Docetaxel, Bevacizumab and Androgen Deprivation Therapy After Definitive Local Therapy for Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Docetaxel; Bevacizumab; ADT; Bicalutamide
Intervention description: Intravenously given at 75 mg/m2 on day 1 of every 3 weeks for 4 cycles; Intravenously given at (15 mg/kg) on day 1 of every 3 weeks for 8 cycles; Either subcutaneously or intramuscularly every three months for a total of 6 doses (total of 18 months); Starting on day 84 orally once daily until hormone therapy is completed
Intervention MeSH terms: Bevacizumab; Docetaxel; Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 42.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Rising PSA; androgen deprivation; bevacizumab (avastin); docetaxel; lupron; zoladex; bicalutamide

Summary:

      In this research study, we aim to evaluate the feasibility, toxicity and efficacy of early
      multimodality systemic therapy (a combination of docetaxe, bevacizumab, and androgen
      deprivation therapy(ADT) in men with biochemical recurrence (BCR) or who have a rising
      Prostate Specific Antigen (PSA) after treatment of their prostate cancer with surgery or
      radiation)
    

Eligibility criteria:

        Inclusion Criteria:

          -  18 years of age or older

          -  History of biopsy documented prostate cancer (any Gleason score)

          -  Past treatment with prostatectomy with our without salvage prostate/pelvic radiation
             or primary radiation

          -  If past prostatectomy, pathologic stage no greater than T1-3, N1, M0

          -  PSA recurrence with PSAdt 8 months or less. There is no minimum PSA for prostatectomy
             patients. For patients treated with primary radiation therapy PSA should be 2.0ng/ml
             or greater

          -  No evidence of recurrent disease on exam, bone scan, CT/MRI abdomen/pelvis on CXR

          -  Prior ADT allowed if less than 6 months and testosterone recovered to within 50 units
             of normal range

          -  ECOG Performance status of 0-1

          -  Absolute neutrophil count of 1,500 mm3 or greater

          -  Platelet Count 100,000 mm3 or greater

          -  Total bilirubin within normal limits

          -  HG 8gm/dl or greater

          -  Testosterone within 50 units of normal range

          -  No history of bleeding or thromboses within the last 12 months that required medical
             intervention

        Exclusion Criteria:

          -  History of cancer within 5 years, other than prostate cancer and non-melanoma skin
             cancer

          -  Medical condition requiring concomitant corticosteroids

          -  Active infection

          -  Prior chemotherapy

          -  Neuropathy requiring medical therapy

          -  Documented local recurrence or metastatic prostate cancer

          -  Inability to comply with study and/or follow-up procedures

          -  Life expectancy of less than 2 years

          -  Current, recent (within 4 weeks of first infusion of this study), or planned
             participation in an experimental drug study other than a Genentech-sponsored Avastin
             cancer study

          -  Inadequately controlled hypertension

          -  Any prior history of hypertensive crisis or hypertensive encephalopathy

          -  NYHA Grade II or greater congestive heart failure

          -  History of myocardial infarction or unstable angina within 12 months prior to study
             enrollment

          -  History of stroke or transient ischemic attack at any time

          -  Known CNS disease

          -  Significant vascular disease

          -  Symptomatic peripheral vascular disease

          -  Evidence of bleeding diathesis or coagulopathy

          -  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 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

          -  Known hypersensitivity to any component of Avastin