Nexavar® Versus Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Not Recruiting

Trial ID: NCT00984282

Purpose

Trial of sorafenib versus placebo in the treatment of locally advanced or metastatic differentiated thyroid cancer refractory to radioiodine

Official Title

A Double-Blind Randomized Phase III Study Evaluating the Efficacy and Safety of Sorafenib Compared to Placebo in Locally Advanced/Metastatic RAI-Refractory Differentiated Thyroid Cancer

Stanford Investigator(s)

A. Dimitrios Colevas, MD
A. Dimitrios Colevas, MD

Professor of Medicine (Oncology) and, by courtesy, of Otolaryngology - Head & Neck Surgery (OHNS) and of Radiation Oncology (Radiation Therapy)

Heather Wakelee
Heather Wakelee

Professor of Medicine (Oncology)

Harlan Pinto
Harlan Pinto

Associate Professor of Medicine (Oncology) and of Otolaryngology - Head & Neck Surgery

Eligibility


Inclusion Criteria:

   - Locally advanced or metastatic differentiated thyroid cancer (papillary, follicular
   and Hurthle cell)

   - Poorly differentiated and other thyroid variants (e.g. insular, tall cell, etc.) are
   eligible provided that the histology has no medullary differentiation nor anaplastic
   features

   - Progression within 14 months (RECIST [Response Evaluation Criteria in Solid Tumors]
   should be used as a basis for the assessment of disease progression)

   - RAI (radioactive iodine) refractory

Exclusion Criteria:

   - Histologic subtypes of thyroid cancer other than differentiated (i.e. like anaplastic
   and medullary carcinoma, lymphoma or sarcoma)

   - Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies
   (licensed or investigational) that target VEGF (vascular endothelial growth factor) or
   VEGF Receptors or other targeted agents

   - Prior anti-cancer treatment for thyroid cancer with use of chemotherapy (low dose
   chemotherapy for radiosensitization is allowed) or Thalidomide or any of its
   derivatives

Intervention(s):

drug: Placebo

drug: Sorafenib (Nexavar, BAY43-9006)

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Cancer Clinical Trials Office
650-498-7061

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