Status:
UNKNOWN
Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
Lead Sponsor:
Virginia Mason Hospital/Medical Center
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or...
Detailed Description
OBJECTIVES: * Determine the safety and efficacy of giving bevacizumab together with hormonal therapy and radiotherapy in patients with high-risk locally advanced prostate cancer. OUTLINE: This is an...
Eligibility Criteria
Inclusion
- DISEASE CHARACTERISTICS:
- Histologically confirmed adenocarcinoma of the prostate
- High-risk, locally advanced disease (T2b-T4 disease), meeting 1 of the following criteria:
- Gleason score 8-10
- Prostate-specific antigen \> 20 ng/dL AND Gleason score 7
- T2a disease allowed provided ≥ 5 biopsies contain Gleason score 4 +3 cancer (minimum of 10 biopsies total required)
- No evidence of metastatic disease within the past 60 days by physical examination, chest x-ray, bone scan, and CT scan of abdomen and pelvis
- PATIENT CHARACTERISTICS:
- ECOG performance status 0-2
- Hemoglobin \> 8 g/dL
- Absolute granulocyte count ≥ 1,500/mm³
- Platelet count ≥ 100,000/mm³
- Bilirubin ≤ 1.5 times upper limit of normal (ULN)
- Creatinine ≤ 1.5 times ULN
- Blood pressure ≤ 150/100 mm Hg
- No cardiovascular disease, including any of the following:
- Unstable angina
- New York Heart Association class II-IV congestive heart failure
- History of myocardial infarction within the past 6 months
- History of stroke within the past 6 months
- PRIOR CONCURRENT THERAPY:
- At least 4 weeks since prior major surgery
- No prior hormonal therapy (except finasteride for obstructive voiding symptoms) for prostate cancer
- No prior or concurrent chemotherapy, biologic therapy, or radiotherapy for prostate cancer
Exclusion
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00348998
Start Date
April 1 2006
Last Update
November 6 2013
Active Locations (1)
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1
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98101