NCT02169284

Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery

Phase II Clinical Chemoprevention Trial of Weekly Erlotinib Before Bladder Cancer Surgery

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: National Cancer Institute (NCI) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Bladder Carcinoma
• Recurrent Bladder Carcinoma

Interventions

Type	Name	Description
DRUG	Erlotinib Hydrochloride	Given PO
OTHER	Laboratory Biomarker Analysis	Correlative studies
OTHER	Pharmacological Study	Correlative studies
OTHER	Placebo	Given PO
OTHER	Quality-of-Life Assessment	Ancillary studies
PROCEDURE	Therapeutic Conventional Surgery	Undergo TURBT or cystectomy

Timeline

• Start date: 2014-10-01
• Primary completion: 2018-03-30
• Completion: 2018-03-30
• First posted: 2014-06-23
• Last updated: 2020-07-07
• Results posted: 2020-07-07

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated drug study