Erlotinib Hydrochloride in Treating Patients With Bladder Cancer Undergoing Surgery

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
National Cancer Institute (NCI)
Study ID
NCT02169284
Phase
PHASE2
Status
Terminated

Conditions

  • Bladder Carcinoma
  • Recurrent Bladder Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
Oct 1, 2014
Status verified
Jun 2020
Primary completion
Mar 30, 2018
Completion
Mar 30, 2018

Study Design

Enrollment
50 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group I (erlotinib hydrochloride)
    Patients receive erlotinib hydrochloride PO QD on days 1, 8, and 15. Patients then undergo TURBT or cystectomy on day 16.
  • Placebo Comparator: Group II (placebo)
    Patients receive placebo PO QD on days 1, 8, and 15. Patients then undergo TURBT or cystectomy on day 16.

Primary Outcome Measure

EGFR Phosphorylation in Normal Appearing Bladder Epithelium Adjacent to Tumor [ Time Frame: Up to 18 hours after last study drug dose (on day 28) ]

Locations (6)

FacilityCityStateZIPSite coordinators
Johns Hopkins University/Sidney Kimmel Cancer CenterBaltimoreMaryland21287-
Lahey Hospital and Medical CenterBurlingtonMassachusetts01805-
University of RochesterRochesterNew York14642-
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572-
Urology San Antonio Research PASan AntonioTexas78229-
University of Wisconsin Hospital and ClinicsMadisonWisconsin53792-

Find similar trials in Baltimore, MD

By research site
Johns Hopkins University/Sidney Kimmel Cancer Center· Baltimore, MDLahey Hospital and Medical Center· Burlington, MAUniversity of Rochester· Rochester, NYCarolina Urologic Research Center· Myrtle Beach, SCUrology San Antonio Research PA· San Antonio, TXUniversity of Wisconsin Hospital and Clinics· Madison, WI

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