Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer
Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer
1 other identifier
interventional
18
1 country
1
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), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2 prostate-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2006
CompletedFirst Submitted
Initial submission to the registry
July 5, 2006
CompletedFirst Posted
Study publicly available on registry
July 7, 2006
CompletedJuly 16, 2014
July 1, 2014
July 5, 2006
July 15, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To determine the acute (within 90 days from 1st day of radiation therapy) toxicities from intensity modulated radiation therapy (IMRT) in conjunction with bevacizumab, bicalutamide, and goserelin.
Secondary Outcomes (2)
To evaluate the late toxicities (>90 days from 1st day of radiation therapy) of IMRT, bevacizumab, bicalutamide, and goserelin. Patients will be followed on study for toxicity evaluation for at least one year from day 1 if radiation therapy.
To determine the tolerability of the combination of bevacizumab and hormonal therapy.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Benaroya Research Institutelead
- Genentech, Inc.collaborator
Study Sites (1)
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jacqueline Vuky, MD
Virginia Mason Medical Center
- PRINCIPAL INVESTIGATOR
Huong Pham, MD
Virginia Mason Medical Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 5, 2006
First Posted
July 7, 2006
Study Start
April 1, 2006
Last Updated
July 16, 2014
Record last verified: 2014-07