Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer (NCT00654238) | Clinical Trial Compass
CompletedPhase 2
Phase II Trial of Sorafenib (Nexavar) in Patients With Advanced Thyroid Cancer
United States59 participantsStarted 2006-02
Plain-language summary
The goal of this study is to determine the activity of sorafenib in patients with advanced (metastatic or recurrent) thyroid cancer.
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:
* Patients must have histologically confirmed thyroid cancer that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.
* Patients may have received multiple treatments of radioactive iodine, one prior biologic treatment, and at least half of the patients will have had no prior chemotherapy for metastatic disease. At least 3 weeks must have elapsed since prior treatment.
* Measurable disease defined as at least one malignant lesion that can be accurately and serially measured in at least one dimension (longest diameter to be recorded), using a caliper (diameter \> 10 mm) for superficial cutaneous disease, or using contrast-enhanced CT or spiral CT (diameter \> 20 mm) for visceral or nodal/soft tissue disease.
* ECOG performance status \< 2 (Appendix 1).
* Life expectancy greater than 3 months.
* Adequate organ function that has been determined within 7 days prior to enrollment, defined as:Leucocyte count \> 3,000/uL; Absolute neutrophil count (ANC) \> 1,500/mm3, platelets \> 100,000/mm3, and hemoglobin \> 9 g/dl; Serum creatinine \< 1.5 times ULN, or 24-hour creatinine clearance \> 75 cc/min. (Note: creatinine clearance need not be determined if the baseline serum creatinine is within normal limits); Serum bilirubin \< 1.5 times ULN; serum glutamyloxaloacetic transaminase (SGOT) \< 2.5 ULN; alkaline phosphatase \< 2.5 times ULN; PT-INR/PTT \< 1.5 x upper limit of normal.
* Intellectua…
What they're measuring
1
To Determine the Efficacy (Best Response) of BAY 43-9006 (Objective Response Rate and Stable Disease) in Patients With Metastatic Thyroid Carcinoma.
Timeframe: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 60 months