Clinical trial NCT00103194 (phase 2, status: completed)
Conditions: recurrent prostate cancer, stage i prostate cancer, stage iia prostate cancer, stage iib prostate cancer, stage iii prostate cancer
ICD codes: C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5, C61, D29.1, D40.0, Z15.03, Z80.42, Z85.46, Z12.5
Drugs: lapatinib ditosylate
SMILES: CS(=O)(=O)CCNCC1=CC=C(O1)C1=CC2=C(C=C1)N=CN=C2NC1=CC(Cl)=C(OCC2=CC(F)=CC=C2)C=C1
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