Lapatinib Ditosylate in Treating Patients With a Rising PSA Indicating Recurrent Prostate Cancer
Condition: Recurrent Prostate Cancer; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer; Stage III Prostate Cancer
MeSH terms: Prostatic Neoplasms; Recurrence
Intervention: lapatinib ditosylate; laboratory biomarker analysis
Intervention description: Given PO; Correlative studies
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 49.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This phase II trial studies how well lapatinib ditosylate works in treating patients with a
      rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that
      prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the
      growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or
      prevent the progression of prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed diagnosis of prostate cancer

          -  Previous treatment with definitive surgery or radiation therapy

          -  Prior salvage therapy (surgery, radiation, or other local ablative procedures) is
             allowed if the intent was for cure

          -  No evidence of metastatic disease on physical exam, computed tomography (CT) (magnetic
             resonance imaging [MRI]), and bone scan

          -  Prior neoadjuvant/adjuvant hormonal or chemotherapy and investigational agents are
             allowed if it was last used >= 1 year prior to enrollment (no prior
             vaccine/immunotherapy for prostate cancer will be allowed)

          -  No therapy modulating testosterone levels (such as luteinizing-hormone
             releasing-hormone agonists/antagonists and antiandrogens) is permitted within 1 year
             prior to enrollment; agents such as 5alpha-reductase inhibitors, ketoconazole,
             megestrol acetate, systemic steroids, or herbal supplements are not permitted at any
             time during the period that the PSA values are being collected

          -  Hormone-sensitive prostate cancer as evident by a serum total testosterone level > 150
             ng/dL within 4 weeks prior to registration

          -  All patients must have evidence of biochemical progression as determined by a
             reference PSA value followed by 2 rising PSA values, each higher than the previous
             value, obtained at least 6 weeks apart; all of these PSA values must be obtained at
             the same reference lab, and all must be done within 6 months prior to enrollment

          -  The most recent of the PSA values must be greater than 0.4 ng/ml (after prostatectomy)
             or greater than 1.5 ng/ml (after radiation therapy) at time of enrollment; this
             measurement must be obtained within 6 months prior to enrollment

          -  PSA doubling time (PSADT) must be =< 365 days

          -  Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

          -  Leukocytes >= 3000/mm^3

          -  Granulocytes >= 1500/mm^3

          -  Platelet count >= 100,000/mm^3

          -  Serum creatinine within normal institutional limits or creatinine clearance >= 60
             mL/min/1.73 m^2 for patients with creatinine levels above institutional normal

          -  Serum total bilirubin within normal institutional limits

          -  Serum alkaline phosphatase within normal institutional limits

          -  Serum glutamic oxaloacetic transaminase (SGOT) (aspartate aminotransferase [AST]) and
             serum glutamic pyruvate transaminase (SGPT) (alanine aminotransferase [ALT]) =< 2.5 x
             institutional upper limit of normal

          -  Cardiac ejection fraction within the institutional range of normal, as measured by
             echocardiogram or multi gated acquisition scan (MUGA) scan within 4 weeks prior to
             registration; note that baseline and on-treatment scans should be performed using the
             same modality and preferably at the same institution

          -  No unstable arrhythmias on electrocardiogram (ECG) are allowed (rate controlled,
             asymptomatic atrial fibrillation is allowed)

          -  No concomitant use of any medication classified as cytochrome P450 family 3, subfamily
             A, polypeptide 4 (CYP3A4) inducer or inhibitor; for patients previously treated with
             one of these prohibited medications, the prohibited agent needs to be discontinued,
             either 7 days, 14 days, or 6 months prior to the administration of the first dose of
             study medication

          -  Human immunodeficiency virus (HIV)-positive patients receiving combination
             anti-retroviral therapy are excluded from the study; appropriate studies will be
             undertaken in patients receiving combination anti-retroviral therapy when indicated

          -  Normal prothrombin time (PT)/international normalized ratio (INR) within 4 weeks prior
             to registration

          -  Able to swallow and retain oral medication

          -  Patients with gastrointestinal (GI) tract disease resulting in an inability to take
             oral medication, malabsorption syndrome, a requirement for intravenous (IV)
             alimentation, prior surgical procedures affecting absorption, uncontrolled
             inflammatory GI disease (e.g., Crohn's, ulcerative colitis) will not be eligible

          -  Sexually active males are strongly advised to use an accepted and effective method of
             contraception

          -  Patients may not be receiving any other investigational agents or receiving concurrent
             anticancer therapy

          -  No history of allergic reactions attributed to compounds of similar chemical or
             biologic composition to GW572016

          -  No uncontrolled intercurrent illness including, but not limited to, ongoing or active
             infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
             arrhythmia, or psychiatric illness/social situations that would limit compliance with
             study requirements

          -  No other malignancies permitted within the past 5 years with the exception of
             non-melanoma skin cancer treated with curative intent