Intravesical BCG vs GEMDOCE in NMIBC (BRIDGE)
Non-muscle-invasive Bladder Cancer
About this trial
This is an interventional treatment trial for Non-muscle-invasive Bladder Cancer
Eligibility Criteria
Inclusion Criteria:
- 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 as outlined in Section 3.1.3, the treating urologist must perform a cystoscopy within 28 days prior to randomization to confirm the absence of visible papillary disease.
- Patient must have not received prior intravesical therapy for bladder cancer, with the exception of perioperative chemotherapy at the time of TURBT.
- Patients with high grade T1 disease must have undergone a restaging TURBT within 90 days prior to Step 1 randomization.
NOTE: Patients with high grade T1 disease who undergo a restaging TURBT that shows no residual cancer in the restaging TURBT specimen are eligible.
- 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.
- 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.
- Patient must have adequate organ and marrow function as defined below (these labs must be obtained ≤ 28 days prior to randomization):
Leukocytes ≥ 3,000/mcL Leukocytes:__________ Date of Test:__________ Absolute neutrophil count (ANC) ≥ 1,500/mcL ANC:__________ Date of Test:__________ Platelets ≥ 70,000/mcL Platelets:__________ Date of Test:__________ Total Bilirubin ≤ institutional upper limit of normal (ULN) Total Bilirubin:__________ Institutional ULN:_________ Date of Test:__________ AST(SGOT)/ALT(SGPT) ≤ 3.0 × institutional ULN AST:_______ Institutional ULN:_________ Date of Test:_______ ALT: _______Institutional ULN:_________
- 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.
Exclusion Criteria:
- 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 CT Scan OR MRI of the abdomen/pelvis with intravenous contrast.
NOTE: If a patient'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 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 of child bearing potential? ______ (Yes or No) Date of blood test or urine study: ___________
- 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.
Sites / Locations
- University of Alabama at Birmingham Cancer CenterRecruiting
- Fairbanks Memorial HospitalRecruiting
- Banner MD Anderson Cancer CenterRecruiting
- Mercy Hospital Fort SmithRecruiting
- CARTI Cancer CenterRecruiting
- UC San Diego Moores Cancer Center
- Rocky Mountain Cancer Centers-AuroraRecruiting
- UCHealth University of Colorado HospitalRecruiting
- Boulder Community Foothills HospitalRecruiting
- Rocky Mountain Cancer Centers-BoulderRecruiting
- Rocky Mountain Cancer Centers - CentennialRecruiting
- The Women's Imaging CenterRecruiting
- Colorado Blood Cancer InstituteRecruiting
- Presbyterian - Saint Lukes Medical Center - Health OneRecruiting
- Rocky Mountain Cancer Centers-MidtownRecruiting
- Rocky Mountain Cancer Centers-RoseRecruiting
- Rose Medical CenterRecruiting
- Mountain Blue Cancer Care Center - SwedishRecruiting
- Rocky Mountain Cancer Centers - SwedishRecruiting
- Swedish Medical CenterRecruiting
- The Melanoma and Skin Cancer InstituteRecruiting
- Rocky Mountain Cancer Centers-LakewoodRecruiting
- Rocky Mountain Cancer Centers-LittletonRecruiting
- Rocky Mountain Cancer Centers-Sky RidgeRecruiting
- Rocky Mountain Cancer Centers-ThorntonRecruiting
- MedStar Georgetown University HospitalRecruiting
- MedStar Washington Hospital CenterRecruiting
- Sibley Memorial HospitalRecruiting
- George Washington University Medical CenterRecruiting
- University of Florida Health Science Center - GainesvilleRecruiting
- Saint Anthony's HealthRecruiting
- Saint Mary's HospitalRecruiting
- NorthShore University HealthSystem-Evanston HospitalRecruiting
- NorthShore University HealthSystem-Glenbrook HospitalRecruiting
- NorthShore University HealthSystem-Highland Park HospitalRecruiting
- Loyola University Medical CenterRecruiting
- Marjorie Weinberg Cancer Center at Loyola-GottliebRecruiting
- Good Samaritan Regional Health CenterRecruiting
- North Shore Medical CenterRecruiting
- Reid HealthRecruiting
- Mary Greeley Medical Center
- McFarland Clinic - Ames
- McFarland Clinic - Boone
- McFarland Clinic - Trinity Cancer Center
- University of Iowa/Holden Comprehensive Cancer CenterRecruiting
- McFarland Clinic - Jefferson
- McFarland Clinic - Marshalltown
- Central Care Cancer Center - Garden CityRecruiting
- Central Care Cancer Center - Great BendRecruiting
