Bladder Cancer

EA8212 / BRIDGE



A Randomized Phase III Trial of Intravesical BCG versus Intravesical Docetaxel and Gemcitabine Treatment in BCG Naive Non-Muscle Invasive Bladder Cancer (The BRIDGE Trial)

STATUS: Active


This phase III trial compares the effect of chemotherapy drugs (gemcitabine in combination with docetaxel) to the usual treatment with bacillus Calmette-Guerin (BCG) in patients with non-muscle invasive bladder cancer who have not previously received BCG (BCG naive). Gemcitabine is a chemotherapy drug that blocks the cells from making DNA and may kill cancer cells. Docetaxel is in a class of medications called taxanes. It stops cancer cells from growing and dividing and may kill them. BCG is a weakened form of the bacterium Mycobacterium bovis (bacillus Calmette-Guรฉrin) that does not cause disease. BCG is used in a solution to stimulate the immune system in the treatment of bladder cancer by administering it into the bladder (intravesical). Chemotherapy with intravesical gemcitabine and docetaxel may be similarly effective and not be inferior to the usual treatment with intravesical BCG for shrinking tumor and preventing cancer from coming back (recurrence) in patients with BCG naive non-muscle invasive bladder cancer.
  • Patient must be >= 18 years of age.

  • Patient must have histologically confirmed high-grade non-muscle invasive urothelial carcinoma of the bladder (HGTa, HGT1, CIS, HGTa + CIS, or HGT1 + CIS stage) on transurethral resection of bladder tumor (TURBT) obtained within 90 days prior to randomization.

  • Patient must have all visible papillary tumor resected by the treating urologist at the site registering the patient to this protocol prior to randomization. If the treating urologist did not perform the TURBT, the treating urologist must perform a cystoscopy within 28 days prior to randomization to confirm the absence of visible papillary disease.

  • Patients with high grade T1 disease must have undergone a restaging TURBT within 90 days prior to Step 1 randomization.

  • Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.

  • Patient must have ECOG Performance Status 0-2.

  • Patient may have received prior systemic gemcitabine or docetaxel use if it was for a non-bladder malignancy.

  • Patient must have the ability to understand and the willingness to sign a written informed consent document. Patients with impaired decision-making capacity (IDMC) who have a legally authorized representative (LAR) or caregiver and/or family member available will also be considered eligible.

  • Leukocytes >= 3,000/mcL (obtained =< 28 days prior to randomization).

  • Absolute neutrophil count (ANC) >= 1,500/mcL (obtained =< 28 days prior to randomization).

  • Platelets >= 70,000/mcL (obtained =< 28 days prior to randomization).

  • Total bilirubin =< 1.5 x institutional upper limit of normal (ULN) (obtained =< 28 days prior to randomization).

  • Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase [SGOT ])/alanine aminotransferase (ALT) (serum glutamic-pyruvic transaminase [SGPT]) =< 3.0 x institutional ULN (obtained =< 28 days prior to randomization).

  • Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months of randomization are eligible for this trial.

  • For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.

  • Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.

  • Patients with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, patients should be class 2B or better.

  • Patients will be enrolled in the QOL study if the patient can read and understand English, Spanish, or Chinese (simplified characters). * NOTE: Sites cannot translate the associated QOL forms.

  • Patient must not have any prior or current history of muscle-invasive (i.e., T2, T3, T4), locally advanced unresectable, or metastatic urothelial carcinoma as assessed on radiographic imaging obtained within 90 days prior to randomization. The radiographic imaging includes a computed tomography (CT) scan OR magnetic resonance imaging (MRI) of the abdomen/pelvis with intravenous contrast. * Note: If a patientโ€™s renal function does not permit the administration of intravenous contrast, either a CT scan or MRI of the abdomen/pelvis without intravenous contrast is acceptable. ** Note: Patients with a history of non-invasive (Ta, Tis) upper tract urothelial carcinoma that has been definitively treated with at least one post-treatment disease assessment (i.e., either cytology, biopsy, or imaging) that demonstrates no evidence of residual disease are eligible.

  • Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.

  • Patient must not have pure squamous cell carcinoma or adenocarcinoma.

  • Patient must not have any component of neuroendocrine carcinoma (i.e., small cell or large cell).

  • Patient must not have any component of sarcomatoid, micropapillary, or plasmacytoid variant histology.

  • Patient must not be pregnant or breast-feeding due to the potential harm to an unborn fetus and possible risk for adverse events in nursing infants with the treatment regimens being used. * All patients of childbearing potential must have a blood test or urine study within 14 days prior to randomization to rule out pregnancy. * A patient of childbearing potential is defined as anyone, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has achieved menarche at some point, 2) has not undergone a hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal (amenorrhea following cancer therapy does not rule out childbearing potential) for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months).

  • Patient must not expect to conceive or father children by using an accepted and effective method(s) of contraception or by abstaining from sexual intercourse for the duration of their participation in the study. In addition, patients on Arm A must continue contraception measures for six months after the last dose of GEMDOCE for patients of child-bearing potential and continue for three month after the last dose of GEMDOC for male patients with partners of child-bearing potential. All patients must not breastfeed during their time on protocol treatment.

  • Patient must not have a history of severe hypersensitivity reactions to docetaxel or drugs formulated with polysorbate 80.

United States
AK
Fairbanks
Fairbanks Memorial Hospital
Contact: Site Public Contact
Email: Veronica.Stevenson@foundationhealth.org

AL
Birmingham
University of Alabama at Birmingham Cancer Center
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Email: tmyrick@uab.edu

AR
Ft. Smith
Mercy Hospital Fort Smith
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Little Rock
CARTI Cancer Center
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Email: Research@CARTI.com

AZ
Gilbert
Banner MD Anderson Cancer Center
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CA
La Jolla
UC San Diego Moores Cancer Center
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Email: cancercto@ucsd.edu

Los Angeles
Los Angeles County-USC Medical Center
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USC / Norris Comprehensive Cancer Center
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CO
Aurora
Rocky Mountain Cancer Centers-Aurora
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Email: info@westernstatesncorp.org

UCHealth University of Colorado Hospital
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Boulder
Boulder Community Foothills Hospital
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Boulder
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Email: info@westernstatesncorp.org

Centennial
Rocky Mountain Cancer Centers - Centennial
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Email: info@westernstatesncorp.org

Denver
Colorado Blood Cancer Institute
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Email: info@westernstatesncorp.org

Presbyterian - Saint Lukes Medical Center - Health One
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Midtown
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers-Rose
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Email: info@westernstatesncorp.org

Rose Medical Center
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Email: ccrp@co-cancerresearch.org

The Women's Imaging Center
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Email: info@westernstatesncorp.org

Englewood
Mountain Blue Cancer Care Center - Swedish
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Email: info@westernstatesncorp.org

Rocky Mountain Cancer Centers - Swedish
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Email: info@westernstatesncorp.org

Swedish Medical Center
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Email: info@westernstatesncorp.org

The Melanoma and Skin Cancer Institute
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Email: ryan.weight@theskincancerinstitute.com

Lakewood
Rocky Mountain Cancer Centers-Lakewood
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Email: info@westernstatesncorp.org

Littleton
Rocky Mountain Cancer Centers-Littleton
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Email: info@westernstatesncorp.org

Lone Tree
Rocky Mountain Cancer Centers-Sky Ridge
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Email: info@westernstatesncorp.org

Thornton
Rocky Mountain Cancer Centers-Thornton
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Email: info@westernstatesncorp.org

DC
Washington
George Washington University Medical Center
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MedStar Georgetown University Hospital
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MedStar Washington Hospital Center
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Sibley Memorial Hospital
Contact: Site Public Contact
Email: jquiver1@jhmi.edu

FL
Gainesville
University of Florida Health Science Center - Gainesville
Contact: Site Public Contact
Email: cancer-center@ufl.edu

