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

NCT ID: NCT00348998

Last Updated: 2013-11-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30

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.

Conditions

Prostate Cancer

Keywords

adenocarcinoma of the prostate; stage IIB prostate cancer; stage IIA prostate cancer; stage III prostate cancer; stage IV prostate cancer

Study Design

• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bevacizumab

Intervention Type: BIOLOGICAL

bicalutamide

Intervention Type: DRUG

goserelin acetate

Intervention Type: DRUG

radiation therapy

Intervention Type: RADIATION

Eligibility Criteria

Inclusion 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Virginia Mason Hospital/Medical Center

OTHER

Sponsor Role: lead

Principal Investigators

Jacqueline Vuky, MD

Role: STUDY_CHAIR

Virginia Mason Hospital/Medical Center

Locations

Benaroya Research Institute at Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 20818327 (View on PubMed)

Other Identifiers

BRIVMRC-3031500

Identifier Type: -

Identifier Source: secondary_id

GENENTECH-AVF3549s

Identifier Type: -

Identifier Source: secondary_id

CDR0000480370

Identifier Type: -

Identifier Source: org_study_id