Phase II Sunitinib Prog Met AIPC
Condition: Metastatic Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Sunitinib
Intervention description: 50 mg/day orally each of Days 1-28 of each 6 week cycle
Intervention MeSH terms: Sunitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 36.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      The purpose of this research study is to find out what effects (good and bad) Sutent has on
      you and your prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  A patient will be eligible for inclusion in this study if he meets all of the
             following criteria:

          -  Histologically confirmed, adenocarcinoma of the prostate

          -  Stage IV(metastatic) disease, documented on CT, MRI, or X-ray

          -  Progressive disease (PSA or clinical): PSA progression defined as baseline increase
             followed by any serial increase after 2 weeks; clinical progression by symptomatic or
             radiologic criteria.

          -  An elevated PSA level of for patients progressing by PSA criteria is required

          -  Currently on androgen ablation hormone therapy (an LHRH agonist or orchiectomy) with
             testosterone level <50ng/dL)

          -  Has received 1 or 2 prior chemotherapy regimens (no more than 2). One prior regimen
             must be docetaxel.

          -  Has an ECOG Performance Status (PS) 0-2

          -  Is greater than 18 years of age

          -  Meets protocol defined laboratory values

          -  Has adequate cardiac function in the opinion of the Investigator

          -  Has no uncontrolled arrhythmia or hypertension

          -  Resolution of all acute toxic effects of prior chemotherapy or surgical procedures to
             NCI CTCAE Version 3.0 Grade less than 1, in the opinion of the Treating Physician

          -  If fertile, patient has agreed to use an acceptable method of birth control to prevent
             pregnancy for the duration of the study and for a period of 2 months thereafter

          -  Has signed a Patient Informed Consent Form

          -  Has signed a Patient Authorization Form

        Exclusion Criteria:

          -  A patient will be excluded from this study if he meets any of the following criteria:

          -  Has any disease other than that described in inclusion criterion #1

          -  Had prior treatment with Sutent

          -  Has not received prior docetaxel for the current disease

          -  Has received any prior radionuclide therapy

          -  Has received prior radiation to >50% of the bone marrow

          -  Is receiving concurrent immunotherapy

          -  Has a history of hypersensitivity to any of the components of Sutent: mannitol,
             croscarmellose sodium, povidone (K-25) and magnesium stearate as inactive ingredients.
             The orange gelatin capsule shells contain titanium dioxide, and red iron oxide. The
             caramel gelatin capsule shells also contain yellow iron oxide and black iron oxide.
             The printing ink contains shellac, propylene glycol, sodium hydroxide, povidone and
             titanium dioxide.

          -  Has had significant bleeding in previous 4 weeks

          -  Has had any of the following within the prior 6 months: severe/unstable angina,
             myocardial infarction, coronary/peripheral artery bypass graft, congestive heart
             failure, cerebrovascular accident, transient ischemic attack, or pulmonary embolism

          -  Is receiving concurrent bisphosphonate therapy; long-standing bisphosphonate therapy
             (initiated >8 weeks prior to registration) is acceptable. Bisphosphonates started
             within the prior 8 weeks will not be allowed since this may affect other study
             endpoints and render their interpretation difficult

          -  Has received treatment with radiation therapy, surgery, chemotherapy, ketoconazole,
             corticosteroids, or an investigational agent within 4 weeks prior to registration, (6
             weeks for radiation therapy, nitrosureas or Mitomycin C)

          -  Has uncontrolled arrhythmia or hypertension

          -  Has evidence of uncontrolled CNS involvement (previous radiation and off steroids is
             acceptable)

          -  Pre-existing thyroid abnormality with thyroid function that cannot be maintained in
             the normal range with medication

          -  Has a serious uncontrolled intercurrent medical or psychiatric illness, including
             serious infection

          -  Has a history of other malignancy within the last 5 years (except cured basal cell
             carcinoma of skin), which could affect the diagnosis or assessment of any of the study
             drugs

          -  Is unable to comply with requirements of study