Sorafenib Tosylate in Treating Patients With Locally Advanced, Metastatic, or Locally Recurrent Thyroid Cancer
Stopped early · Phase 2
Conditions studied: Anaplastic Thyroid Cancer, Insular Thyroid Cancer, Recurrent Thyroid Cancer, Stage III Follicular Thyroid Cancer, Stage III Papillary Thyroid Cancer, Stage IV Follicular Thyroid Cancer, Stage IV Papillary Thyroid Cancer
In brief
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.
Key facts
- Study ID
- NCT00095693
- Run by
- National Cancer Institute (NCI)
- People needed
- 25
- Starts
- 2004-10-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2014-01-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Ohio State University Medical Center — Columbus, Ohio, United States
Full record on ClinicalTrials.gov
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