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A Randomized Phase II Study of Concurrent Intensity Modulated Radiation Therapy (IMRT), Paclitaxel and Pazopanib (NSC 737754)/Placebo, for the Treatment of Anaplastic Thyroid Cancer

Primary Objective for Run-In Components To evaluate the safety of IMRT, paclitaxel, and pazopanib suspension Primary Objective for Phase II Component To evaluate and compare overall survival at 1 year from study registration Secondary Objectives for Phase II Component To evaluate local-regional control at 6 and 12 months; To evaluate the rate of grade 4 (CTCAE, v. 4.0) hemorrhage, grade 4 febrile neutropenia, or any Grade 5 adverse event assessed to be definitely, probably, or possibly related to the induction or concurrent treatment components of the protocol regimen; To evaluate the rates of other adverse events (CTCAE, v. 4.0) assessed to be definitely, probably, or possibly related to the induction or concurrent treatment components of the protocol regimen; To evaluate the rate of treatment discontinuation due to toxicity during the induction or concurrent treatment components of the protocol regimen; To evaluate response (as per RECIST) of the primary site following the treatment component in subjects with measurable disease prior to chemoradiation.

Primary Objective for Run-In Components To evaluate the safety of IMRT, paclitaxel, and pazopanib suspension Primary Objective for Phase II Component To evaluate and compare overall survival at 1 year from study registration Secondary Objectives for Phase II Component To evaluate local-regional control at 6 and 12 months; To evaluate the rate of grade 4 (CTCAE, v. 4.0) hemorrhage, grade 4 febrile neutropenia, or any Grade 5 adverse event assessed to be definitely, probably, or possibly related to the induction or concurrent treatment components of the protocol regimen; To evaluate the rates of other adverse events (CTCAE, v. 4.0) assessed to be definitely, probably, or possibly related to the induction or concurrent treatment components of the protocol regimen; To evaluate the rate of treatment discontinuation due to toxicity during the induction or concurrent treatment components of the protocol regimen; To evaluate response (as per RECIST) of the primary site following the treatment component in subjects with measurable disease prior to chemoradiation.