Clinical Trials Directory

Trials / Completed

CompletedNCT00749892

Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer

A Phase II Exploratory Study of Pre-Operative Treatment With Erlotinib (Tarceva) in Muscle Invasive or Recurrent Transitional Cell Carcinoma Requiring Cystectomy

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
34 (actual)
Sponsor
M.D. Anderson Cancer Center · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Not accepted

Summary

This phase II trial studies how well erlotinib hydrochloride works in Treating participants with muscle invasive urothelial cancer or urothelial cancer that has come back. Drugs used in chemotherapy, such as erlotinib hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Detailed description

PRIMARY OBJECTIVES: I. To estimate the response rate (ie: pT0 rate) of patients with urothelial cancer treated with erlotinib prior to cystectomy. SECONDARY OBJECTIVES: I. To estimate the 4-year disease-free survival of patients with urothelial cancer treated with erlotinib prior to cystectomy. II. To measure epithelial-mesenchymal transition (EMT) markers (E-cadherin, HER4, PDGFR-beta, vimentin, fibronectin) in pre- and post-treatment biopsies and correlate expression patterns with the biological responses measured below. III. To quantify target inhibition, antiproliferation (KI-67), and apoptosis (terminal deoxynucleotidyl transferase dUTP nick end labeling \[TUNEL\]) in biopsies obtained from patients before, during, and after therapy. IV. Interrogate membrane (phosphorylated EGFR) and downstream receptor signaling pathways (ERKs, AKT/mTOR, GSK-3beta) to provide further insight into whether or not a given tumor displays a biological response. V. To correlate the changes in Ki-67 expression with changes in angiogenesis and angiogenesis related gene expression utilizing fluorescent tissue staining techniques that we have developed in the laboratory (such as two-color TUNEL, phosphor-receptor, and microvessel density.) VI. To profile messenger ribonucleic acid (mRNA) expression in pre- and post-treatment biopsies using Affymetrix arrays and correlate the changes observed with EMT, growth arrest, and apoptosis. VII. To quantify EGFR copy number and correlate with changes observed with EMT, growth arrest, and apoptosis. OUTLINE: Participants receive erlotinib hydrochloride orally (PO) once daily (QD) for 3-5 weeks in the absence of disease progression or unacceptable toxicity. Within 24 hours of the last dose, participants undergo cystectomy. After completion of study treatment, participants are followed up every 6 months for 1 year, then annually for 4 years.

Conditions

Interventions

TypeNameDescription
DRUGErlotinib HydrochlorideGiven PO

Timeline

Start date
2008-06-10
Primary completion
2019-06-30
Completion
2019-11-26
First posted
2008-09-09
Last updated
2020-09-10
Results posted
2020-09-10

Locations

1 site across 1 country: United States

Regulatory

Source: ClinicalTrials.gov record NCT00749892. Inclusion in this directory is not an endorsement.