NCT01656304

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Barbara Ann Karmanos Cancer Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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.

Conditions

• Adenocarcinoma of the Prostate
• Recurrent Prostate Cancer
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer
• Stage III Prostate Cancer

Interventions

Type	Name	Description
BIOLOGICAL	bevacizumab	Given IV
OTHER	laboratory biomarker analysis	Correlative studies

Timeline

• Start date: 2007-05-01
• Primary completion: 2012-01-01
• Completion: 2012-06-01
• First posted: 2012-08-02
• Last updated: 2018-07-31
• Results posted: 2014-07-08

Locations

2 sites across 1 country: United States