Status:
COMPLETED
Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer
Lead Sponsor:
Benaroya Research Institute
Collaborating Sponsors:
Genentech, Inc.
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bical...
Detailed Description
Although there is no data on the toxicity with concurrent bevacizumab and hormonal therapy, the combination is not expected to increase toxicity seen when given as a single agent. Abnormal tumor micro...
Eligibility Criteria
Inclusion
- High Risk Prostate Cancer as defined as ONE of the following:
- Clinical T2b-T4
- Gleason sum score 8-10
- PSA more than 20 and Gleason sum score 7
- In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required)
- No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
- ECOG performance status of 0, 1 or 2
Exclusion
- Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)
- Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
- Presence of central nervous system or brain metastases
- Blood pressure of \>150/100 mmHg
- History of myocardial infarction within 6 months
- History of stroke within 6 months
- Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study
Key Trial Info
Start Date :
April 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00349557
Start Date
April 1 2006
Last Update
July 16 2014
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Virginia Mason Medical Center
Seattle, Washington, United States, 98101