Bladder Cancer Clinical Trial
Intravesical BCG vs GEMDOCE in NMIBC
Summary
The study hypothesis is that BCG naïve non-muscle invasive bladder cancer (NMIBC) patients treated with intravesical Gemcitabine + Docetaxel (GEMDOCE) will result in a non-inferior event-free survival (EFS) compared to standard treatment with intravesical BCG. The purpose of this study is to test whether Gemcitabine + Docetaxel is a better or worse treatment than the usual BCG therapy approach. The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE.
Full Description
The primary objective of this study is to determine the event free survival (EFS) of BCG-naïve high grade non-muscle invasive bladder cancer patients treated with intravesical BCG vs Gemcitabine + Docetaxel. Secondary objectives are as follows: to compare changes in cancer-specific and bladder cancer-specific QOL from baseline to treatment between BCG-naïve high grade NMIBC patients receiving BCG and GEMDOCE, to determine the cystectomy free survival (CFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, to determine the progression free survival (PFS) of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE, and to determine the safety and toxicity of BCG-naïve high grade NMIBC patients treated with intravesical BCG vs GEMDOCE
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.
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There are 103 Locations for this study
Birmingham Alabama, 35233, United States More Info
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Fairbanks Alaska, 99701, United States More Info
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Gilbert Arizona, 85234, United States More Info
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Fort Smith Arkansas, 72903, United States More Info
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Aurora Colorado, 80012, United States More Info
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Aurora Colorado, 80045, United States More Info
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Boulder Colorado, 80303, United States More Info
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Boulder Colorado, 80304, United States More Info
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Centennial Colorado, 80112, United States More Info
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Denver Colorado, 80209, United States More Info
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Denver Colorado, 80218, United States More Info
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Denver Colorado, 80218, United States More Info
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Denver Colorado, 80218, United States More Info
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Denver Colorado, 80220, United States More Info
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Denver Colorado, 80220, United States More Info
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Englewood Colorado, 80113, United States More Info
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Englewood Colorado, 80113, United States More Info
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Englewood Colorado, 80113, United States More Info
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Englewood Colorado, 80113, United States More Info
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Lakewood Colorado, 80228, United States More Info
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Littleton Colorado, 80120, United States More Info
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Lone Tree Colorado, 80124, United States More Info
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Thornton Colorado, 80260, United States More Info
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Washington District of Columbia, 20007, United States More Info
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Washington District of Columbia, 20010, United States More Info
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Washington District of Columbia, 20016, United States More Info
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Washington District of Columbia, 20037, United States More Info
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Gainesville Florida, 32610, United States More Info
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Alton Illinois, 62002, United States More Info
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Centralia Illinois, 62801, United States More Info
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Evanston Illinois, 60201, United States More Info
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Glenview Illinois, 60026, United States More Info
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Highland Park Illinois, 60035, United States More Info
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Mount Vernon Illinois, 62864, United States More Info
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Skokie Illinois, 60076, United States More Info
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Ames Iowa, 50010, United States
Ames Iowa, 50010, United States
Boone Iowa, 50036, United States
Fort Dodge Iowa, 50501, United States
Jefferson Iowa, 50129, United States
Marshalltown Iowa, 50158, United States
Garden City Kansas, 67846, United States More Info
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Great Bend Kansas, 67530, United States More Info
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Lexington Kentucky, 40536, United States More Info
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Paducah Kentucky, 42003, United States More Info
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Metairie Louisiana, 70006, United States More Info
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New Orleans Louisiana, 70112, United States More Info
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Baltimore Maryland, 21287, United States More Info
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Boston Massachusetts, 02115, United States More Info
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Ann Arbor Michigan, 48109, United States More Info
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Ballwin Missouri, 63011, United States More Info
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Bolivar Missouri, 65613, United States More Info
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Branson Missouri, 65616, United States More Info
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Joplin Missouri, 64804, United States More Info
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Joplin Missouri, 64804, United States More Info
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Rolla Missouri, 65401, United States More Info
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Rolla Missouri, 65401, United States More Info
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Saint Joseph Missouri, 64506, United States More Info
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Saint Louis Missouri, 63109, United States More Info
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Saint Louis Missouri, 63128, United States More Info
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Saint Louis Missouri, 63141, United States More Info
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Springfield Missouri, 65804, United States More Info
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Springfield Missouri, 65807, United States More Info
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Washington Missouri, 63090, United States More Info
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Basking Ridge New Jersey, 07920, United States More Info
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Hackensack New Jersey, 07601, United States More Info
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Middletown New Jersey, 07748, United States More Info
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Montvale New Jersey, 07645, United States More Info
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Albuquerque New Mexico, 87102, United States More Info
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Albany New York, 12208, United States More Info
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Buffalo New York, 14263, United States More Info
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Commack New York, 11725, United States More Info
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Harrison New York, 10604, United States More Info
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New York New York, 10065, United States More Info
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Stony Brook New York, 11794, United States More Info
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Uniondale New York, 11553, United States More Info
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Beavercreek Ohio, 45431, United States More Info
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Boardman Ohio, 44512, United States More Info
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Centerville Ohio, 45459, United States More Info
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Cincinnati Ohio, 45236, United States More Info
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Columbus Ohio, 43210, United States More Info
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Dayton Ohio, 45415, United States More Info
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Findlay Ohio, 45840, United States More Info
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Findlay Ohio, 45840, United States More Info
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Findlay Ohio, 45840, United States More Info
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Franklin Ohio, 45005, United States More Info
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Greenville Ohio, 45331, United States More Info
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Greenville Ohio, 45331, United States More Info
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Kettering Ohio, 45409, United States More Info
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Kettering Ohio, 45429, United States More Info
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Troy Ohio, 45373, United States More Info
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Warren Ohio, 44484, United States More Info
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Youngstown Ohio, 44501, United States More Info
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Oklahoma City Oklahoma, 73104, United States More Info
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Oklahoma City Oklahoma, 73120, United States More Info
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Portland Oregon, 97239, United States More Info
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Hershey Pennsylvania, 17033, United States More Info
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Philadelphia Pennsylvania, 19111, United States More Info
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Rockledge Pennsylvania, 19046, United States More Info
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Anderson South Carolina, 29621, United States More Info
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Charleston South Carolina, 29401, United States More Info
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Charleston South Carolina, 29425, United States More Info
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Greenville South Carolina, 29605, United States More Info
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West Columbia South Carolina, 29169, United States
Galveston Texas, 77555, United States More Info
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Houston Texas, 77030, United States More Info
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League City Texas, 77573, United States More Info
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Port Townsend Washington, 98368, United States More Info
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Seattle Washington, 98109, United States More Info
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Seattle Washington, 98109, United States More Info
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Seattle Washington, 98195, United States More Info
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Morgantown West Virginia, 26506, United States More Info
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Madison Wisconsin, 53792, United States More Info
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Milwaukee Wisconsin, 53226, United States More Info
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Cheyenne Wyoming, 82001, United States More Info
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