Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
Launched by ALLIANCE FOR CLINICAL TRIALS IN ONCOLOGY · Jul 25, 2018
Trial Information
Current as of June 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is looking at how well two chemotherapy drugs, gemcitabine and cisplatin, work for treating patients with a type of bladder cancer called muscle-invasive urothelial carcinoma. The goal is to see if these drugs can help shrink the tumors without needing to remove the bladder surgically. This study is currently recruiting participants who are between the ages of 65 and 74, and they need to have a specific type of bladder cancer that hasn't spread to other parts of the body.
To join the trial, patients must meet certain health criteria, like having had a recent bladder cancer diagnosis and no prior treatments that could interfere with the study. Participants will receive the chemotherapy and will be monitored closely for any side effects or changes in their condition. It's important for potential participants to know that the study involves tests on their tumor samples to look for specific genetic changes that might affect treatment. Overall, this trial aims to find better treatment options for patients with this challenging form of cancer.
Gender
ALL
Eligibility criteria
- 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
About Alliance For Clinical Trials In Oncology
The Alliance for Clinical Trials in Oncology is a prominent cooperative group dedicated to conducting high-quality, innovative clinical research aimed at improving cancer treatment and patient outcomes. Comprising a diverse network of institutions and investigators, the Alliance focuses on developing and implementing clinical trials that evaluate new therapies, treatment combinations, and prevention strategies across various cancer types. By fostering collaboration among oncologists, researchers, and healthcare professionals, the Alliance aims to accelerate the translation of scientific discoveries into effective clinical practices, ultimately enhancing the standard of care for cancer patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
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Lansing, Michigan, United States
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Pontiac, Michigan, United States
Silverdale, Washington, United States
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Walnut Creek, California, United States
Saginaw, Michigan, United States
Tawas City, Michigan, United States
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Grosse Pointe Woods, Michigan, United States
Grosse Pointe Woods, Michigan, United States
Macomb, Michigan, United States
Warren, Michigan, United States
Metairie, Louisiana, United States
Flint, Michigan, United States
Warren, Michigan, United States
Kearney, Nebraska, United States
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Macomb, Michigan, United States
Warren, Michigan, United States
Havre, Montana, United States
Grosse Pointe Woods, Michigan, United States
Rochester Hills, Michigan, United States
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Des Moines, Iowa, United States
Des Moines, Iowa, United States
East China, Michigan, United States
Macomb Township, Michigan, United States
Macomb Township, Michigan, United States
Denver, Colorado, United States
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Kearney, Nebraska, United States
Patients applied
Trial Officials
Gopa Iyer, MD
Study Chair
Memorial Sloan Kettering Cancer Center
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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