Stage IIIA Bladder Cancer AJCC v8 Clinical Trial
Official title:
A Phase II Exploratory Study of Pre-Operative Treatment With Erlotinib (Tarceva) in Muscle Invasive or Recurrent Transitional Cell Carcinoma Requiring Cystectomy
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.
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.
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