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


Phase 2
18 Years
N/A
Open (Enrolling)
Male
Prostate Cancer

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Trial Information

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


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.

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

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Safety

Safety Issue:

Yes

Principal Investigator

Jacqueline Vuky, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Virginia Mason Hospital/Medical Center

Authority:

United States: Food and Drug Administration

Study ID:

CDR0000480370

NCT ID:

NCT00348998

Start Date:

April 2006

Completion Date:

Related Keywords:

  • Prostate Cancer
  • adenocarcinoma of the prostate
  • stage IIB prostate cancer
  • stage IIA prostate cancer
  • stage III prostate cancer
  • stage IV prostate cancer
  • Prostatic Neoplasms

Name

Location

Benaroya Research Institute at Virginia Mason Medical CenterSeattle, Washington  98101