Phase II Trial of Avastin (Bevacizumab) in PSA Relapse Androgen Independent Prostate Cancer
OBJECTIVES:
Primary
- Determine the rate of prostate-specific antigen (PSA) response in patients with
relapsed androgen-independent prostate cancer treated with bevacizumab.
- Determine the toxicity of this drug in these patients.
- Determine the time to PSA progression in patients treated with this drug.
Secondary
- Determine the overall survival of patients treated with this drug.
- Determine the change in PSA velocity in patients treated with this drug.
- Determine the time to distant metastatic disease in patients treated with this drug.
- Determine the change in levels of N-terminal collagen peptide (NTX) and bone-specific
alkaline phosphatase (BSAP) in patients treated with this drug.
- Correlate urine NTX and serum BSAP levels with time to PSA progression in these
patients.
OUTLINE: This is a multicenter study.
Patients receive bevacizumab IV over 30-90 minutes on day 1. Treatment repeats every 14 days
in the absence of disease progression or unacceptable toxicity.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
Interventional
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Rate of prostate-specific antigen (PSA) response
at 12 weeks
No
Ulka N. Vaishampayan, MD
Study Chair
Barbara Ann Karmanos Cancer Institute
United States: Federal Government
CDR0000539272
NCT00478413
May 2007
June 2012
Name | Location |
---|---|
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Veterans Affairs Medical Center - Detroit | Detroit, Michigan 48201-1932 |
Josephine Ford Cancer Center at Henry Ford Hospital | Detroit, Michigan 48202 |