Bevacizumab in Treating Patients With Relapsed Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Adenocarcinoma of the Prostate; Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: bevacizumab; laboratory biomarker analysis
Intervention description: Given IV; Correlative studies
Intervention MeSH terms: Bevacizumab; Antineoplastic Agents, Immunological; Antibodies; Immunoglobulins; Antibodies, Monoclonal
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      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
    

Eligibility criteria:

        Inclusion Criteria:

          -  A histologic diagnosis of prostate adenocarcinoma.

          -  No evidence of bone/visceral metastases as visualized on standard imaging such as bone
             scan, chest X-ray, CT scan or MRI of abdomen and pelvis.

          -  PSA-only progression despite androgen deprivation therapy. PSA progression is defined
             as 3 rising levels, with a minimum interval of 2 weeks between each determination. The
             last determination must have a minimum value of

             1ng/ml and be determined within two weeks prior to registration. If the second or
             third confirmatory value is less than the previous value, the patient will still be
             eligible if a repeat value (No. 4) is found to be greater than all the prior values.

          -  If patient has been on antiandrogen in the past 28 days, then PSA progression after
             withdrawal period (28 days for flutamide and 42 days for bicalutamide or nilutamide)
             is required.

          -  ECOG performance status of 0-1.

          -  No prior avastin therapy.

          -  No investigational or commercial agents or therapies (except LHRH agonists) may be
             administered concurrently with the intent to treat the patient's malignancy. Patients
             on LHRH agonists must continue the use of LHRH agonist therapy. Bisphosphonates can be
             administered per treating physician discretion.

          -  At least 4 weeks must have elapsed since prior systemic therapy, except for LHRH
             analogue therapy and steroids. If steroids are being used for therapy of prostate
             cancer, these should be discontinued prior to starting avastin therapy.

          -  Age ≥ 18 years.

          -  Life expectancy of at least 6 months.

          -  Ability to understand and the willingness to sign a written informed consent that is
             approved by the Institutional Human Investigation Committee.

          -  Use of effective means of contraception in subjects.

        Exclusion Criteria:

        Inability to comply with study and/or follow-up procedures.

          -  Inadequately controlled hypertension (defined as systolic blood pressure >150 and/or
             diastolic blood pressure > 100 mmHg on antihypertensive medications).

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy.

          -  New York Heart Association (NYHA) Grade II or greater congestive heart failure (see
             Appendix E).

          -  History of myocardial infarction or unstable angina within last 12 months prior to
             study enrollment.

          -  History of stroke or transient ischemic attack within 6 months prior to study
             enrollment.

          -  Known CNS disease.

          -  Significant vascular disease (e.g., aortic aneurysm, aortic dissection).

          -  Symptomatic peripheral vascular disease.

          -  Evidence of bleeding diathesis or coagulopathy.

          -  Patients on anticoagulants are allowed if patient has been on therapy for at least 4
             weeks and patient has no acute thromboembolic activity.

          -  Major surgical procedure, open biopsy, or significant traumatic injury within. 28 days
             prior to study enrollment or anticipation of need for major surgical procedure during
             the course of the study.

          -  Core biopsy or other minor surgical procedure, excluding placement of a vascular
             access device, within 7 days prior to study enrollment.

          -  History of abdominal fistula, gastrointestinal perforation, or intra-abdominal abscess
             within 6 months prior to study enrollment.

          -  Serious, non-healing wound, ulcer, or bone fracture.

          -  Proteinuria at screening as demonstrated by:

             1. Urine protein:creatinine (UPC) ratio ≥ 1.0 at screening

          -  Known hypersensitivity to any component of avastin.

          -  Refusal to use effective means of contraception.

          -  Patients with known brain metastases should be excluded from this clinical trial
             because of their poor prognosis and because they often develop progressive neurologic
             dysfunction that would confound the evaluation of neurologic and other adverse events.

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to avastin.

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements.

          -  Patients with immune deficiency such as HIV-positive patients or those receiving
             combination anti-retroviral therapy are excluded from the study because of lack of
             safety data for avastin in these patients.