Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
NCT00631527 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19
Last updated 2015-01-29
Summary
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.
Conditions
Interventions
- DRUG
-
Leuprolide
Injections given through a needle in the muscle every 3 months.
- DRUG
-
Goserelin
Subcutaneous injections given once every 3 months.
- DRUG
-
Sunitinib Malate
Starting dose of 12.5 mg by mouth daily for 4 weeks
- DRUG
-
Casodex
Once a day by mouth for 2 weeks.
- RADIATION
-
Radiation Therapy (RT)
Radiation treatment once daily over a period of 8 weeks.
Sponsors & Collaborators
- collaborator INDUSTRY
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Paul Corn, MD, PHD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- MALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-02-29
- Primary Completion
- 2015-01-31
Countries
- United States
Study Locations
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