IA
Ames
Mary Greeley Medical Center
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McFarland Clinic - Ames
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Email: ksoder@mcfarlandclinic.com

Boone
McFarland Clinic - Boone
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Fort Dodge
McFarland Clinic - Trinity Cancer Center
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Iowa City
University of Iowa/Holden Comprehensive Cancer Center
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Jefferson
McFarland Clinic - Jefferson
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Marshalltown
McFarland Clinic - Marshalltown
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IL
Alton
Saint Anthony's Health
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Centralia
Saint Mary's Hospital
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Email: ecog.rss@jimmy.harvard.edu

Evanston
NorthShore University HealthSystem-Evanston Hospital
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Glenview
NorthShore University HealthSystem-Glenbrook Hospital
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Highland Park
NorthShore University HealthSystem-Highland Park Hospital
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Maywood
Loyola University Medical Center
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Melrose Park
Marjorie Weinberg Cancer Center at Loyola-Gottlieb
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Mount Vernon
Good Samaritan Regional Health Center
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Skokie
North Shore Medical Center
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Email: ecog.rss@jimmy.harvard.edu

IN
Richmond
Reid Health
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

KS
Garden City
Central Care Cancer Center - Garden City
Contact: Site Public Contact
Email: aroland@kccop.org

Great Bend
Central Care Cancer Center - Great Bend
Contact: Site Public Contact
Email: aroland@kccop.org

KY
Lexington
University of Kentucky/Markey Cancer Center
Contact: Site Public Contact

Paducah
Mercy Health - Paducah Medical Oncology and Hematology
Contact: Site Public Contact
Email: BJWarner@mercy.com

LA
Metairie
LSU Healthcare Network / Metairie Multi-Specialty Clinic
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

New Orleans
Louisiana State University Health Science Center
Contact: Site Public Contact
Email: emede1@lsuhsc.edu

MA
Boston
Brigham and Women's Hospital
Contact: Site Public Contact

MD
Baltimore
Johns Hopkins University/Sidney Kimmel Cancer Center
Contact: Site Public Contact
Email: jhcccro@jhmi.edu

ME
South Portland
Maine Medical Partners Urology
Contact: Site Public Contact
Email: ClinicalResearch@mmc.org

MI
Ann Arbor
University of Michigan Comprehensive Cancer Center
Contact: Site Public Contact

MO
Ballwin
Saint Louis Cancer and Breast Institute-Ballwin
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Bolivar
Central Care Cancer Center - Bolivar
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Email: aroland@kccop.org

Branson
Cox Cancer Center Branson
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Joplin
Freeman Health System
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Email: LJCrockett@freemanhealth.com

Mercy Hospital Joplin
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Email: esmeralda.carrillo@mercy.net

Osage Beach
Lake Regional Hospital
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Email: clinicaltrials@lakeregional.com

Rolla
Delbert Day Cancer Institute at PCRMC
Contact: Site Public Contact
Email: research@phelpshealth.org

Mercy Clinic-Rolla-Cancer and Hematology
Contact: Site Public Contact

Saint Joseph
Heartland Regional Medical Center
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Email: linda.schumacher@mymlc.com

Saint Louis
Mercy Hospital Saint Louis
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Mercy Hospital South
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Email: Danielle.Werle@mercy.net

Saint Louis Cancer and Breast Institute-South City
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Springfield
CoxHealth South Hospital
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Mercy Hospital Springfield
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Washington
Mercy Hospital Washington
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NC
Chapel Hill
UNC Lineberger Comprehensive Cancer Center
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Email: cancerclinicaltrials@med.unc.edu

NH
Lebanon
Dartmouth Hitchcock Medical Center/Dartmouth Cancer Center
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Email: cancer.research.nurse@dartmouth.edu

NJ
Basking Ridge
Memorial Sloan Kettering Basking Ridge
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Hackensack
Hackensack University Medical Center
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Lakewood
Monmouth Medical Center Southern Campus
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Email: mary.danish@rwjbh.org

