Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
The goal of this clinical research study is to learn the safety of adding 3 different dose-levels of Sutent® (sunitinib malate) to a combination of hormone therapy and radiation in patients with prostate cancer.
Drug: Sunitinib Malate
Radiation: Radiation Therapy (RT)
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Sunitinib, Hormonal Ablation and External Beam Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer|
- Maximum Tolerated Dose (MTD) as defined by Dose Limiting Toxicity (DLT) [ Time Frame: 8 weeks ] [ Designated as safety issue: Yes ]
DLT defined as inability to complete the schedule course of radiation therapy for toxicity of any grade. If < 2 patients in initial cohort of 6 experience DLT then a subsequent dose-level cohort initiated. If 2 or more patients in a cohort experience DLT then further accrual to that cohort curtailed and no higher dose level examined. Maximum tolerated dose (MTD) for oral sunitinib in combination with radiation and hormone ablation defined as highest dose level in which 6 patients have been treated with 2 or less than 2 instances of DLT.
DLT for the purposes of dose-escalation or calculation of the maximum tolerated dose (MTD) defined as any medically unmanageable Grade 2 toxicity or any Grade 3 or 4 toxicity experienced during the 8 week period of combined hormone ablation, Sunitinib, and radiation therapy.
|Study Start Date:||February 2008|
|Primary Completion Date:||January 2015 (Final data collection date for primary outcome measure)|
Experimental: Sunitinib Malate, Hormone Ablation + RT
Sunitinib Malate + Hormone Ablation (Leuprolide or Goserelin + Bicalutamide) + Radiation Therapy (RT)
Injections given through a needle in the muscle every 3 months.
Other Name: LupronDrug: Goserelin
Subcutaneous injections given once every 3 months.
Other Name: ZoladexDrug: Sunitinib Malate
Starting dose of 12.5 mg by mouth daily for 4 weeks
Other Names:Drug: Casodex
Once a day by mouth for 2 weeks.
Other Name: BicalutamideRadiation: Radiation Therapy (RT)
Radiation treatment once daily over a period of 8 weeks.
Other Name: Radiotherapy
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00631527
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Paul Corn, MD, PHD||M.D. Anderson Cancer Center|