Bevacizumab, Hormone Therapy, and Radiation Therapy in Treating Patients With Locally Advanced Prostate Cancer - Full Text View

Sponsored by:	Virginia Mason Hospital/Medical Center
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00348998

Purpose

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.

Condition	Intervention	Phase
Prostate Cancer	Drug: bevacizumab Drug: bicalutamide Drug: goserelin Procedure: radiation therapy	Phase II

MedlinePlus related topics: Cancer Prostate Cancer

Drug Information available for: Bevacizumab Goserelin Bicalutamide

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Safety [ Designated as safety issue: Yes ]
Efficacy [ Designated as safety issue: No ]

Estimated Enrollment:	18
Study Start Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00348998

Locations

United States, Washington
Benaroya Research Institute at Virginia Mason Medical Center
Seattle, Washington, United States, 98101

Sponsors and Collaborators

Virginia Mason Hospital/Medical Center

Investigators

Study Chair:

Jacqueline Vuky, MD

Virginia Mason Hospital/Medical Center

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Study ID Numbers:	CDR0000480370, BRIVMRC-3031500, GENENTECH-AVF3549s
Study First Received:	July 5, 2006
Last Updated:	December 3, 2008
ClinicalTrials.gov Identifier:	NCT00348998
Health Authority:	United States: Food and Drug Administration

Keywords provided by National Cancer Institute (NCI):

adenocarcinoma of the prostate
stage II prostate cancer
stage III prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:

Prostatic Diseases
Genital Neoplasms, Male
Goserelin
Bicalutamide
Urogenital Neoplasms

Bevacizumab
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms

Additional relevant MeSH terms:

Antineoplastic Agents
Hormone Antagonists
Growth Substances
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Angiogenesis Inhibitors
Pharmacologic Actions

Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Angiogenesis Modulating Agents
Growth Inhibitors

ClinicalTrials.gov processed this record on January 14, 2009