INCLUSION CRITERIA
Androgen-independent metastatic adenocarcinoma of the prostate defined as progressive metastatic disease while on GnRH agonists or post surgical castration
Histopathological documentation of prostate cancer confirmed in the NCI Laboratory of Pathology at the National Institutes of Health, the Pathology Department at Walter Reed Medical Center or the Pathology Department at National Naval Medical Center, prior to starting this study. In addition, patients whose slides are lost or unavailable will be eligible for the study if they provide documentation of prostate cancer and if they meet criteria of clinically progressive prostate cancer as outlined in section 3.1.1.3.
Clinically progressive prostate cancer documented prior to entry. Progression must be documented by at least one of the following parameters:
-Two consecutively rising PSA levels. The first rising PSA must be a minimum of one week from a reference value. It is recognized that PSA fluctuations are such that the confirmatory PSA value might be less than the previous one. In these cases, that patient would still be eligible provided the next PSA was greater than the first rising PSA value. Patients must have PSA greater than or equal to 5.0.
-At least one new lesion on bone scan.
-Progressive measurable disease.
Patients must have undergone bilateral surgical castration or must continue on GNRH agonist.
Those patients receiving an anti-androgen agent and are entering the trial due to a rise in PSA must demonstrate a continued rise in PSA 4 weeks after stopping flutamide and 6 weeks after stopping bicalutamide or nilutamide.
Patients may not have received any chemotherapy for metastatic prostate cancer
Age greater than or equal to 18 years
ECOG performance status less than or equal to 2
Life expectancy of greater than 3 months
Patients must have adequate organ and marrow munction as defined below:
Leukocytes- greater than or equal to 3,000/microliter
Absolute neutrophil count- greater than or equal to 1,500/microliter
Platelets- greater than or equal to 100,000/microliter
Hemoglobin- greater than or equal to 8.0g/L - transfusions acceptable
Total bilirubin- less than or equal to 1.5 times the institutional upper limits of normal
AST(SGOT) and ALT(SGPT) - less than or equal to 2.5 times the institutional upper limits of normal
Creatinine or Creatinine clearance- less than or equal to 1.5 times the institutional upper limits of normal or greater than or equal to 40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal.
Recovered from any toxicity from surgery or radiotherapy
Must be willing to travel from their home to the NIH for follow-up visits
Able and willing to follow instructions and conform to protocol.
Patients may have had no other active malignancy within the past 2 years with the exception of non-melanoma skin cancer and superficial bladder carcinoma
No history of myocardial infarction within the past 6 months, uncontrolled CHF or uncontrolled angina pectoris
Patients must agree to use adequate contraception (abstinence; hormonal or barrier method of birth control) for the study and at least 2 months after completion.
Ability to understand and the willingness to sign a written informed consent document.
EXCLUSION CRITERIA
Present clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT or MRI brain scan.
Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure (AHA Class II or worse), unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
Persistent systolic blood pressure greater than or equal to 170 mmHg or diastolic blood pressure greater than or equal to 100 mmHg.
HIV-positive patients receiving combination anti-retroviral therapy are excluded fron the study because of possible pharmacokinetic interactions with docetaxel, bevacizumab, and/or the combination.
Proteinuria, defined as a 24 hour urine protein excretion greater than 300 mg, required to be measured if urine dipstick is 1 +.
Therapeutic anticoagulation with coumadin, heparins, or heparinoids.
Greater than Grade 2 peripheral neuropathy at baseline.
History of transient ischemic attacks (TIA) or cerebrovascular accident (CVA) within the past 2 years.
History of allergic reaction to docetaxel, prednisone, thalidomide and/or bevacizumab or related products.
Patients who are on concurrent investigational agent(s)
Patients who are unable to ingest oral medication.
INCLUSION OF WOMEN AND MINORITIES
Men of all races and ethnic groups are eligible for this trial. Every effort will be made to recruit minorities in this study. Women are ineligible for this study.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/31/2009