Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy
|ClinicalTrials.gov Identifier: NCT01656304|
Recruitment Status : Completed
First Posted : August 2, 2012
Results First Posted : July 8, 2014
Last Update Posted : June 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer||Biological: bevacizumab Other: laboratory biomarker analysis||Phase 2|
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.
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.
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 (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Bevacizumab in PSA Relapse Androgen Independent Prostate Cancer (AVF3952sn)|
|Study Start Date :||May 2007|
|Actual Primary Completion Date :||January 2012|
|Actual Study Completion Date :||June 2012|
Experimental: Treatment (monoclonal antibody, antiangiogenesis)
Patients receive bevacizumab IV over 30-90 minutes once every 14 days. Courses repeat every 14 days in the absence of disease progression and unacceptable toxicity.
Other: laboratory biomarker analysis
- PSA Response Rate With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer [ Time Frame: An average every 6 weeks for up to 3 months ]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.
- Toxicities Associated With Bevacizumab Therapy [ Time Frame: An average of every 2 weeks while on 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 to PSA Progression (TTPP) [ Time Frame: An average every 6 weeks for up to 3 months ]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.
- Overall Survival of Androgen Independent Non-metastatic Prostate Cancer Patients Treated With Bevacizumab [ Time Frame: Every 3 months ]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).
- The Change in PSA Velocity With Bevacizumab Therapy in Androgen Independent Non-metastatic Prostate Cancer [ Time Frame: Baseline, every 6 weeks while on therapy, and then every 3 months thereafter ]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 to Distant Metastatic Disease [ Time Frame: Every 3 months ]Time to distant metastatic disease using the Kaplan-Meier method
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01656304
|United States, Michigan|
|Barbara Ann Karmanos Cancer Institute|
|Detroit, Michigan, United States, 48201|
|Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|Principal Investigator:||Ulka Vaishampayan||Barbara Ann Karmanos Cancer Institute|