Clinical trial NCT00126568 (phase 2, status: terminated)
Conditions: anaplastic thyroid cancer, recurrent thyroid cancer
ICD codes: C73, D34, D44.0, Z85.850
Drugs: sorafenib tosylate
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
Eligibility criteria:

        Criteria:

          -  Progressive disease after prior cytotoxic chemotherapy (i.e., chemotherapy alone or
             combined with radiotherapy)

          -  No symptomatic bulky disease that would impair the airway or impede swallowing (for
             patients with ECOG performance status 2)

          -  No known brain metastases

          -  Measurable or evaluable disease

               -  Measurable disease, defined as ≥ 1 unidimensionally measurable lesion >= 20 mm by
                  conventional techniques OR >= 10 mm by spiral CT scan

               -  Measurable disease not in a previously irradiated field

          -  Patients with evidence of abnormal cardiac conduction (e.g., bundle branch block or
             heart block) are eligible provided disease has been stable for the past 6 months

          -  Performance status:

               -  ECOG 0-2 OR Karnofsky 50-100%

          -  Life expectancy more than 8 weeks

          -  Absolute neutrophil count >= 1,250/mm3

          -  Platelet count >= 100,000/mm3

          -  No evidence of bleeding diathesis

          -  Bilirubin =< 1.5 times upper limit of normal (ULN)

          -  PTT =< 1.5 times ULN

          -  Creatinine =< 1.5 times ULN

          -  No myocardial infarction within the past 6 months

          -  No New York Heart Association class III or IV cardiac disease

          -  No symptomatic congestive heart failure

          -  No unstable angina pectoris

          -  No uncontrolled hypertension (i.e., systolic blood pressure (BP) > 150 mm Hg OR
             diastolic BP > 100 mm Hg)

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  Able to swallow oral medication

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biological composition to sorafenib

          -  No ongoing or active infection

          -  No psychiatric illness or social situation that would preclude study compliance

          -  No other invasive malignancy within the past 5 years except nonmelanoma skin cancer

          -  No other uncontrolled illness

          -  No more than 2 prior systemic cytotoxic chemotherapy regimens (combined modality
             systemic cytoxic chemotherapy is considered 1 prior cytotoxic regimen)

          -  At least 7 days since prior chemotherapy and recovered

          -  At least 7 days since prior radiotherapy and recovered

          -  No prior sorafenib or other inhibitors of MAP kinase signaling intermediates

          -  No prior cancer treatment that would preclude study participation

          -  No concurrent combination antiretroviral therapy for HIV-positive patients

          -  No other concurrent investigational agents

          -  No concurrent cytochrome P450 enzyme-inducing antiepileptic drugs (e.g., phenytoin,
             carbamazepine, or phenobarbital)

          -  No concurrent Hypericum perforatum (St. John's wort) or rifampin

          -  No concurrent therapeutic anticoagulation (concurrent prophylactic anticoagulation
             (i.e., low-dose warfarin) for venous or arterial access devices allowed provided
             requirements for INR and PTT are met)

          -  No other concurrent anticancer therapy

          -  Histologically confirmed anaplastic* thyroid cancer

               -  Not amenable to definitive curative surgery or radiotherapy [Note: *Papillary,
                  follicular, or other histologies that are mixed or identified in a diagnostic
                  tissue sample are allowed provided a high-grade undifferentiated anaplastic
                  component is present ]

          -  No cardiac arrhythmia

          -  AST and ALT =< 3.5 times ULN

          -  INR < 2.0