Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent T… (NCT00095693) | Clinical Trial Compass
TerminatedPhase 2
Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
United States25 participantsStarted 2004-10
Plain-language summary
Phase II trial to study the effectiveness of sorafenib tosylate in treating patients who have locally advanced, metastatic, or locally recurrent thyroid cancer. Sorafenib tosylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth and by stopping blood flow to the tumor.
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Histologically confirmed diagnosis of 1 of the following:
* Papillary thyroid cancer (stratum I)
* Papillary, follicular, Hurthle cell, insular, or anaplastic thyroid cancer (stratum II)
* Mixed histology, poorly differentiated, or tall-cell variants allowed
* Metastatic, locally advanced, or locally recurrent disease
* At least 1 unidimensionally measurable lesion \>= 20 mm by conventional techniques OR \>= 10 mm by spiral CT scan
* The following are considered non-measurable disease:
* Tumors in a previously irradiated area
* Bone lesions
* Leptomeningeal disease
* Ascites
* Pleural/pericardial effusion
* Lymphangitis cutis/pulmonis
* Abdominal masses not confirmed and followed by imaging techniques
* Cystic lesions
* Archival tumor tissue block OR material collected before study entry available (stratum I)
* Biopsy-accessible disease (stratum I)
* Performance status - ECOG 0-1
* At least 6 months
* WBC \>= 3,000/mm\^3
* Absolute neutrophil count \>= 1,500/mm\^3
* Platelet count \>= 100,000/mm\^3
* No bleeding diathesis
* Bilirubin =\< 1.5 times upper limit of normal (ULN)
* AST and ALT =\< 1.5 times ULN
* Creatinine =\< 1.5 times ULN
* No uncontrolled hypertension
* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* Willing to undergo 2 tumor biopsies during study participation (stratum I)
* No history of allergic reaction attributed to compounds of sim…