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Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy

Adenocarcinoma of the Prostate Clinical Trial

Official title:
Phase II Trial of Bevacizumab in PSA Relapse Androgen Independent Prostate Cancer (AVF3952sn)

Clinical Trial Summary

This pilot phase II trial studies how well giving bevacizumab works in treating patients with relapsed prostate cancer that did not respond to hormone therapy. 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 tumor-killing substances to them. Bevacizumab may also stop the growth of prostate cancer by blocking blood flow to the tumor

Clinical Trial Description

PRIMARY OBJECTIVES:

I. The rate of prostate-specific antigen (PSA) response with avastin (bevacizumab) therapy in androgen independent non-metastatic prostate cancer.

II. Toxicities associated with avastin therapy. III. Time to PSA progression.

SECONDARY OBJECTIVES:

I. Overall survival of androgen independent non-metastatic prostate cancer patients treated with avastin.

II. The change in PSA velocity with avastin therapy in androgen-independent non-metastatic prostate cancer.

III. Time to distant metastatic disease. IV. Circulating tumor cell count. V. Changes in levels of N terminal collagen peptide and bone-specific alkaline phosphatase with avastin therapy.

VI. Correlation of crosslinked N-telopeptide of type I collagen (NTX) and serum B-Cell-Specific Activator Protein (BSAP) levels with time to PSA progression.

OUTLINE:

Patients receive bevacizumab intravenously (IV) over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01656304
Study type Interventional
Source Barbara Ann Karmanos Cancer Institute
Contact
Status Completed
Phase Phase 2
Start date May 2007
Completion date June 2012
View Details
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