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| ID | Type | Description | Link |
|---|---|---|---|
| BRIVMRC-3031500 | |||
| GENENTECH-AVF3549s |
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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.
OBJECTIVES:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| bevacizumab | Biological | |||
| bicalutamide | Drug | |||
| goserelin acetate | Drug | |||
| radiation therapy | Radiation |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | ||
| Efficacy |
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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
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:
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| Jacqueline Vuky, MD | Virginia Mason Hospital/Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Benaroya Research Institute at Virginia Mason Medical Center | Seattle | Washington | 98101 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20818327 | Background | 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. |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D000068258 | Bevacizumab |
| C053541 | bicalutamide |
| D017273 | Goserelin |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D007987 | Gonadotropin-Releasing Hormone |
| D010906 | Pituitary Hormone-Releasing Hormones |
| D007028 | Hypothalamic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D009479 | Neuropeptides |
| D010455 | Peptides |
| D009842 | Oligopeptides |
| D009419 | Nerve Tissue Proteins |
| D013812 | Therapeutics |