Lapatinib in Treating Patients With Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: lapatinib ditosylate
Intervention description: 1500 mg, daily until disease progression
Intervention MeSH terms: Lapatinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage I prostate cancer; stage II prostate cancer; stage III prostate cancer; stage IV prostate cancer

Summary:

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

Eligibility criteria:

        Inclusion Criteria:

          -  Patients must have histologically confirmed diagnosis of adenocarcinoma of the
             prostate.

          -  On androgen deprivation therapy for prostate cancer (either bilateral orchiectomy or
             medical castration with the testosterone level of <50 ng/dl)

          -  Biochemical progression on androgen deprivation therapy with minimum PSA of 5 ng/ml.
             Progression is defined as two successive rises in PSA, measured at least one week
             apart. See section 4.1 for additional criteria.

          -  Minimum of 4-6 weeks off anti-androgen therapy (4 weeks for flutamide, 6 weeks for
             bicalutamide and nilutamide).

          -  Minimum of 4 weeks off other hormonal therapy (i.e. ketoconazole, megestrol acetate,
             aminoglutethimide)

          -  Minimum of 4 weeks from any prior radiation therapy, surgery, chemotherapy or other
             investigational agent.

          -  Patients must discontinue use of any herbal supplements prior to study initiation.

          -  No prior or concurrent exposure to cytotoxic chemotherapy.

          -  Age > 18 years.

          -  Life expectancy greater than 12 weeks

          -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-2

          -  Cardiac ejection fraction within the institutional range of normal as measured by
             echocardiogram or multigated acquisition scan (MUGA) scan.

          -  Men must agree to use adequate contraception (hormonal or barrier method of birth
             control or abstinence) prior to study entry and for the duration of study
             participation since the effects of GW572016 on the developing human fetus at the
             recommended therapeutic dose are unknown.

          -  Ability to swallow and retain oral medication.

          -  Ability to understand and the willingness to sign a written informed consent document.

        Exclusion Criteria:

          -  Patients who have had prior treatment with ErbB family targeting therapies.

          -  Patients who have not recovered from adverse events due to agents administered more
             than 4 weeks earlier.

          -  Prior chemotherapy for prostate cancer

          -  Patients with known brain metastases

          -  History of allergic reactions attributed to compounds of similar chemical or biologic
             composition to GW572016.

          -  Uncontrolled inter-current 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.

          -  A history of a positive HIV test in the past.

          -  Patients with GI tract disease resulting in an inability to take oral medication,
             malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures
             affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative
             colitis).

          -  Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors
             (please refer to section 3.2.2 for a list of medications).