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Gemcitabine and Cisplatin Wit...

Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

Last Updated: 2025-12-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

271 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-10

Study Completion Date

2029-02-01

Brief Summary

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This phase II trial studies how well gemcitabine hydrochloride and cisplatin work in treating participants with invasive bladder urothelial cancer. Drugs used in chemotherapy, such as gemcitabine hydrochloride and cisplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

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Detailed Description

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PRIMARY OBJECTIVES:

I. To determine the 3-year event free survival, defined as the proportion of patients without invasive or metastatic recurrence following definitive gemcitabine hydrochloride (gemcitabine) and cisplatin (standard or dose-dense) chemotherapy in those patients whose pre-treatment transurethral resection of bladder tumor (TURBT) tumors harbor deleterious DDR gene alterations and who achieve \< cT1 response to chemotherapy.

SECONDARY OBJECTIVES:

I. To determine the clinical response rate (\< cT1) for patients harboring deleterious DDR gene alterations following dose dense gemcitabine and cisplatin.

II. To determine the bladder-intact and overall survival for DDR-altered patients with \< cT1.

III. For DDR gene altered patients who elect radical cystectomy despite \< cT1, to determine the pT0 rate in this patient population.

IV. To determine the pathologic response rate at cystectomy and 3-year recurrence-free and overall survival for patients without DDR mutations who are registered onto this trial.

V. To assess the local treatment burden (Bacillus Calmette-Guerin \[BCG\] therapy, resection of non-invasive disease, checkpoint blockade) over time in the bladder-sparing group.

VI. To determine the bladder-intact disease-free survival in patients who elect to undergo chemoradiation therapy in the DDR mutant group and the DDR wild-type group.

OUTLINE:

Participants receive gemcitabine hydrochloride intravenously (IV) over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim subcutaneously (SC) on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants are then assigned to 1 of 2 arms.

ARM I: Participants with DDR gene alteration and disease stage \< cT1 undergo bladder sparing.

ARM II: Participants with DDR gene alteration and disease stage \>= cT1 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.

After completion of study treatment, participants are followed up for 5 years.

Conditions

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Infiltrating Bladder Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma Stage III Bladder Urothelial Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (gemcitabine, cisplatin, bladder sparing)

Participants receive gemcitabine hydrochloride IV over 30 minutes on day 1, cisplatin IV on days 1 and 2, and pegfilgrastim SC on day 3. Treatment repeats every 14 days for up to 6 courses in the absence of disease progression or unaccepted toxicity. Participants with DDR gene alteration and disease stage \< cT1 undergo bladder sparing.

Group Type EXPERIMENTAL

Gemcitabine Hydrochloride

Intervention Type DRUG

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Pegfilgrastim

Intervention Type BIOLOGICAL

Given SC

Conventional Surgery

Intervention Type PROCEDURE

Undergo bladder sparing

Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)

Group Type EXPERIMENTAL

Gemcitabine Hydrochloride

Intervention Type DRUG

Given IV

Cisplatin

Intervention Type DRUG

Given IV

Pegfilgrastim

Intervention Type BIOLOGICAL

Given SC

Radical Cystectomy

Intervention Type PROCEDURE

Undergo radical cystectomy

Chemoradiotherapy

Intervention Type OTHER

Undergo chemoradiotherapy

Interventions

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Gemcitabine Hydrochloride

Given IV

Intervention Type DRUG

Cisplatin

Given IV

Intervention Type DRUG

Pegfilgrastim

Given SC

Intervention Type BIOLOGICAL

Conventional Surgery

Undergo bladder sparing

Intervention Type PROCEDURE

Radical Cystectomy

Undergo radical cystectomy

Intervention Type PROCEDURE

Chemoradiotherapy

Undergo chemoradiotherapy

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gopa Iyer, MD

Role: STUDY_CHAIR

Memorial Sloan Kettering Cancer Center

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United States

Central Contacts

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Gopa Iyer, MD

Role: CONTACT

[email protected]

646-888-4737

Facility Contacts

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Site Public Contact

Role: primary

[email protected]

720-874-1881

Site Public Contact

Role: primary

800-378-9373

Role: primary

530-749-4400

Site Public Contact

Role: primary

[email protected]

720-874-1881

Site Public Contact

Role: primary

[email protected]

