Phase I

Study Title: Ethacrynic Acid Elimination in Nonmuscle Invasive Bladder Cancer Patients Undergoing Transurethral Resection

Study Type: Phase I/interventional/single-group assignment

Study Sponsor and Collaborators: University of Kansas Medical Center

Purpose: To provide quantitative characterization of the renal elimination of ethacrynic acid and metabolites in patients with nonmuscle invasive bladder cancer at the time of transurethral resection of bladder tumor

Primary Outcome Measures: (1) Urine concentration: ethacrynic acid and its conjugates [time frames: baseline at 30 minutes before surgery; during surgery; 2 hours after surgery; and 4 hours after surgery]; (2) Excretion rates: acid and its conjugates [time frames: baseline at 30 minutes before surgery; during surgery; 2 hours after surgery; and 4 hours after surgery]

Principal Investigator: Eugene K. Lee, MD, University of Kansas Cancer Center; (913) 588-7564, elee@kumc.edu

ClinicalTrials.gov Identifier: NCT02852564

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Study Title: A Phase I/1b Study of Enzalutamide in Combination With Gemcitabine and Cisplatin in Bladder Cancer

Study Type: Phase I/interventional/single-group assignment

Study Sponsor and Collaborators: H. Lee Moffitt Cancer Center and Research Institute

Purpose: To determine the dose of enzalutamide that can be safely given in combination with gemcitabine and cisplatin in patients with advanced bladder cancer

Primary Outcome Measures: Maximum tolerated dose [time frame: up to 6 months]

Principal Investigator: Jingsong Zhang, MD, PhD, H. Lee Moffitt; (813) 745-6454, jingsong.zhang@moffitt.org

ClinicalTrials.gov Identifier: NCT02300610

Phase II

Study Title: Phase II Trial of Estrogen Receptor–Targeted Treatment of Nonmuscle Invasive Bladder Cancer With Tamoxifen

Study Type: Phase II/interventional/single-group assignment

Study Sponsor and Collaborators: Baylor College of Medicine, National Cancer Institute

Purpose: To evaluate the treatment of tamoxifen in low/intermediate-risk bladder tumors

Primary Outcome Measures: Evaluation of the efficacy for treatment of low/intermediate-risk bladder tumors, assessing for the clinical response of the marker lesion [time frame: 4 years]

Principal Investigator: Guilherme Godoy, MD, Baylor College of Medicine; (713) 798-4001, godoy@bcm.edu

ClinicalTrials.gov Identifier: NCT02197897

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Study Title: A Randomized, Prospective, Phase II Study to Determine the Efficacy of Bacillus Calmette-Guérin (BCG) Given in Combination With PANVAC vs BCG Given Alone in Adults With High-Grade Nonmuscle Invasive Bladder Cancer Who Failed at Least One Induction Course of BCG

Study Type: Phase II/interventional/parallel assignment

Study Sponsor and Collaborators: National Cancer Institute, Rutgers Cancer Institute of New Jersey

Purpose: To test PANVAC on people with high-grade nonmuscle invasive bladder cancer. Investigators will give it to people who have not responded to the usual treatment BCG over several weeks to determine whether PANVAC plus BCG is more effective than BCG alone.

Primary Outcome Measures: Improvement in disease-free survival with BCG and PANVAC compared with BCG alone [time frame: 4–5 years]

Principal Investigator: Piyush K. Agarwal, MD, National Cancer Institute; (301) 496-6353, agarwalpk2@mail.nih.gov

ClinicalTrials.gov Identifier: NCT02015104

Phase III

Study Title: A Prospective, Open-Label Randomized Clinical Trial of a Single Bladder Instillation of Mitomycin C vs Gemcitabine vs No Additional Treatment Immediately After Transurethral Resection of Bladder Tumor

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: Spectrum Health Hospitals

Purpose: To compare the efficacy of mitomycin C vs gemcitabine vs no adjuvant treatment as a single intraoperative instillation in preventing recurrence of bladder cancer

Primary Outcome Measures: Efficacy measured by the number of patients with grades 3–5 adverse events, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.03 [time frame: 2 years]

Principal Investigator: Richard J. Kahnoski, MD, Spectrum Health Hospitals; contact Susan M. Engerman, BSN, (616) 267-8406, susan.engerman@spectrumhealth.org

ClinicalTrials.gov Identifier: NCT02695771

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Study Title: Prevention of Parastomal Hernia Following Radical Cystectomy and Ileal Conduit Using Biologic Mesh: Randomized Clinical Trial

Study Type: Phase III/interventional/parallel assignment

Study Sponsor and Collaborators: University of Southern California, National Cancer Institute, Musculoskeletal Transplant Foundation

Purpose: To study how well biologic mesh works in preventing parastomal hernia in patients with bladder cancer who are undergoing radical cystectomy and ileal conduit ­diversion

Primary Outcome Measures: Rate of development of a clinical or radiologic parastomal hernia [time frame: up to 2 years]

Principal Investigator: Hooman Djaladat, MD, MS, University of Southern California; contact Ileana Aldana, (323) 865-0702, ileana.aldana@med.usc.edu

ClinicalTrials.gov Identifier: NCT02439060 ■

Editor’s Note: The clinical trials presented here do not represent all the trials listed on ClinicalTrials.gov. For the complete list, go to ClinicalTrials.gov.