Gefitinib and Etoposide in Treating Patients With Advanced Prostate Cancer That Did Not Respond to Hormone Therapy
Condition: Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Gefitinib plus etoposide
Intervention description: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
Intervention MeSH terms: Etoposide; Gefitinib
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 26.0
Sex: Male
Minimum age: 19 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: adenocarcinoma of the prostate; recurrent prostate cancer; stage III prostate cancer; stage IV prostate cancer

Summary:

      RATIONALE: Gefitinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth and by blocking blood flow to the tumor. Drugs used in chemotherapy,
      such as etoposide, work in different ways to stop the growth of tumor cells, either by
      killing the cells or by stopping them from dividing. Giving gefitinib together with etoposide
      may kill more tumor cells.

      PURPOSE: This phase II trial is studying how well giving gefitinib together with etoposide
      works in treating patients with advanced prostate cancer that did not respond to hormone
      therapy.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Histologically confirmed adenocarcinoma of the prostate

          -  Progressive disease after a prior docetaxel-based regimen OR failed a prior
             docetaxel-based regimen

          -  Hormone-refractory disease, meeting 1 of the following criteria:

          -  Radiologically measurable disease

          -  Prostate-specific antigen (PSA) progression* while on hormonal therapy (including
             withdrawal from a direct antagonist) NOTE: *If the confirmatory PSA value is less than
             the screening PSA value, then an additional test for rising PSA is required to
             document progression

          -  Must have undergone prior surgical castration OR currently be on a luteinizing
             hormone-releasing hormone agonistANC > 1,500/mm³Platelet count > 100,000/mm³Hemoglobin
             > 10 g/dL (in the absence of packed red blood cell transfusions within the past 4
             weeks)Creatinine < 2 mg/dLAST and ALT < 2 times upper limit of normal (ULN)Alkaline
             phosphatase < 2 times ULNFertile patients must use effective double-method
             contraception during and for 1 month after completion of study treatmentAt least 4
             weeks since prior cytotoxic therapy

          -  At least 4 weeks since prior direct antagonists, including flutamide and nilutamide

          -  At least 6 weeks since prior bicalutamide

          -  At least 30 days since prior nonapproved or investigational drugs

          -  More than 4 weeks since prior palliative radiotherapy o The irradiated lesion must not
             be used to assess response rate

        Exclusion Criteria:

          -  No other malignancy within the past 5 years except basal cell carcinoma

          -  No clinically significant New York Heart Association class II-IV cardiovascular
             disease

          -  No evidence of severe or uncontrolled systemic disease (e.g., unstable or
             uncompensated respiratory, cardiac, hepatic, or renal disease)

          -  No unresolved chronic toxicity > grade 2 from prior anticancer therapy, with the
             exception of alopecia

          -  No other significant clinical disorder or laboratory finding that would preclude study
             participation

          -  No known severe hypersensitivity to gefitinib or any of the excipients of this product

          -  No evidence of clinically active interstitial lung disease

             o Asymptomatic Patients with chronic, stable radiographic changes are eligible

          -  No prior gefitinib or etoposide

          -  No concurrent palliative radiotherapy

          -  No concurrent chemotherapeutic agents

          -  No concurrent phenytoin, carbamazepine, rifampin, barbiturates, or Hypericum
             perforatum (St. John's wort)

          -  No concurrent hormones except antiandrogen therapy, steroids for adrenal failure,
             hormones for nondisease-related conditions (e.g., insulin for diabetes), or
             intermittent dexamethasone as an antiemetic

          -  No concurrent initiation of IV and/or oral bisphosphonates specifically for
             symptomatic bone metastases