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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
NCT04940299 -
Tocilizumab, Ipilimumab, and Nivolumab for the Treatment of Advanced Melanoma, Non-Small Cell Lung Cancer, or Urothelial Carcinoma
|
Phase 2 | |
| Recruiting |
NCT04953104 -
Nivolumab for the Treatment of Patients With Metastatic Urothelial Cancer With ARID1A Mutation and Stratify Response Based on CXCL13 Expression
|
Phase 2 | |
| Completed |
NCT03617913 -
Avelumab in Combination With Fluorouracil and Mitomycin or Cisplatin and Radiation Therapy in Treating Participants With Muscle-Invasive Bladder Cancer
|
Phase 2 | |
| Recruiting |
NCT06350734 -
Quality of Life After Treatment for Bladder Cancer: The Bladder Cancer Survivorship Study
|
||
| Recruiting |
NCT04383743 -
Pembrolizumab and Combination Chemotherapy Before Surgery for the Treatment of Muscle-Invasive Bladder Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT03775265 -
Chemoradiotherapy With or Without Atezolizumab in Treating Patients With Localized Muscle Invasive Bladder Cancer
|
Phase 3 | |
| Recruiting |
NCT05581589 -
Sacituzumab Govitecan Before Radical Cystectomy for the Treatment of Non-Urothelial Muscle Invasive Bladder Cancer
|
Phase 2 | |
| Not yet recruiting |
NCT06263153 -
Futibatinib in Combination With Durvalumab Prior to Cystectomy for the Treatment of Muscle-Invasive Bladder Cancer Patients Who Are Ineligible for Cisplatin-based Therapy
|
Phase 2 | |
| Completed |
NCT03319745 -
Pembrolizumab in Treating Patients With Bladder Cancer Undergoing Radical Cystectomy
|
Phase 2 | |
| Active, not recruiting |
NCT04501913 -
Remote Telemonitoring of Patient-Generated Physiologic Health Data and Patient-Reported Outcomes
|
||
| Recruiting |
NCT06040762 -
A Home-Based Prehabilitation Exercise Intervention for Improving Physical Function in Patients Receiving Chemotherapy Before Radical Cystectomy, Get Moving Trial
|
N/A | |
| Recruiting |
NCT04902040 -
Plinabulin in Combination With Radiation/Immunotherapy in Patients With Select Advanced Cancers After Progression on PD-1 or PD-L1 Targeted Antibodies
|
Phase 1/Phase 2 |