Bevacizumab With Hormonal and Radiotherapy for High-Risk Prostate Cancer

Prostate Cancer Clinical Trial

Official title:

Pilot Phase II Trial of Bevacizumab in Combination With Hormonal and Radiotherapy in Patients With High-Risk Prostate Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00349557
• Other study ID #: BRI 3031500
• Status: Completed
• Phase: Phase 2
• First received: July 5, 2006
• Last updated: July 15, 2014
• Start date: April 2006

Study information

• Verified date: July 2014
• Source: Benaroya Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Drug:
• bevacizumab, bicalutamide and goserelin

Procedure:
• intensity modulated radiation therapy (IMRT)

Locations

Country	Name	City	State
United States	Virginia Mason Medical Center	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Benaroya Research Institute	Genentech, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	To determine the tolerability of the combination of bevacizumab and hormonal therapy.