Livingston
Saint Barnabas Medical Center
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Email: joanne.loeb@rwjbh.org

Long Branch
Monmouth Medical Center
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Email: mary.danish@rwjbh.org

Middletown
Memorial Sloan Kettering Monmouth
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Montvale
Memorial Sloan Kettering Bergen
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New Brunswick
Rutgers Cancer Institute of New Jersey
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Newark
Rutgers New Jersey Medical School
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Somerville
Robert Wood Johnson University Hospital Somerset
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Email: Siby.Varughese@rwjbh.org

Toms River
Community Medical Center
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Email: Lennette.Gonzales@rwjbh.org

NM
Albuquerque
University of New Mexico Cancer Center
Contact: Site Public Contact
Email: HSC-ClinicalTrialInfo@salud.unm.edu

NY
Albany
Albany Medical Center
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Buffalo
Roswell Park Cancer Institute
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Email: askroswell@roswellpark.org

Commack
Memorial Sloan Kettering Commack
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New York
Laura and Isaac Perlmutter Cancer Center at NYU Langone
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Email: CancerTrials@nyulangone.org

Memorial Sloan Kettering Cancer Center
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Mount Sinai Hospital
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Email: CCTO@mssm.edu

Stony Brook
Stony Brook University Medical Center
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Uniondale
Memorial Sloan Kettering Nassau
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West Harrison
Memorial Sloan Kettering Westchester
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OH
Beavercreek
Indu and Raj Soin Medical Center
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Email: clinical.trials@daytonncorp.org

Boardman
Saint Elizabeth Boardman Hospital
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Email: clinical.trials@daytonncorp.org

Centerville
Dayton Physicians LLC-Miami Valley South
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Email: clinical.trials@daytonncorp.org

Cincinnati
Oncology Hematology Care Inc-Kenwood
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Email: clinical.trials@daytonncorp.org

Columbus
Ohio State University Comprehensive Cancer Center
Contact: Site Public Contact
Email: Jamesline@osumc.edu

Dayton
Dayton Physician LLC-Miami Valley Hospital North
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Findlay
Armes Family Cancer Center
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Email: clinical.trials@daytonncorp.org

Blanchard Valley Hospital
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Email: clinical.trials@daytonncorp.org

Orion Cancer Care
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Email: clinical.trials@daytonncorp.org

Franklin
Dayton Physicians LLC-Atrium
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Email: clinical.trials@daytonncorp.org

Greenville
Dayton Physicians LLC-Wayne
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Email: clinical.trials@daytonncorp.org

Wayne Hospital
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Email: clinical.trials@daytonncorp.org

Kettering
Greater Dayton Cancer Center
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Email: clinical.trials@daytonncorp.org

Kettering Medical Center
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Email: clinical.trials@daytonncorp.org

Troy
Dayton Physicians LLC - Troy
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Email: clinical.trials@daytonncorp.org

Warren
Saint Joseph Warren Hospital
Contact: Site Public Contact
Email: clinical.trials@daytonncorp.org

Youngstown
Saint Elizabeth Youngstown Hospital
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Email: clinical.trials@daytonncorp.org

OK
Oklahoma City
Mercy Hospital Oklahoma City
Contact: Site Public Contact

University of Oklahoma Health Sciences Center
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Email: ou-clinical-trials@ouhsc.edu

OR
Portland
Oregon Health and Science University
Contact: Site Public Contact
Email: trials@ohsu.edu

Portland VA Medical Center
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PA
Hershey
Penn State Milton S Hershey Medical Center
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Email: CTO@hmc.psu.edu

Philadelphia
Fox Chase Cancer Center
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Thomas Jefferson University Hospital
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Email: ONCTrialNow@jefferson.edu

University of Pennsylvania/Abramson Cancer Center
Contact: Site Public Contact

Rockledge
Fox Chase Cancer Center-Rockledge
Contact: Site Public Contact
Email: ecog.rss@jimmy.harvard.edu

