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

Part of paid clinical trials in Chapel Hill, North Carolina.

Sponsor
UNC Lineberger Comprehensive Cancer Center
Study ID
NCT00380029
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Erlotinib — DRUG
    Erlotinib will be given at a dose of 150 mg per day for 4 weeks before undergoing planned radical cystectomy. In addition, patients will continue on erlotinib daily at a dose of 150 mg per day (qd dosing) for up to 2 years after surgery (beginning within 12 weeks of surgery) or until evidence of disease recurrence or progression
  • Radical Cystectomy — PROCEDURE
    Will occur 4 weeks prior to dosing with erlotinib

Study Details

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.

Key Dates

First listed
Sep 25, 2006
Start date
May 31, 2006
Status verified
Jun 2017
Primary completion
Aug 31, 2010
Completion
Jun 30, 2014

Study Design

Enrollment
27 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Erlotinib
    erlotinib given before and after transurethral resection of a bladder tumor, TURBT

Primary Outcome Measure

EGFR Activation Signal (AKT2) Expression to Predict Sensitivity to Erlotinib [ Time Frame: 4 weeks before treatment and 4 weeks post treatment ]

Locations (1)

FacilityCityStateZIPSite coordinators
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel HillNorth Carolina27599-7295-

Find similar trials in Chapel Hill, NC

By condition
Bladder cancer
By specialty
OncologyUrology
By research site
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill· Chapel Hill, NC

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