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RECRUITING

NCT03609216

PHASE2

Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

Sponsor: Alliance for Clinical Trials in Oncology

View on ClinicalTrials.gov

Summary

This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, 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.

Official title: A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

271

Start Date

2018-12-10

Completion Date

2029-02-01

Last Updated

2026-03-04

Healthy Volunteers

Conditions

Infiltrating Bladder Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma Stage III Bladder Urothelial Carcinoma

Interventions

DRUG

Gemcitabine Hydrochloride

Given IV

DRUG

Cisplatin

Given IV

BIOLOGICAL

Pegfilgrastim

Given SC

PROCEDURE

Conventional Surgery

Undergo bladder sparing

PROCEDURE

Radical Cystectomy

Undergo radical cystectomy

OTHER

Chemoradiotherapy

Undergo chemoradiotherapy

Inclusion Criteria: * Step 1 Patient Registration Eligibility Criteria * Histologically confirmed muscle-invasive urothelial carcinoma of the bladder. Urothelial carcinoma invading into the prostatic stroma with no histologic muscle invasion is allowed, provided the extent of disease is confirmed via imaging and/or examination under anesthesia (EUA). The diagnostic TURBT sample must have been obtained within 60 days prior to registration * 20 unstained slides (10 micron thickness) of formalin-fixed paraffin-embedded (FFPE) pre-treatment diagnostic transurethral resection (TUR) specimen available (for sequencing), with 2 (5 micron) slides at the start and end of the 20 slides, for a total of 22 unstained slides. An FFPE block is also acceptable * Clinical stage T2-T4aN0/xM0 disease * Medically appropriate candidate for radical cystectomy as assessed by surgeon * No concomitant multifocal carcinoma in situ; a single focus is allowed * A single muscle-invasive bladder tumor measuring ≤5 cm in size as defined by the surgeons at cystoscopic evaluation. When documented, pathologic size at cystoscopy and TURBT will take precedence over radiographic measurements of tumor size. * No clinical or radiographic evidence for locally advanced or metastatic disease * No prior anti-PD-1 or anti PD-L1 therapies, or systemic chemotherapy within the past 5 years (prior intravesical induction immunotherapy for non-muscle invasive disease is allowed, defined as BCG x6 doses and maintenance therapy); BCG refractory disease, defined as disease recurrence within 3 months of BCG therapy, is not allowed. Intravesical chemotherapy is allowed. * No prior radiation therapy to the bladder or prostate * No major surgery or radiation therapy =\< 4 weeks of registration (TURBT is allowed). * Not pregnant and not nursing. This study involves an agent that has known genotoxic, mutagenic and teratogenic effects. For women of childbearing potential only, a negative pregnancy test done =\< 14 days prior to registration is required * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Absolute neutrophil count (ANC) \>= 1,000/mm\^3 * Platelet count \>= 100,000/mm\^3 * Calculated creatinine clearance ≥ 55 mL/min using formula per institutional standard or investigator's discretion. The same formula should be used to calculate all subsequent creatinine clearances. * Total bilirubin =\< 1.5 x upper limit of normal (ULN) \* (For patients with documented Gilbert's syndrome Total Bilirubin =\< 3 x ULN) * Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =\< 2.5 x ULN * Alkaline phosphatase =\< 2.5 x ULN * No evidence of New York Heart Association (NYHA) functional class III or IV heart disease * No ongoing cardiac dysrhythmias of National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 grade \>= 2 * No pre-existing sensory grade \>= 2 neuropathy * No pre-existing grade \>= 2 hearing loss * No serious intercurrent medical or psychiatric illness, including serious active infection * None of the following within the 6 months prior to study drug administration: myocardial infarction, severe/unstable angina, coronary/peripheral artery bypass graft, symptomatic congestive heart failure, cerebrovascular accident, or transient ischemic attack * No known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS)-related illness or other active infection. HIV-positive patients on combination antiretroviral therapy are ineligible because of the potential for pharmacokinetic interactions with the drugs used in this trial. In addition, these patients are at increased risk of lethal infections when treated with marrow-suppressive therapy. Appropriate studies will be undertaken in patients receiving combination antiretroviral therapy, when indicated * No history of allergic reaction attributed to compounds of similar chemical or biologic composition to the agents used in this study * No concurrent treatment on another clinical trial; supportive care trials or non-therapeutic trials (e.g., quality of life) are allowed * No prior malignancy except for: adequately treated basal or squamous cell skin cancer, in situ cervical cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease free for five years. Patients with localized prostate cancer who are being followed by an active surveillance program are also eligible * Step 2 Patient Registration Eligibility Criteria * Patients must have completed 4 or more cycles of protocol-directed chemotherapy and DDR gene results must be available * Step 3 Patient Registration Eligibility Criteria (only patients with a DDR gene alteration) * Deleterious alteration within 1 or more of 9 pre-defined DDR genes within the pre-treatment TURBT deoxyribonucleic acid (DNA) * Cystoscopy and imaging performed to determine stage/treatment assignment

