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

Prostate Cancer Clinical Trial

Official title:

Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00348998
• Other study ID #: CDR0000480370
• Secondary ID: BRIVMRC-3031500G
• Status: Active, not recruiting
• Phase: Phase 2
• First received: July 5, 2006
• Last updated: November 5, 2013
• Start date: April 2006

Study information

• Verified date: November 2008
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 18
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Biological:
• bevacizumab

Drug:
• bicalutamide

• goserelin acetate

Radiation:
• radiation therapy

Locations

Country	Name	City	State
United States	Benaroya Research Institute at Virginia Mason Medical Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Mason Hospital/Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety			Yes
Primary	Efficacy			No