Erlotinib Before and After Surgery in Treating Patients With Muscle-Invasive Bladder Cancer

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center
• Collaborators: National Cancer Institute (NCI); OSI Pharmaceuticals
• Treatments: Erlotinib Hydrochloride

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