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Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

Primary Purpose

Prostate Cancer

Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
bevacizumab
bicalutamide
goserelin acetate
radiation therapy
Sponsored by
Virginia Mason Hospital/Medical Center
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • Benaroya Research Institute at Virginia Mason Medical Center

Outcomes

Primary Outcome Measures

Safety
Efficacy

Secondary Outcome Measures

Full Information

First Posted
July 5, 2006
Last Updated
November 5, 2013
Sponsor
Virginia Mason Hospital/Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT00348998
Brief Title
Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer
Official Title
Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
November 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Virginia Mason Hospital/Medical Center

4. Oversight

5. Study Description

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 carry tumor-killing substances to them. Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin and bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to kill tumor cells. Bevacizumab may also make tumor cells more sensitive to radiation therapy. Giving bevacizumab together with hormone therapy and radiation therapy may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving bevacizumab together with hormone therapy and radiation therapy works in treating patients with high-risk locally advanced prostate cancer.
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 open-label, pilot study. Beginning in week 1, patients receive goserelin subcutaneously once every 3 months for 2 years. Patients also receive oral bicalutamide once daily and bevacizumab IV over 30- to 90-minutes once every 2 weeks in weeks 1-16 and undergo radiotherapy 5 days a week in weeks 9-16. After completion of radiotherapy, patients receive a higher dose of bevacizumab once every 3 weeks in weeks 17-28. After completion of study treatment, patients are evaluated at 30 days. PROJECTED ACCRUAL: A total of 18 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
adenocarcinoma of the prostate, stage IIB prostate cancer, stage IIA prostate cancer, stage III prostate cancer, stage IV prostate cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
None (Open Label)
Enrollment
18 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Biological
Intervention Name(s)
bevacizumab
Intervention Type
Drug
Intervention Name(s)
bicalutamide
Intervention Type
Drug
Intervention Name(s)
goserelin acetate
Intervention Type
Radiation
Intervention Name(s)
radiation therapy
Primary Outcome Measure Information:
Title
Safety
Title
Efficacy

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacqueline Vuky, MD
Organizational Affiliation
Virginia Mason Hospital/Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
Benaroya Research Institute at Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20818327
Citation
Karlou M, Tzelepi V, Efstathiou E. Therapeutic targeting of the prostate cancer microenvironment. Nat Rev Urol. 2010 Sep;7(9):494-509. doi: 10.1038/nrurol.2010.134.
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Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer

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