SC
Anderson
AnMed Health Cancer Center
Contact: Site Public Contact
Email: rhonda.ballew@anmedhealth.org

Charleston
Medical University of South Carolina
Contact: Site Public Contact
Email: hcc-clinical-trials@musc.edu

Ralph H Johnson VA Medical Center
Contact: Site Public Contact
Email: ashley.salvo@va.gov

Florence
MUSC Health Florence Medical Center
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Email: adamslud@musc.edu

Greenville
Prisma Health Greenville Memorial Hospital
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West Columbia
Lexington Medical Center
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Email: LMCIRB@lexhealth.org

TX
Conroe
MD Anderson in The Woodlands
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

Galveston
University of Texas Medical Branch
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Email: clinical.research@utmb.edu

Houston
Baylor College of Medicine/Dan L Duncan Comprehensive Cancer Center
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Email: burton@bcm.edu

Ben Taub General Hospital
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Houston Methodist Hospital
Contact: Site Public Contact

M D Anderson Cancer Center
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Email: askmdanderson@mdanderson.org

MD Anderson West Houston
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

Michael E DeBakey VA Medical Center
Contact: Site Public Contact

League City
MD Anderson League City
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

UTMB Cancer Center at Victory Lakes
Contact: Site Public Contact

Sugar Land
MD Anderson in Sugar Land
Contact: Site Public Contact
Email: askmdanderson@mdanderson.org

WI
Madison
University of Wisconsin Carbone Cancer Center
Contact: Site Public Contact

Milwaukee
Medical College of Wisconsin
Contact: Site Public Contact

WV
Morgantown
West Virginia University Healthcare
Contact: Site Public Contact
Email: cancertrialsinfo@hsc.wvu.edu

WY
Cheyenne
Cheyenne Regional Medical Center-West
Contact: Site Public Contact
Email: ccrp@co-cancerresearch.org

PRIMARY OBJECTIVE:
I. To determine the event free survival (EFS) of Bacillus Calmette-Guerin (BCG)- naive high grade non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical BCG versus (vs) gemcitabine hydrochloride (gemcitabine) and docetaxel (GEMDOCE).

SECONDARY OBJECTIVES:
I. To compare changes in cancer-specific and bladder cancer-specific quality of life (QOL) from baseline to treatment between BCG-naive high grade NMIBC patients receiving BCG and GEMDOCE.
II. To determine the cystectomy free survival (CFS) of BCG-naive high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
III. To determine the progression free survival (PFS) of BCG-naive high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
IV. To determine the safety and toxicity of BCG-naive high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A:
INDUCTION: Patients receive gemcitabine hydrochloride intravesically (IVES) and docetaxel IVES once a week (QW) for 6 consecutive weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients with complete response (CR) or resected low grade noninvasive bladder cancer (LgTa) after induction therapy receive gemcitabine hydrochloride IVES and docetaxel IVES monthly for up to 2 years in the absence of disease progression or unacceptable toxicity.

ARM B:
INDUCTION: Patients receive BCG IVES QW for 6 weeks in the absence of disease progression or unacceptable toxicity.

MAINTENANCE: Patients with a CR or LgTa after induction therapy receive BCG IVES QW for 3 consecutive weeks at months 3, 6, 12, 18, 24, 30, and 36 after the start of induction treatment in the absence of disease progression or unacceptable toxicity.

All patients also undergo computed tomography (CT) or magnetic resonance imaging (MRI) scan during screening.

After completion of study treatment, patients are followed up every 6 months for 5 years from the date of randomization.

Interactive content above is from the official study record on the National Cancer Institute website, cancer.gov.


The ECOG-ACRIN Cancer Research Group designed this trial and is conducting it with funding from the National Cancer Institute through its National Clinical Trials Network.


EA8212 / BRIDGE Home Page
ECOG-ACRIN Cancer Research Group