [PET] scan) data obtained at pre-, during, and post-treatment with tumor response in these patients.

III. Correlate dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) data obtained at pre-, during, and post-treatment with changes in tumor permeability and vascularity with tumor response.

IV. Perform pharmacogenomic studies on procured peripheral blood mononuclear cells (PBMCs) if clinical responses are observed in these patients.

V. To correlate between the degree of retrovirus-associated deoxyribonucleic acid (DNA) sequences (Ras)-mitogen-activated protein kinase (MAPK) signaling inhibition with vascular endothelial growth factor (VEGF) expression in the tumor and clinical response.

Measured using MRI scans. Determined using Response Evaluation Criteria in Solid Tumors/World Health Organization response criteria. 95% confidence interval will be calculated to estimate the frequency of response.



Original Primary Outcome:

Current Secondary Outcome:

  • Calcitonin levels [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Correlated with disease response.
  • CEA levels [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Correlated with disease response.
  • DCE-MRI data [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Correlated with tumor response.
  • Degree of Ras-MAPK signaling inhibition in the tumor [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Correlated with clinical response.
  • Degree of VEGF expression in the tumor [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Correlated with clinical response.
  • Fludeoxyglucose F-18 PET data [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
    Correlated with tumor response.
  • Incidence of toxicity, graded using the revised National Cancer Institute Common Terminology Criteria for Adverse Events version 3.0 [ Time Frame: Up to 4 weeks after last dose of sorafenib tosylate ]
  • RET gene defects in the tumor [ Time Frame: Baseline ]
    Presence and type will be correlated with clinical response.
  • Selected polymorphisms of genes influencing sorafenib tosylate metabolism and/or resistance genes that may predict response or toxicity [ Time Frame: Baseline ]
    Changes will be correlated with toxicity and clinical response to therapy.


Original Secondary Outcome:

Information By: National Cancer Institute (NCI)

Dates:
Date Received: October 18, 2006
Date Started: October 2006
Date Completion:
Last Updated: February 14, 2017
Last Verified: February 2017