Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatments bevacizumab, bicalutamide, goserelin acetate, radiation therapy
Phase phase 2
Target VEGF
Sponsor Virginia Mason Hospital/Medical Center
Start date April 2006
Trial size 18 participants
Trial identifier NCT00348998, BRIVMRC-3031500, CDR0000480370, GENENTECH-AVF3549s

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Safety
time frame:
Efficacy
time frame:

Eligibility Criteria

Male participants at least 18 years old.

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

Additional Information

Official title Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2013.
Information provided to ClinicalTrials.gov by National Cancer Institute (NCI).