- University of Kentucky/Markey Cancer CenterRecruiting
- Mercy Health - Paducah Medical Oncology and HematologyRecruiting
- LSU Healthcare Network / Metairie Multi-Specialty ClinicRecruiting
- Louisiana State University Health Science CenterRecruiting
- Maine Medical Partners UrologyRecruiting
- Johns Hopkins University/Sidney Kimmel Cancer CenterRecruiting
- Brigham and Women's HospitalRecruiting
- University of Michigan Comprehensive Cancer CenterRecruiting
- Saint Louis Cancer and Breast Institute-BallwinRecruiting
- Central Care Cancer Center - BolivarRecruiting
- Cox Cancer Center BransonRecruiting
- Freeman Health SystemRecruiting
- Mercy Hospital JoplinRecruiting
- Lake Regional HospitalRecruiting
- Delbert Day Cancer Institute at PCRMCRecruiting
- Mercy Clinic-Rolla-Cancer and HematologyRecruiting
- Heartland Regional Medical CenterRecruiting
- Saint Louis Cancer and Breast Institute-South CityRecruiting
- Mercy Hospital SouthRecruiting
- Mercy Hospital Saint LouisRecruiting
- Mercy Hospital SpringfieldRecruiting
- CoxHealth South HospitalRecruiting
- Mercy Hospital WashingtonRecruiting
- Dartmouth Hitchcock Medical Center/Dartmouth Cancer CenterRecruiting
- Memorial Sloan Kettering Basking RidgeRecruiting
- Hackensack University Medical CenterRecruiting
- Monmouth Medical Center Southern CampusRecruiting
- Saint Barnabas Medical CenterRecruiting
- Monmouth Medical CenterRecruiting
- Memorial Sloan Kettering MonmouthRecruiting
- Memorial Sloan Kettering BergenRecruiting
- Rutgers Cancer Institute of New JerseyRecruiting
- Rutgers New Jersey Medical SchoolRecruiting
- Robert Wood Johnson University Hospital SomersetRecruiting
- Community Medical CenterRecruiting
- University of New Mexico Cancer CenterRecruiting
- Albany Medical CenterRecruiting
- Roswell Park Cancer InstituteRecruiting
- Memorial Sloan Kettering CommackRecruiting
- Memorial Sloan Kettering WestchesterRecruiting
- Laura and Isaac Perlmutter Cancer Center at NYU LangoneRecruiting
- Memorial Sloan Kettering Cancer CenterRecruiting
- Stony Brook University Medical CenterRecruiting
- Memorial Sloan Kettering NassauRecruiting
- Indu and Raj Soin Medical CenterRecruiting
- Saint Elizabeth Boardman HospitalRecruiting
- Dayton Physicians LLC-Miami Valley SouthRecruiting
- Oncology Hematology Care Inc-KenwoodRecruiting
- Ohio State University Comprehensive Cancer CenterRecruiting
- Dayton Physician LLC-Miami Valley Hospital NorthRecruiting
- Armes Family Cancer CenterRecruiting
- Blanchard Valley HospitalRecruiting
- Orion Cancer CareRecruiting
- Dayton Physicians LLC-AtriumRecruiting
- Dayton Physicians LLC-WayneRecruiting
- Wayne HospitalRecruiting
- Greater Dayton Cancer CenterRecruiting
- Kettering Medical CenterRecruiting
- Dayton Physicians LLC - TroyRecruiting
- Saint Joseph Warren HospitalRecruiting
- Saint Elizabeth Youngstown HospitalRecruiting
- University of Oklahoma Health Sciences CenterRecruiting
- Mercy Hospital Oklahoma CityRecruiting
- Oregon Health and Science UniversityRecruiting
- Portland VA Medical CenterRecruiting
- Penn State Milton S Hershey Medical CenterRecruiting
- University of Pennsylvania/Abramson Cancer CenterRecruiting
- Fox Chase Cancer CenterRecruiting
- Fox Chase Cancer Center-RockledgeRecruiting
- AnMed Health Cancer CenterRecruiting
- Ralph H Johnson VA Medical CenterRecruiting
- Medical University of South CarolinaRecruiting
- MUSC Health Florence Medical CenterRecruiting
- Prisma Health Greenville Memorial HospitalRecruiting
- Lexington Medical Center
- MD Anderson in The WoodlandsRecruiting
- University of Texas Medical BranchRecruiting
- Baylor College of Medicine/Dan L Duncan Comprehensive Cancer CenterRecruiting
- Ben Taub General HospitalRecruiting
- Houston Methodist HospitalRecruiting
- M D Anderson Cancer CenterRecruiting
- Michael E DeBakey VA Medical CenterRecruiting
- MD Anderson West HoustonRecruiting
- MD Anderson League CityRecruiting
- UTMB Cancer Center at Victory LakesRecruiting
- MD Anderson in Sugar LandRecruiting
- Jefferson HealthcareRecruiting
- FHCC South Lake UnionRecruiting
- Fred Hutchinson Cancer Research CenterRecruiting
- University of Washington Medical Center - MontlakeRecruiting
- West Virginia University HealthcareRecruiting
- University of Wisconsin Carbone Cancer CenterRecruiting
- Medical College of WisconsinRecruiting
- Cheyenne Regional Medical Center-WestRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Arm A
Arm B
Gemcitabine + Docetaxel
BCG