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Sponsors and Collaborators: |
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00478413 |
RATIONALE: 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 carry tumor-killing substances to them. Bevacizumab may also stop the growth of prostate cancer by blocking blood flow to the tumor.
PURPOSE: This phase II trial is studying the side effects and how well bevacizumab works in treating patients with relapsed prostate cancer that did not respond to hormone therapy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: bevacizumab |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | Phase II Trial of Avastin (Bevacizumab) in PSA Relapse Androgen Independent Prostate Cancer |
Estimated Enrollment: | 30 |
Study Start Date: | May 2007 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
OBJECTIVES:
Primary
Secondary
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Prostate-specific antigen (PSA)-only progression despite androgen deprivation therapy, defined as 3 rising PSA levels with an interval of ≥ 2 weeks between each determination AND the most recent PSA level ≥ 1 ng/mL within the past 2 weeks
PATIENT CHARACTERISTICS:
No proteinuria, defined by 1 of the following:
No other uncontrolled illness, including, but not limited to, any of the following:
PRIOR CONCURRENT THERAPY:
At least 4 weeks since prior systemic therapy except for luteinizing hormone-releasing hormone (LHRH) analogue therapy or steroids
United States, Michigan | |
Barbara Ann Karmanos Cancer Institute | Recruiting |
Detroit, Michigan, United States, 48201-1379 | |
Contact: Clinical Trials Office - Barbara Ann Karmanos Cancer Institute 313-576-9363 | |
Josephine Ford Cancer Center at Henry Ford Hospital | Recruiting |
Detroit, Michigan, United States, 48202 | |
Contact: Contact Person 313-916-1850 | |
Sinai-Grace Hospital | Recruiting |
Detroit, Michigan, United States, 48235 | |
Contact: Ulka N. Vaishampayan 313-576-8718 | |
Veterans Affairs Medical Center - Detroit | Recruiting |
Detroit, Michigan, United States, 48201 | |
Contact: Contact Person 313-576-1000 |
Study Chair: | Ulka N. Vaishampayan, MD | Barbara Ann Karmanos Cancer Institute |
Responsible Party: | Barbara Ann Karmanos Cancer Institute ( Ulka N. Vaishampayan ) |
Study ID Numbers: | CDR0000539272, WSU-2006-064, WSU-HIC-035307MP4F, GENENTECH-0703004652 |
Study First Received: | May 23, 2007 |
Last Updated: | December 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00478413 |
Health Authority: | Unspecified |
adenocarcinoma of the prostate stage I prostate cancer stage II prostate cancer |
stage III prostate cancer recurrent prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Bevacizumab |
Genital Diseases, Male Adenocarcinoma Prostatic Neoplasms Recurrence |
Neoplasms Neoplasms by Site Antineoplastic Agents Therapeutic Uses Growth Substances |
Physiological Effects of Drugs Growth Inhibitors Angiogenesis Modulating Agents Angiogenesis Inhibitors Pharmacologic Actions |