AZD0530 in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: saracatinib; laboratory biomarker analysis
Intervention description: Given orally; Correlative studies
Intervention MeSH terms: Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial is studying how well AZD0530 works in treating patients with prostate
      cancer that did not respond to hormone therapy. AZD0530 may stop the growth of tumor cells by
      blocking some of the enzymes needed for cell growth
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically or cytologically confirmed prostate cancer with a Gleason score
             available or interpretable and meeting 1 of the following criteria:

               -  No prior chemotherapy and relatively minimal cancer spread

               -  Only one prior taxane-based chemotherapy for aggressive and/or symptomatic
                  disease

          -  Must have prostate cancer considered to be hormone refractory or androgen independent
             by one or more of the following criteria (despite androgen deprivation and
             anti-androgen withdrawal when applicable):

               -  Progression of unidimensionally measurable disease assessed within 28 days prior
                  to initial administration of drug

               -  Progression of evaluable but not measurable disease assessed within 28 days prior
                  to initial administration of drug for PSA evaluation and within 42 days for
                  imaging studies (e.g., bone scans)

          -  Patients must have nonmeasurable disease (e.g., nuclear medicine bone scans) and
             non-target lesions (e.g., PSA level) assessed within 28 days prior to initial
             administration of drug

               -  Measurable disease is not required but is allowed

          -  Must be surgically or medically castrated

               -  If the method of castration was luteinizing hormone-releasing hormone (LHRH)
                  agonists (e.g., leuprolide or goserelin), then the patient must be willing to
                  continue the use of LHRH agonists

               -  Serum testosterone must be at castrate levels (< 50 ng/dL) at least 3 months
                  prior to registration

          -  ECOG performance status 0-2

          -  WBC >= 3,000/uL

          -  Absolute neutrophil count >= 1,500/uL

          -  Platelets >= 100,000/uL

          -  Hemoglobin > 9 g/d

          -  Total bilirubin within normal institutional limits

          -  AST/ALT =< 2.5 x institutional upper limit of normal

          -  Creatinine within normal institutional limits OR creatinine clearance >= 60 mL/min

          -  Must agree to use adequate contraception prior to study entry and for the duration of
             study participation

          -  At least 3 weeks since the completion of chemotherapy and radiotherapy and the patient
             must have recovered from the side effects of the therapy

          -  At least 28 days since prior non-steroidal anti-androgens (e.g., flutamide) (42 days
             for bicalutamide or nilutamide) or hormonal treatment (e.g., ketoconazole) and
             demonstrated progression of disease since the agents were suspended

          -  Concurrent bisphosphonate therapy is allowed

        Exclusion Criteria:

          -  Known brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or
             biological composition to AZD0530

          -  Patients with any of the following conditions that impair the ability to swallow
             AZD0530 tablets

               -  Gastrointestinal tract disease resulting in an inability to take oral medication
                  or requiring IV alimentation

               -  Prior surgical procedures affecting absorption

               -  Active peptic ulcer disease

          -  Uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  Patients who have not recovered from adverse events due to agents administered more
             than 4 weeks earlier

          -  Use of specifically prohibited CYP3A4-active agents or substances

               -  Prohibited drugs should be discontinued 7 days prior to the administration of the
                  first dose of AZD0530 and for 7 days following discontinuation of AZD0530

          -  Patients receiving any other investigational agents

          -  No investigational or commercial agents or therapies other than study drugs may be
             administered with the intent to treat the patient's malignancy

          -  HIV-positive patients on combination antiretroviral therapy