Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

NCT ID: NCT00349557

Last Updated: 2014-07-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-04-30

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).

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

bevacizumab, bicalutamide and goserelin

Intervention Type: DRUG

intensity modulated radiation therapy (IMRT)

Intervention Type: PROCEDURE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Genentech, Inc.

INDUSTRY

Sponsor Role: collaborator

Benaroya Research Institute

OTHER

Sponsor Role: lead

Principal Investigators

Jacqueline Vuky, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Huong Pham, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Mason Medical Center

Locations

Virginia Mason Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

BRI 3031500

Identifier Type: -

Identifier Source: org_study_id