Treatment of Prostate Cancer With Adjuvant Bevacizumab Plus Erlotinib
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Erlotinib + Bevacizumab
Intervention description: Erlotinib every day for 24 weeks and Bevacizumab every 3 weeks for a total of 8 doses
Intervention MeSH terms: Bevacizumab; Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 23.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and effectiveness of bevacizumab plus
      erlotinib following radical prostatectomy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Karnofsky performance status of > 80

          -  Patients must have localized, organ-confined prostate cancer documented by physical
             examination, CT scan, or bone scan, and must have undergone radical prostatectomy.
             Post RP must have documented node negative prostate cancer.

          -  Pretreatment granulocyte count > 1500/mm3, hemoglobin > 9.0 g/dL, and platelet count >
             100,000/mm3,

          -  Normal PT and PTT

          -  Serum creatinine < 2.0 mg/dL

          -  Adequate hepatic function with a serum bilirubin < upper limit of normal (ULN), AST
             and ALT < 1.5x ULN, and alkaline phosphatase < 2.5x ULN.

          -  High-risk prostate cancer defined as a pre-RP prostate specific antigen level > 15
             ng/dL or a Gleason score of > 8 or Stage T3 disease or positive surgical margins

          -  Men of childbearing potential must be willing to consent to using effective
             contraception while on treatment and for 3 months thereafter

        Exclusion Criteria:

          -  Evidence of small cell (neuroendocrine) tumor

          -  Evidence of metastatic disease

          -  Prior administration of immunotherapy, biological therapy, hormonal therapy or
             radiation therapy for prostate cancer

          -  Active secondary malignancies (other than basal cell carcinoma of the skin)

          -  Serious, nonhealing wound, ulcer, or bone fracture.

          -  Clinically significant cardiovascular disease (e.g., blood pressure of >150/100 mmHg,
             myocardial infarction, or unstable angina), New York Heart Association (NYHA) Grade II
             or greater congestive heart failure, serious cardiac arrhythmia requiring medication,
             or clinically significant peripheral vascular disease. Patients with a history of
             myocardial infarction or stroke within the last 6 months will be excluded.

          -  Presence of seizures not controlled with standard medical therapy

          -  Active infection requiring parenteral antibiotics at the time of the first
             administration of study drugs

          -  Major surgical procedure, open biopsy, or significant traumatic injury within 28 days
             prior to Day 0, or anticipation of need for major surgical procedure during the course
             of the study; minor surgical procedures, fine needle aspirations or core biopsies
             within 7 days prior to Day 0.

          -  Current, recent (within the 4 weeks preceding Day 0), or planned participation in
             another experimental drug study

          -  Inability to comply with the study visit and follow-up schedule or procedures

          -  History of other disease, metabolic dysfunction, physical examination finding, or
             clinical laboratory finding giving reasonable suspicion of a disease or condition that
             contraindicates the use of an investigational drug or that might affect the
             interpretation of the results of the study or render the subject at high risk from
             treatment complications.

          -  Urine protein:creatinine ration > 1.0 at screening

          -  Evidence of bleeding diathesis or coagulopathy.

          -  History of abdominal fistula, gastrointestinal perforation, or intraabdominal abscess
             within 28 days prior to Day 0.

          -  Presence of central nervous system or brain metastases