Status:
COMPLETED
Sunitinib Malate, Hormone Ablation and Radiation Therapy in Patients With Prostate Cancer
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
Pfizer
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE1
Brief 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 prost...
Detailed Description
The Study Drugs: Sunitinib malate is designed to block pathways that control important events such as the growth of blood vessels that are essential for the growth of cancer. Luteinizing Hormone-Rel...
Eligibility Criteria
Inclusion
- Adenocarcinoma of the prostate with the following high-risk features are eligible: clinical T2c, clinical or pathological T3 or T4 disease OR Gleason 8-10 disease OR PSA \> 20ng/ml.
- Patients must have no evidence of metastatic disease by clinical and radiological staging including Chest X-ray, Bone scan and CT Scan of the Abdomen and Pelvis.
- Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1
- Calculated Creatinine clearance \> 35cc/min, Absolute neutrophil count \> 1,500/mm\^3, Platelets \>/= 100,000/mm\^3, AST/ALT \< 2.5 x upper normal limit (UNL), Total bilirubin within normal limits (WNL).
- No standard contraindications to radiation therapy including prior radiation therapy, inflammatory bowel disease, irritable bowel syndrome, or and collagen vascular disease.
- Patients must be at least 18 years of age
- Patients may have had up to 8 weeks of hormonal therapy defined as luteinizing-hormone releasing hormone or other medical castration therapy prior to registration.
Exclusion
- Prior VEGFR/PDGFR inhibitor or other investigational therapy.
- Inability to take oral medication
- Chronically uncontrolled hypertension, defined conventionally as consistent/repeated systolic pressures above 140 mmHg or diastolic pressures above 90 mmHg despite anti-hypertensive therapy. This may be established with home BP readings. There is no criterion related to a specific BP result required for eligibility, nor are acute BP elevations that are related to iatrogenic causes, acute pain, or other transient reversible causes considered an exclusion criteria. The intent is to exclude patients with chronically uncontrolled hypertension that might be further exacerbated by Sunitinib.
- Left Ventricular Ejection Fraction \</= 40%, symptomatic congestive heart failure or symptomatic ischemic heart disease, deep venous thrombosis or pulmonary embolism in the last 12 months.
- Known human immunodeficiency virus infection, alcoholism, chronic active hepatitis or liver cirrhosis.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT00631527
Start Date
February 1 2008
Last Update
January 29 2015
Active Locations (1)
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1
University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030