Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery

NCT02169284 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-07-07

Study results available
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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.

Conditions

  • Bladder Carcinoma
  • Recurrent Bladder Carcinoma

Interventions

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

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Tracy Downs · University of Wisconsin, Madison

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-01
Primary Completion
2018-03-30
Completion
2018-03-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02169284 on ClinicalTrials.gov