Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer - Full Text View

Sponsors and Collaborators:	Benaroya Research Institute Genentech
Information provided by:	Benaroya Research Institute
ClinicalTrials.gov Identifier:	NCT00349557

Purpose

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	Intervention	Phase
Prostate Cancer	Drug: bevacizumab, bicalutamide and goserelin Procedure: intensity modulated radiation therapy (IMRT)	Phase II

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Historical Control, Single Group Assignment, Safety/Efficacy Study
Official Title:	Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer

Resource links provided by NLM:

MedlinePlus related topics: Cancer Prostate Cancer Radiation Therapy

Drug Information available for: Goserelin Bicalutamide Bevacizumab

U.S. FDA Resources

Further study details as provided by Benaroya Research Institute:

Primary Outcome Measures:

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:

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.
To determine the tolerability of the combination of bevacizumab and hormonal therapy.

Estimated Enrollment:	18
Study Start Date:	April 2006

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00349557

Contacts

Contact: Sarah Warren, CRC	206-223-7507	sarah.warren@vmmc.org
Contact: Beth Edelheit, CRC	206-341-0446	beth.edelheit@vmmc.org

Locations

United States, Washington
Virginia Mason Medical Center	Recruiting
Seattle, Washington, United States, 98101
Contact: Sarah Warren, CRC 206-223-7507 sarah.warren@vmmc.org
Contact: Beth Edelheit, CRC 206-341-0446 beth.edelheit@vmmc.org

Sponsors and Collaborators

Benaroya Research Institute

Genentech

Investigators

Principal Investigator:	Jacqueline Vuky, MD	Virginia Mason Medical Center
Principal Investigator:	Huong Pham, MD	Virginia Mason Medical Center

More Information

Additional Information:

Search for active studies underway at the Benaroya Research Institute at Virginia Mason This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	BRI 3031500
Study First Received:	July 5, 2006
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00349557 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Benaroya Research Institute:

Prostate Cancer
High-Risk Prostate Cancer
1st line therapy

Study placed in the following topic categories:

Genital Neoplasms, Male
Prostatic Diseases
Hormone Antagonists
Goserelin
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bevacizumab

Genital Diseases, Male
Angiogenesis Inhibitors
Hormones
Androgen Antagonists
Bicalutamide
Prostatic Neoplasms
Androgens

Additional relevant MeSH terms:

Genital Neoplasms, Male
Prostatic Diseases
Antineoplastic Agents
Growth Substances
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Urogenital Neoplasms
Bevacizumab
Genital Diseases, Male

Angiogenesis Inhibitors
Pharmacologic Actions
Neoplasms
Androgen Antagonists
Neoplasms by Site
Therapeutic Uses
Bicalutamide
Growth Inhibitors
Angiogenesis Modulating Agents
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009