Locations (424)

Fairbanks Memorial Hospital

Fairbanks, Alaska, United States

CTCA at Western Regional Medical Center

Goodyear, Arizona, United States

Cancer Center at Saint Joseph's

Phoenix, Arizona, United States

Mercy Hospital Fort Smith

Fort Smith, Arkansas, United States

CHI Saint Vincent Cancer Center Hot Springs

Hot Springs, Arkansas, United States

University of Arkansas for Medical Sciences

Little Rock, Arkansas, United States

Mission Hope Medical Oncology - Arroyo Grande

Arroyo Grande, California, United States

Mercy Cancer Center - Carmichael

Carmichael, California, United States

Mercy San Juan Medical Center

Carmichael, California, United States

Mercy Cancer Center - Elk Grove

Elk Grove, California, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

Contra Costa Regional Medical Center

Martinez, California, United States

Fremont - Rideout Cancer Center

Marysville, California, United States

Mercy Cancer Center

Merced, California, United States

Mercy Cancer Center - Rocklin

Rocklin, California, United States

Mercy Cancer Center - Sacramento

Sacramento, California, United States

University of California Davis Comprehensive Cancer Center

Sacramento, California, United States

Pacific Central Coast Health Center-San Luis Obispo

San Luis Obispo, California, United States

Mission Hope Medical Oncology - Santa Maria

Santa Maria, California, United States

Saint Joseph's Medical Center

Stockton, California, United States

BASS Medical Group - Lennon

Walnut Creek, California, United States

Woodland Memorial Hospital

Woodland, California, United States

Rocky Mountain Cancer Centers-Aurora

Aurora, Colorado, United States

The Medical Center of Aurora

Aurora, Colorado, United States

Rocky Mountain Cancer Centers-Boulder

Boulder, Colorado, United States

Penrose-Saint Francis Healthcare

Colorado Springs, Colorado, United States

Rocky Mountain Cancer Centers-Penrose

Colorado Springs, Colorado, United States

Saint Francis Cancer Center

Colorado Springs, Colorado, United States

AdventHealth Porter

Denver, Colorado, United States

Presbyterian - Saint Lukes Medical Center - Health One

Denver, Colorado, United States

CommonSpirit Cancer Center Mercy

Durango, Colorado, United States

Mercy Medical Center

Durango, Colorado, United States

Mountain Blue Cancer Care Center - Swedish

Englewood, Colorado, United States

Swedish Medical Center

Englewood, Colorado, United States

The Melanoma and Skin Cancer Institute

Englewood, Colorado, United States

Mountain Blue Cancer Care Center

Golden, Colorado, United States

Banner North Colorado Medical Center

Greeley, Colorado, United States

Rocky Mountain Cancer Centers-Lakewood

Lakewood, Colorado, United States

Saint Anthony Hospital

Lakewood, Colorado, United States

Rocky Mountain Cancer Centers-Littleton

Littleton, Colorado, United States

AdventHealth Littleton

Littleton, Colorado, United States

Sky Ridge Medical Center

Lone Tree, Colorado, United States

Longmont United Hospital

Longmont, Colorado, United States

Rocky Mountain Cancer Centers-Longmont

Longmont, Colorado, United States

Banner North Colorado Medical Center - Loveland Campus

Loveland, Colorado, United States

AdventHealth Parker

Parker, Colorado, United States

Rocky Mountain Cancer Centers-Parker

Parker, Colorado, United States

Saint Mary Corwin Medical Center

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers - Pueblo

Pueblo, Colorado, United States

Rocky Mountain Cancer Centers-Thornton

Thornton, Colorado, United States

Saint Anthony North Hospital

Westminster, Colorado, United States

Hartford Hospital

Hartford, Connecticut, United States

Midstate Medical Center

Meriden, Connecticut, United States

The Hospital of Central Connecticut

New Britain, Connecticut, United States

William Backus Hospital

Norwich, Connecticut, United States

Holy Cross Hospital

Fort Lauderdale, Florida, United States

UF Health Cancer Institute - Gainesville

