Neoplasms

All Conditions

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Recurrence

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urethral Neoplasms

Ureteral Neoplasms

Pelvic Neoplasms

Kidney Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Disease Attributes

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Urethral Diseases

Ureteral Diseases

Kidney Diseases

Transitional Cell Carcinoma

Urethral Cancer

Antineoplastic Agents

All Drugs and Chemicals

Amino Acids

Erlotinib Hydrochloride

Tyrosine Kinase Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

Participants receive erlotinib hydrochloride PO QD for 3-5 weeks in the absence of disease progression or unacceptable toxicity. Within 24 hours of the last dose, participants undergo cystectomy.

Arlene Siefker-Radtke

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.

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

The response rate is the number of patients with urothelial cancer treated with erlotinib prior to cystectomy. The response is defined as the absence of residual cancer in the surgical removed tissue (i.e., pT0). A responder is defined as a participant with the pathological stage of pT0 meaning that there is no evidence of disease.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Toxicities were measured at weekly visit while on therapy using the NCI CTCAE v3.0.

Erlotinib 150 mg by mouth daily for 3 weeks followed by cystectomy within 24 hours of the last dose.

Pre-surgical Erlotinib Treatment

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

cTaN0

cT1N0

cT2N0

cT3aN0

cT3bN0

cT4aN0

Participants were staged clinically before treatment began. The T describes the tumor size; the larger the number is the more advanced the disease. The N indicates the lymphnode involvement; zero indicates that no lymph nodes were believed to be cancerous.

Three particpants withdrew from study treatment.

Clinical Staging

Participants were stagged clinically before treatment began. The T discribes the tumor size; the larger the number is the more advanced the disease. The N indicates the lymphpnode involvemnt; zero indicates that no lymph nodes were believed to be cancerous.

Dr. Arlene O. Siefker-Radtke,Professor, Genitourinary Medical Oncology

Number of Responders

Number of Non Responders

two participants did not take any eroltinib and three participants stopped erlotinib early due to intolerable side effects.

Response Rate

Estimated 4-Year Disease-Free Survival

Overall Study

Gemcitabine

Antimetabolites

Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.

Gemcitabine Hydrochloride

Stephen A Boorjian

This phase II trial studies how well gemcitabine works in preventing urothelial cancer from coming back within the bladder (intravesical recurrence) in patients with upper urinary tract urothelial cancer undergoing radical nephroureterectomy. Drugs used in chemotherapy, such as gemcitabine, 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. Instilling gemcitabine into the bladder during surgery, may reduce the chance of recurrence of upper urinary tract urothelial cancer.

PRIMARY OBJECTIVE:

I. To determine the efficacy of a single intraoperative intravesical instillation of gemcitabine hydrochloride (gemcitabine) at time of radical nephroureterectomy (RNU) for clinically localized upper tract urothelial carcinoma (UTUC) in preventing intravesical recurrence of urothelial cancer (UC) at one year.

SECONDARY OBJECTIVES:

I. To assess time to recurrence for entire duration of follow-up. II. To assess the qualitative and quantitative toxicities.

EXPLORATORY OBJECTIVES:

I. To stratify intravesical UC recurrence free survival by tumor grade, neoadjuvant chemotherapy, tumor stage, ureteral tumor location, and history of bladder cancer.

II. To assess incidence and time to development of muscle-invasive bladder cancer (MIBC).

OUTLINE:

Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.

After completion of study, patients are followed up at 2 weeks, and 3, 6, 12, 18, and 24 months.

Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study

GEMINI: An Open-Label, Single-Arm, Phase II Study of Intraoperative Gemcitabine Intravesical Instillation in Patients Undergoing Radical Nephroureterectomy for Upper Tract Urothelial Carcinoma

Number of subject to experience muscle-invasive bladder cancer. Assessed by Urothelial Carcinoma on final pathology of Transurethral Resection of Bladder Tumor specimen or Urothelial Carcinoma on final pathology of radical cystectomy specimen.

Defined as the time (days) from date of Radical Nephroureterectomy to date of histologic proof of Urothelial Carcinoma

Defined as the time (days) from date of Radical Nephroureterectomy to date of death

Number of participants without recurrence of Urothelial Carcinoma. Relapse-free survival will be assessed by cystoscopy and urine cytology.

Number of days from Radical Nephroureterectomy to date of histologic proof of recurrence/relapse of Urothelial Carcinoma

Adverse events will be categorized by grade and further distinguished as serious adverse events. Furthermore, they will be designated by each site as not related, unlikely, possible, probably, and definitely related to treatment adverse events. they will also be summarized and organized by organ system, with the number and percent of patients experiencing the adverse event at least once and the number of patients exposed. Adverse events will be described and analyzed qualitatively. Adverse events will be grouped into categories and numerically described.

Mayo Clinic

Principal Investigator

Patients receive gemcitabine hydrochloride intravesically for at least 1 hour at the time of RNU.

Gemcitabine Hydrochloride: Given intravesically

Prevention (Gemcitabine Hydrochloride)

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

Study target enrollment was anticipated for 90 participants but only 23 participants completed treatment before study was terminated. The study was terminated due to insufficient resources and funding to support continuation of the trial. PI decision to terminate.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer	NCT00749892	Recurrent Bladd... Recurrent Renal... Recurrent Urete... Recurrent Ureth... Stage 0a Bladde... Stage 0a Renal ... Stage 0a Ureter... Stage 0a Urethr... Stage 0is Bladd... Stage 0is Renal... Stage 0is Urete... Stage 0is Ureth... Stage II Bladde... Stage II Renal ... Stage II Ureter... Stage II Urethr... Stage III Renal... Stage III Urete... Stage III Ureth... Stage IIIA Blad...	Erlotinib Hydro...	19 Years -	M.D. Anderson Cancer Center
Erlotinib Hydrochloride in Treating Participants With Muscle Invasive or Recurrent Urothelial Cancer	NCT00749892	Recurrent Bladd... Recurrent Renal... Recurrent Urete... Recurrent Ureth... Stage 0a Bladde... Stage 0a Renal ... Stage 0a Ureter... Stage 0a Urethr... Stage 0is Bladd... Stage 0is Renal... Stage 0is Urete... Stage 0is Ureth... Stage II Bladde... Stage II Renal ... Stage II Ureter... Stage II Urethr... Stage III Renal... Stage III Urete... Stage III Ureth... Stage IIIA Blad...	Erlotinib Hydro...	19 Years -	M.D. Anderson Cancer Center
Gemcitabine for the Prevention of Intravesical Recurrence of Urothelial Cancer in Patients With Upper Urinary Tract Urothelial Cancer Undergoing Radical Nephroureterectomy, GEMINI Study	NCT04398368	Stage 0a Renal ... Stage 0a Renal ... Stage 0a Ureter... Stage 0is Renal... Stage 0is Renal... Stage 0is Urete... Stage I Renal P... Stage I Renal P... Stage I Ureter ... Stage II Renal ... Stage II Renal ... Stage II Ureter... Stage III Renal... Stage III Renal... Stage III Urete... Stage IV Renal ... Stage IV Renal ... Stage IV Ureter...	Gemcitabine Hyd...	18 Years -	Mayo Clinic

Spots Global Cancer Trial Database for stage 0is renal pelvis cancer ajcc v8