Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer
Condition: Bladder Cancer
MeSH terms: Urinary Bladder Neoplasms
Intervention: Erlotinib; Radical Cystectomy
Intervention description: Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression; Will occur 4 weeks prior to dosing with erlotinib
Intervention MeSH terms: Erlotinib Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 27.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: stage II bladder cancer; transitional cell carcinoma of the bladder

Summary:

      RATIONALE: Erlotinib may stop the growth of tumor cells by blocking some of the enzymes
      needed for cell growth. Giving erlotinib before surgery may make the tumor smaller and reduce
      the amount of normal tissue that needs to be removed. Giving erlotinib after surgery may kill
      any tumor cells that remain after surgery.

      PURPOSE: This phase II trial is studying how well erlotinib works when given before and after
      surgery in treating patients with muscle-invasive bladder cancer.
    

Eligibility criteria:

        DISEASE CHARACTERISTICS:

          -  Histologically confirmed muscle-invasive bladder cancer, meeting the following
             criteria:

               -  Clinical stage T2 disease

               -  No locally-extensive clinical stage T3 or T4 disease

               -  No metastatic disease (N+, M+) by physical exam or radiologic evaluation

          -  Must have undergone prior initial or confirmatory transurethral resection of the
             bladder tumor (TURBT)

          -  Candidate for and has agreed to undergo radical cystectomy with curative intent

          -  No non-transitional cell carcinoma histologies

        PATIENT CHARACTERISTICS:

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2

          -  Granulocyte count > 1,500/mm³

          -  Platelet count > 100,000/mm³

          -  Bilirubin normal

          -  Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 2 times upper
             limit of normal

          -  Creatinine normal

          -  Not pregnant or nursing

          -  Negative pregnancy test

          -  Fertile patients must use effective contraception

          -  No contraindication to erlotinib hydrochloride or other tyrosine kinase inhibitors

        PRIOR CONCURRENT THERAPY:

          -  No prior radiotherapy or systemic chemotherapy for bladder cancer

               -  Prior single-dose mitomycin C allowed at the time of TURBT

          -  Prior 6- or 12-week course of adjuvant intravesical Bacillus Calmette-Guerin (BCG)
             therapy with or without recombinant interferon alfa-2a allowed

          -  At least 4 weeks since other prior or concurrent radiotherapy, chemotherapy, or
             hormonal therapy