Gainesville, Florida, United States

Saint Alphonsus Cancer Care Center-Boise

Boise, Idaho, United States

Saint Alphonsus Cancer Care Center-Caldwell

Caldwell, Idaho, United States

Kootenai Health - Coeur d'Alene

Coeur d'Alene, Idaho, United States

Walter Knox Memorial Hospital

Emmett, Idaho, United States

Idaho Urologic Institute-Meridian

Meridian, Idaho, United States

Saint Alphonsus Cancer Care Center-Nampa

Nampa, Idaho, United States

Kootenai Clinic Cancer Services - Post Falls

Post Falls, Idaho, United States

Kootenai Clinic Cancer Services - Sandpoint

Sandpoint, Idaho, United States

OSF Saint Anthony's Health Center

Alton, Illinois, United States

Rush-Copley Medical Center

Aurora, Illinois, United States

Illinois CancerCare-Bloomington

Bloomington, Illinois, United States

Illinois CancerCare-Canton

Canton, Illinois, United States

Memorial Hospital of Carbondale

Carbondale, Illinois, United States

SIH Cancer Institute

Carterville, Illinois, United States

Illinois CancerCare-Carthage

Carthage, Illinois, United States

Centralia Oncology Clinic

Centralia, Illinois, United States

Saint Mary's Hospital

Centralia, Illinois, United States

University of Illinois

Chicago, Illinois, United States

Carle at The Riverfront

Danville, Illinois, United States

Cancer Care Specialists of Illinois - Decatur

Decatur, Illinois, United States

Decatur Memorial Hospital

Decatur, Illinois, United States

Illinois CancerCare-Dixon

Dixon, Illinois, United States

Carle Physician Group-Effingham

Effingham, Illinois, United States

Crossroads Cancer Center

Effingham, Illinois, United States

Illinois CancerCare-Eureka

Eureka, Illinois, United States

Illinois CancerCare-Galesburg

Galesburg, Illinois, United States

Western Illinois Cancer Treatment Center

Galesburg, Illinois, United States

Ingalls Memorial Hospital

Harvey, Illinois, United States

Illinois CancerCare-Kewanee Clinic

Kewanee, Illinois, United States

Illinois CancerCare-Macomb

Macomb, Illinois, United States

Carle Physician Group-Mattoon/Charleston

Mattoon, Illinois, United States

SSM Health Good Samaritan

Mount Vernon, Illinois, United States

Cancer Care Center of O'Fallon

O'Fallon, Illinois, United States

HSHS Saint Elizabeth's Hospital

O'Fallon, Illinois, United States

Illinois CancerCare-Ottawa Clinic

Ottawa, Illinois, United States

Illinois CancerCare-Pekin

Pekin, Illinois, United States

OSF Saint Francis Radiation Oncology at Pekin

Pekin, Illinois, United States

Illinois CancerCare-Peoria

Peoria, Illinois, United States

OSF Saint Francis Radiation Oncology at Peoria Cancer Center

Peoria, Illinois, United States

Methodist Medical Center of Illinois

Peoria, Illinois, United States

OSF Saint Francis Medical Center

Peoria, Illinois, United States

Illinois CancerCare-Peru

Peru, Illinois, United States

Valley Radiation Oncology

Peru, Illinois, United States

Illinois CancerCare-Princeton

Princeton, Illinois, United States

UW Health Carbone Cancer Center Rockford

Rockford, Illinois, United States

Southern Illinois University School of Medicine

Springfield, Illinois, United States

Springfield Clinic

Springfield, Illinois, United States

Springfield Memorial Hospital

Springfield, Illinois, United States

Southwest Illinois Health Services LLP

Swansea, Illinois, United States

Carle Cancer Center

Urbana, Illinois, United States

The Carle Foundation Hospital

Urbana, Illinois, United States

Illinois CancerCare - Washington

Washington, Illinois, United States

Reid Health

Richmond, Indiana, United States

Saint Anthony Regional Hospital

Carroll, Iowa, United States

Mercy Cancer Center-West Lakes

Clive, Iowa, United States

UI Health Care Mission Cancer and Blood - West Des Moines Clinic

Clive, Iowa, United States

Alegent Health Mercy Hospital

Council Bluffs, Iowa, United States

Greater Regional Medical Center

Creston, Iowa, United States

Iowa Methodist Medical Center