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Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy
This study is currently recruiting participants.
Verified by National Cancer Institute (NCI), December 2008
Sponsors and Collaborators: Barbara Ann Karmanos Cancer Institute
National Cancer Institute (NCI)
Information provided by: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT00478413
  Purpose

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
Prostate Cancer
Drug: bevacizumab
Phase II

MedlinePlus related topics: Cancer Prostate Cancer
Drug Information available for: Bevacizumab
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Open Label
Official Title: Phase II Trial of Avastin (Bevacizumab) in PSA Relapse Androgen Independent Prostate Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Rate of prostate-specific antigen (PSA) response [ Designated as safety issue: No ]
  • Toxicity [ Designated as safety issue: Yes ]
  • Time to PSA progression [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Change in PSA velocity [ Designated as safety issue: No ]
  • Time to distant metastatic disease [ Designated as safety issue: No ]
  • Change in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) [ Designated as safety issue: No ]
  • Correlation of urine NTX and serum BSAP levels with time to PSA progression [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2007
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Histologically confirmed adenocarcinoma of the prostate
  • 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

    • Patients with a second or third confirmatory PSA value less than the previous value are eligible provided a fourth PSA value is greater than all prior values
    • A withdrawl period (4 weeks for flutamide and 6 weeks for bicalutamide or nilutamide) is required to document PSA progression for patients who have been on antiandrogen therapy within the past 4 weeks
  • No known CNS disease
  • No evidence of metastatic disease by standard imaging (i.e., bone scan, chest x-ray or chest CT scan, and CT scan or MRI of the abdomen and pelvis)
  • No known brain metastases

PATIENT CHARACTERISTICS:

  • ECOG performance status 0-1
  • Life expectancy ≥ 6 months
  • Fertile patients must use effective contraception
  • No proteinuria, defined by 1 of the following:

    • Urine protein:creatinine ratio < 1.0
    • Proteinuria < 2+ by dipstick urinalysis
    • Proteinuria ≤ 1 g by 24-hour urine collection (for patients with proteinuria ≥ 2+ by dipstick urinalysis)
  • No other uncontrolled illness, including, but not limited to, any of the following:

    • Ongoing or active infection
    • Symptomatic congestive heart failure
    • Unstable angina pectoris
    • Cardiac arrhythmia
    • Psychiatric or social situation that would preclude study compliance
  • No uncontrolled hypertension, defined as systolic blood pressure (BP) > 150 mm Hg and/or diastolic BP > 100 mm Hg on antihypertensive medication
  • No history of hypertensive crisis or hypertensive encephalopathy
  • No New York Heart Association class II-IV congestive heart failure
  • No myocardial infarction or unstable angina within the past 12 months
  • No stroke or transient ischemic attack within the past 6 months
  • No abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess within the past 6 months
  • No significant traumatic injury within the past 28 days
  • No significant vascular disease (i.e., aortic aneurysm or aortic dissection)
  • No symptomatic peripheral vascular disease
  • No evidence of bleeding diathesis or coagulopathy
  • No serious nonhealing wound, ulcer, or bone fracture
  • No hypersensitivity to any component of bevacizumab
  • No history of allergic reactions attributed to compounds of similar chemical or biological composition to bevacizumab

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  • At least 1 week since prior core biopsy or other minor surgical procedure (excluding placement of a vascular access device)
  • At least 4 weeks since prior major surgical procedure or open biopsy
  • At least 4 weeks since prior systemic therapy except for luteinizing hormone-releasing hormone (LHRH) analogue therapy or steroids

    • Patients receiving LHRH agonist therapy must continue LHRH agonist therapy during study participation
    • Steroids used for treatment of prostate cancer should be discontinued prior to starting bevacizumab
  • No prior bevacizumab
  • No concurrent major surgical procedure
  • No concurrent antiretroviral therapy for patients with immune deficiencies, such as HIV
  • No other concurrent investigational or commercial agents or therapies (except LHRH agonists) for this malignancy
  • Concurrent anticoagulants allowed provided patient has been on therapy for at least 4 weeks and has no acute thromboembolic activity
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00478413

Locations
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        
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
  More Information

Clinical trial summary from the National Cancer Institute's PDQ® database  This link exits the ClinicalTrials.gov site

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

Keywords provided by National Cancer Institute (NCI):
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
recurrent prostate cancer
stage IV prostate cancer

Study placed in the following topic categories:
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Bevacizumab
Genital Diseases, Male
Adenocarcinoma
Prostatic Neoplasms
Recurrence

Additional relevant MeSH terms:
Neoplasms
Neoplasms by Site
Antineoplastic Agents
Therapeutic Uses
Growth Substances
Physiological Effects of Drugs
Growth Inhibitors
Angiogenesis Modulating Agents
Angiogenesis Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009