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

NCT00348998 | Unknown Phase 2

• 3 other identifiers: CDR0000480370BRIVMRC-3031500GENENTECH-AVF3549s
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Safety

• Efficacy

Interventions

bevacizumab BIOLOGICAL

bicalutamide DRUG

goserelin acetate DRUG

radiation therapy RADIATION

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Virginia Mason Hospital/Medical Center: lead

Study Sites (1)

Benaroya Research Institute at Virginia Mason Medical Center

Seattle, Washington, 98101, United States

Location

Related 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.

  PMID: 20818327 BACKGROUND

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Bevacizumab; bicalutamide; Goserelin; Radiotherapy

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Oligopeptides; Nerve Tissue Proteins; Therapeutics

Study Officials

• Jacqueline Vuky, MD

  Virginia Mason Hospital/Medical Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 5, 2006
• First Posted: July 6, 2006
• Study Start: April 1, 2006
• Last Updated: November 6, 2013

Record last verified: 2008-11

Locations

US (1)