Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier:
NCT00478413
First received: May 23, 2007
Last updated: August 9, 2012
Last verified: August 2012
  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
Biological: bevacizumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Avastin (Bevacizumab) in PSA Relapse Androgen Independent Prostate Cancer

Resource links provided by NLM:


Further study details as provided by Barbara Ann Karmanos Cancer Institute:

Primary Outcome Measures:
  • Rate of prostate-specific antigen (PSA) response [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]
  • Toxicity [ Time Frame: at 12 weeks ] [ Designated as safety issue: Yes ]
  • Time to PSA progression [ Time Frame: at 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: followed until death ] [ Designated as safety issue: No ]
  • Change in PSA velocity [ Time Frame: Repeated every 6 weeks while on therapy: prestudy, week 7, week 13, etc. After discontinuing protocol therapy PSA to be performed at a minimum of every 3 months ] [ Designated as safety issue: No ]
  • Time to distant metastatic disease [ Time Frame: Every 3 months during therapy, thereafter at the physician's discreation ] [ Designated as safety issue: No ]
  • Change in levels of N-terminal collagen peptide (NTX) and bone-specific alkaline phosphatase (BSAP) [ Time Frame: Pre-study, weeks 7 and 12 ] [ Designated as safety issue: No ]
  • Correlation of urine NTX and serum BSAP levels with time to PSA progression [ Time Frame: Pre-study, weeks 7 and 12 ] [ Designated as safety issue: No ]

Enrollment: 16
Study Start Date: May 2007
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Bevacizumab
Bevacizumab treatment will be administered on an outpatient basis at a dose of 10mg/kg intravenously every 14 days. The initial avastin dose is to be administered over a minimum of 90 minutes. If no adverse reactions occur, the second dose is to be administered over a minimum of 60 minutes. Again, if no adverse reactions occur, the third and subsequent doses are to be administered over a minimum of 30 minutes. Premedications can be used at the treating physician's discretion. Steroid premedications should be avoided if possible
Biological: bevacizumab
IV
Other Name: Avastin ®

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
Detroit, Michigan, United States, 48201-1379
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, United States, 48202
Veterans Affairs Medical Center - Detroit
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
Barbara Ann Karmanos Cancer Institute
Investigators
Study Chair: Ulka N. Vaishampayan, MD Barbara Ann Karmanos Cancer Institute
  More Information

Additional Information:
No publications provided

Responsible Party: Ulka N. Vaishampayan, Barbara Ann Karmanos Cancer Institute
ClinicalTrials.gov Identifier: NCT00478413     History of Changes
Other Study ID Numbers: CDR0000539272, P30CA022453, WSU-2006-064, WSU-HIC-035307MP4F, GENENTECH-0703004652
Study First Received: May 23, 2007
Last Updated: August 9, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

Keywords provided by Barbara Ann Karmanos Cancer Institute:
adenocarcinoma of the prostate
stage I prostate cancer
stage II prostate cancer
stage III prostate cancer
recurrent prostate cancer
stage IV prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013