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Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

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ClinicalTrials.gov Identifier: NCT00349557
Recruitment Status : Completed
First Posted : July 7, 2006
Last Update Posted : July 16, 2014
Sponsor:
Collaborator:
Genentech, Inc.
Information provided by:
Benaroya Research Institute

Brief Summary:
The purpose of this study is to determine the acute and late toxicities from radiation therapy in combination with bevacizumab (given every 2 weeks for 16 weeks then every 3 weeks for 12 weeks), bicalutamide (every day for 16 weeks) and goserelin (every 3 months for 2 years).

Condition or disease Intervention/treatment Phase
Prostate Cancer Drug: bevacizumab, bicalutamide and goserelin Procedure: intensity modulated radiation therapy (IMRT) Phase 2

Detailed Description:

Although there is no data on the toxicity with concurrent bevacizumab and hormonal therapy, the combination is not expected to increase toxicity seen when given as a single agent. Abnormal tumor microenvironments, tumor progression, and metastatic spread are major factors contributing to treatment failures in radiotherapy. Anti-VEGF agents (e.g. bevacizumab) can help overcome these factors through several different mechanisims.

Studies also demonstrate prolonged use of anti-VEGF agents with radiation therapy was more effective at preventing metastases from irradiated tumors compared to a short course. Patients generally start hormonal therapy and daily radiotherapy at the same time. This study will delay the start of radiotherapy until 8 weeks after the start of hormonal therapy and bevacizumab.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer
Study Start Date : April 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources




Primary Outcome Measures :
  1. To determine the acute (within 90 days from 1st day of radiation therapy) toxicities from intensity modulated radiation therapy (IMRT) in conjunction with bevacizumab, bicalutamide, and goserelin.

Secondary Outcome Measures :
  1. To evaluate the late toxicities (>90 days from 1st day of radiation therapy) of IMRT, bevacizumab, bicalutamide, and goserelin. Patients will be followed on study for toxicity evaluation for at least one year from day 1 if radiation therapy.
  2. To determine the tolerability of the combination of bevacizumab and hormonal therapy.


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • High Risk Prostate Cancer as defined as ONE of the following:

    1. Clinical T2b-T4
    2. Gleason sum score 8-10
    3. PSA more than 20 and Gleason sum score 7
    4. In addition, clinical T2a patients are eligible if 5 or more biopsies contain Gleason 4+3 cancer (minimum of 10 biopsies total required)
  • No evidence of metastatic disease within 60 days of enrollment, confirmed by physical examination, chest x-ray, bone scan, and computed tomography of the abdomen and pelvis
  • ECOG performance status of 0, 1 or 2

Exclusion Criteria:

  • Concurrent or prior treatment with radiation, cytotoxic, biologic therapy for prostate cancer; any major surgery within four weeks, prior hormonal therapy (except finasteride for obstructive voiding symptoms)
  • Major surgical procedure, open biopsy, or significant traumatic injury within 28 days prior to Day 0, anticipation of need for major surgical procedure during the course of the study; Minor surgical procedures such as fine needle aspirations or core biopsies within 7 days prior to Day 0
  • Presence of central nervous system or brain metastases
  • Blood pressure of >150/100 mmHg
  • History of myocardial infarction within 6 months
  • History of stroke within 6 months
  • Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study other than a Genentech-sponsored bevacizumab cancer study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00349557


Locations
United States, Washington
Virginia Mason Medical Center
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Benaroya Research Institute
Genentech, Inc.
Investigators
Principal Investigator: Jacqueline Vuky, MD Virginia Mason Medical Center
Principal Investigator: Huong Pham, MD Virginia Mason Medical Center

ClinicalTrials.gov Identifier: NCT00349557     History of Changes
Other Study ID Numbers: BRI 3031500
First Posted: July 7, 2006    Key Record Dates
Last Update Posted: July 16, 2014
Last Verified: July 2014

Keywords provided by Benaroya Research Institute:
Prostate Cancer
High-Risk Prostate Cancer
1st line therapy

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bevacizumab
Bicalutamide
Goserelin
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Antineoplastic Agents
Antineoplastic Agents, Hormonal
Androgen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists