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
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
16
Given IV
Correlative studies
Barbara Ann Karmanos Cancer Institute
Detroit, Michigan, United States
Henry Ford Hospital
Detroit, Michigan, United States
PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer
A PSA response will be considered a PSA decline of at least 50% must be confirmed by a second PSA value four or more weeks later. The reference PSA for these declines should be a PSA measured within 2 weeks prior to the initiation of therapy. Response rates will be summarized by point estimates and Wilson type 80% confidence intervals.
Time frame: An average every 6 weeks for up to 3 months
Toxicities Associated With Bevacizumab Therapy
Toxicity rates will be summarized by point estimates and Wilson type 90% confidence intervals. Toxicities will be graded per the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), and PSA response will be determined as per PSA Working Group response criteria. Censored time to PSA progression will be estimated with standard Kaplan-Meier methodology.
Time frame: An average of every 2 weeks while on therapy
Time to PSA Progression (TTPP)
TTPP will be measured from protocol registration to appearance of PSA progression as defined by the criteria of the PSA Working Group response criteria. The end point for progression will be calculated at the time a 25% increase in PSA has been achieved. PSA velocity will also be calculated as change in PSA doubling time pre and post therapy and the rate of PSA rise pre- and post-therapy.
Time frame: An average every 6 weeks for up to 3 months
Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab
Overall survival of androgen independent non-metastatic prostate cancer patients treated with bevacizumab. The number of patients still alive at the end of the study (median K-M estimate cannot be obtained due to the 86.7% censoring rate).
Time frame: Every 3 months
The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer
PSA velocity with bevacizumab therapy in androgen independent non-metastatic prostate cancer pre-therapy, as well as, PSA velocity with bevacizumab therapy while on therapy.
Time frame: Baseline, every 6 weeks while on therapy, and then every 3 months thereafter
Time to Distant Metastatic Disease
Time to distant metastatic disease using the Kaplan-Meier method
Time frame: Every 3 months
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