Saracatinib in Treating Patients With Prostate Cancer
Condition: Hormone-resistant Prostate Cancer; Recurrent Prostate Cancer; Stage IV Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: saracatinib; hydrocortisone/placebo
Intervention description: Given orally; Given orally
Intervention MeSH terms: Hydrocortisone; Saracatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 31.0
Sex: Male
Healthy volunteers: No

Summary:

      This randomized phase II clinical trial is studying how well saracatinib works in treating
      patients with prostate cancer. Saracatinib 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 progressive disease;
             progressive disease may be defined as either

               -  New clinical or radiographic metastases

               -  Rising PSA: PSA must be greater than 1.0 ng/mL with at least 2 consecutive rises
                  after completion of prior therapy; the PSA values documenting these rises should
                  be separated by no less than 10 days; the baseline PSA value may be taken from
                  the end of prior therapy

          -  Previous treatment with docetaxel for disease progression following hormonal therapy
             (i.e., castrate-resistant disease) required

               -  Treatment in the adjuvant or neoadjuvant setting will NOT be grounds for
                  inclusion unless docetaxel has been used again in the setting of progressive CRPC

          -  ECOG performance status 0-1

          -  ANC ≥ 1,500/mm³

          -  Hemoglobin > 9.0 g/dL

          -  Platelet count > 100,000/mm³

          -  Total bilirubin < 2.0 x institutional ULN

          -  AST/ALT < 5 x institutional ULN in the presence of bone/liver metastases

          -  Serum creatinine (Cr) within ULN

               -  Patients with Cr > ULN must have a Cr clearance of > 60 mL/min

          -  Testosterone 50 ng/mL or lower if a patient is receiving an LHRH agonist

               -  No testosterone testing is required for men who have undergone surgical
                  orchiectomy

          -  Fertile patients must agree to abstinence or some adequate form of contraception

          -  No patients with any condition (e.g., gastrointestinal tract disease resulting in an
             inability to take oral medication or a requirement for IV alimentation, prior surgical
             procedures affecting absorption, or active peptic ulcer disease) that impairs the
             ability to swallow AZD0530 tablets

          -  No history of uncontrolled or unstable cardiac dysrhythmia

          -  No resting ECG with measurable QTc interval of > 480 msec at 2 or more time points
             within a 24-hour period

          -  No evidence of interstitial lung disease (bilateral, diffuse, parenchymal lung
             disease)

               -  A high-resolution CT of the chest will be required during screening

          -  No evidence of severe or uncontrolled systemic conditions (e.g., severe hepatic
             impairment) or current unstable or uncompensated respiratory or cardiac conditions
             which makes it undesirable for the patient to participate in the study or which could
             jeopardize compliance with the protocol

          -  No patients with a known immunodeficiency syndrome

          -  No patients with a history of allergic reactions attributed to compounds of similar
             chemical or biologic composition to AZD0530

          -  No patients receiving any other investigational agents

          -  Previous AZD0530 exposure is allowed provided that the patient did not show
             radiographic progression during treatment

          -  Patients receiving non-steroidal anti-androgens (e.g., flutamide) or other hormonal
             treatment (such as ketoconazole, abiraterone, or TAK-700) must have stopped these
             drugs at least 28 days prior to enrollment for flutamide or ketoconazole, or at least
             42 days prior to enrollment for bicalutamide or nilutamide, and the patients must have
             demonstrated progression of disease since the agents were suspended

          -  Patients should be at least 2 weeks away from previous chemotherapy, surgery, or
             radiotherapy

          -  No unresolved toxicity from previous treatments that are CTCAE grade 2 from previous
             anti-cancer therapy (except alopecia)

          -  Patients who are currently on zoledronic acid (Zometa) or other bisphosphonate therapy
             are eligible provided that they have been on therapy at least 6 weeks prior to
             participation

               -  Increases in bisphosphonate dosing will not be allowed (i.e., starting within 6
                  weeks or changing from every 3-month to every 1-month dosing)

          -  Use of specifically prohibited CYP3A4-active agents or substances are not permitted
             during protocol treatment, and patients who must continue treatment with these agents
             are not eligible

               -  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 (unless
                  otherwise specified)

          -  No concurrent use of non-FDA approved medications