Single Agent Erlotinib in Chemotherapy-naive Androgen Independent Prostate Cancer
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Tarceva
Intervention description: 150mg QD
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 29.0
Sex: Male
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      Objectives to evaluate the activity of Erlotinib in prostate cancer patients who are hormone
      refractory and androgen independent and have not been exposed to chemotherapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Documented prostate cancer regardless of Gleason score

          -  Patients should be considered hormone refractory and androgen independent. They must
             fail LHRH analogues, and anti-androgen withdrawal trial.

          -  Failure is confirmed by an increase in PSA value of 10% or more than the value
             immediately before, and confirmed by another assessment 2 weeks later.

          -  Patients have to have measurable disease either biochemically using rising PSA or/and
             with metastatic disease to the bone or visceral organs.

          -  Performance status of 2 or less using ECOG scale.· Adequate liver function tests with
             ALT/AST being < 3x normal, total bilirubin of 1.5 or less, and adequate renal function
             measured by a creatinine of 2.0 mg/dl or less. Alkaline phosphatase values are never
             exclusion criteria if it is deemed related to bone metastases.

          -  Patients need to have adequate bone marrow function. ANC of 1000 or above, Hgb of 9.0
             g/dl or above, and platelets of 100,000 or above. If other causes are affecting plts
             counts such as autoimmune disorders, patients are allowed on study.

          -  Patients with inadequate bone marrow function that is deemed related to bone marrow
             involvement with prostate cancer are allowed at the investigator's discretion.

          -  Patients with other malignancies are allowed as long as there is no evidence of the
             other malignancy present at entry time, and it has been 3 years or more since the
             treatment for the other disorder was completed.

          -  Patients with prior exposure to investigational therapies including vaccines are
             allowed on this study as long as their last exposure was 4 weeks prior to study
             entry.Patients with known bone metastases are allowed to receive intravenous
             bisphosphonates such as aredia or zometa.

          -  Patients on oral bisphosphonates are also allowed.

          -  Chemo Naive

        Exclusion Criteria:

          -  Patients with prior exposure to Tarceva

          -  Patients who have received any prior systemic chemotherapy for prostate cancer.
             Exposure to chemotherapy for other malignancies is allowed as long as last
             chemotherapy was completed 3 years prior to study entry.

          -  Patients with prior malignancies are excluded except for those who have non-melanoma
             skin cancers or other cancers that are in remission with the last therapy given 3
             years prior to enrollment.

          -  Prior exposure to any form of steroids is allowed and is not considered exclusion
             criteria.

          -  Performance status of 3 or above using ECOG scale.

          -  Known HIV positive status Known CNS involvement with prostate cancer