Bladder Carcinoma Clinical Trial
Official title:
Phase II Clinical Chemoprevention Trial of Weekly Erlotinib Before Bladder Cancer Surgery
This randomized phase II trial studies how well erlotinib hydrochloride works in treating patients with bladder cancer undergoing surgery. Erlotinib hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PRIMARY OBJECTIVES:
I. To determine if there is a difference in EGFR phosphorylation in normal appearing bladder
epithelium adjacent to tumor approximately 9-18 hours post-study dose, between patients
randomized to erlotinib hydrochloride (erlotinib) weekly as compared to placebo.
SECONDARY OBJECTIVES:
I. Assess the tolerance of high dose weekly erlotinib compared to placebo. II. Assess the
expression of phosphorylated EGF receptor in tumor tissue when available.
III. Assess the expression of e-cadherin and Ki67 in normal and abnormal urothelium.
IV. Assess the expression of phosphorylated ERK in normal and abnormal urothelium.
V. Assess limited pharmacokinetics of weekly erlotinib. VI. Assess the expression of p53 in
normal and abnormal urothelium. VII. Assess the expression of let-7 in normal and abnormal
urothelium. VIII. Exploratory assessment of urination symptoms in men.
OUTLINE: Patients are randomized to 1 of 2 treatment groups.
GROUP I: Patients receive erlotinib hydrochloride orally (PO) once daily (QD) on days 1, 8,
and 15. Patients then undergo transurethral resection of bladder tumor (TURBT) or cystectomy
on day 16.
GROUP II: Patients receive placebo PO QD on days 1, 8, and 15. Patients then undergo TURBT or
cystectomy on day 16.
After completion of study treatment, patients are followed up for 7-14 days.
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