720-874-1881

Role: primary

860-545-5363

Site Public Contact

Role: primary

866-662-5678

Site Public Contact

Role: primary

860-224-5660

Site Public Contact

Role: primary

[email protected]

888-823-5923

Role: primary

217-545-7929

Role: primary

888-446-3729

Site Public Contact

Role: primary

[email protected]

573-334-2230

Site Public Contact

Role: primary

573-882-7440

Site Public Contact

Role: primary

[email protected]

800-600-3606

Role: primary

573-458-6379

Site Public Contact

Role: primary

[email protected]

573-458-7504

Site Public Contact

Role: primary

[email protected]

816-271-7937

Site Public Contact

Role: primary

314-996-5569

Site Public Contact

Role: primary

417-269-4520

Role: primary

314-996-5569

Site Public Contact

Role: primary

[email protected]

800-600-3606

Site Public Contact

Role: primary

314-251-7066

Site Public Contact

Role: primary

314-996-5569

Role: primary

[email protected]

315-464-8230

Site Public Contact

Role: primary

[email protected]

315-464-3603

Site Public Contact

Role: primary

585-275-5830

Site Public Contact

Role: primary

315-464-5476

Role: primary

701-364-6272

Site Public Contact

Role: primary

877-405-6866

Site Public Contact

Role: primary

[email protected]

800-782-8581

Site Public Contact

Role: primary

715-422-7718

Other Identifiers

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NCI-2018-01531

Identifier Type: REGISTRY

Identifier Source: secondary_id

U10CA180821

Identifier Type: NIH

Identifier Source: secondary_id

View Link

A031701

Identifier Type: -

Identifier Source: org_study_id

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Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

Study Results

Basic Information

Brief Summary

Related Clinical Trials

Gemcitabine Hydrochloride and Cisplatin Before Surgery in Treating Patients With Muscle Invasive Bladder Cancer

Study of Gemcitabine and Cisplatin With or Without Cetuximab in Urothelial Cancer

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Gemcitabine Hydrochloride and Cisplatin or High-Dose Methotrexate, Vinblastine, Doxorubicin Hydrochloride, and Cisplatin in Treating Patients With Urothelial Cancer

Cisplatin, Paclitaxel, and Gemcitabine in Treating Patients With Progressive Unresectable Regional or Metastatic Bladder Cancer

Detailed Description

Conditions

Study Design

Study Groups

Arm I (gemcitabine, cisplatin, bladder sparing)

Gemcitabine Hydrochloride

Cisplatin

Pegfilgrastim

Conventional Surgery

Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)

Gemcitabine Hydrochloride

Cisplatin

Pegfilgrastim

Radical Cystectomy

Chemoradiotherapy

Interventions

Gemcitabine Hydrochloride

Cisplatin

Pegfilgrastim

Conventional Surgery

Radical Cystectomy

Chemoradiotherapy

Eligibility Criteria

Inclusion Criteria

Sponsors

National Cancer Institute (NCI)

Alliance for Clinical Trials in Oncology

Responsible Party

Principal Investigators

Gopa Iyer, MD

Locations

Fairbanks Memorial Hospital

CTCA at Western Regional Medical Center

Cancer Center at Saint Joseph's

Mercy Hospital Fort Smith

CHI Saint Vincent Cancer Center Hot Springs

University of Arkansas for Medical Sciences

Mission Hope Medical Oncology - Arroyo Grande

Mercy Cancer Center - Carmichael

Mercy San Juan Medical Center

Mercy Cancer Center - Elk Grove

Cedars Sinai Medical Center

Contra Costa Regional Medical Center

Fremont - Rideout Cancer Center

Mercy Cancer Center

Mercy Cancer Center - Rocklin

Mercy Cancer Center - Sacramento

University of California Davis Comprehensive Cancer Center

Pacific Central Coast Health Center-San Luis Obispo

Mission Hope Medical Oncology - Santa Maria

Saint Joseph's Medical Center

BASS Medical Group - Lennon

Woodland Memorial Hospital

Rocky Mountain Cancer Centers-Aurora

The Medical Center of Aurora

Rocky Mountain Cancer Centers-Boulder

Penrose-Saint Francis Healthcare

Rocky Mountain Cancer Centers-Penrose

Saint Francis Cancer Center

AdventHealth Porter

Presbyterian - Saint Lukes Medical Center - Health One

CommonSpirit Cancer Center Mercy

Mercy Medical Center

Mountain Blue Cancer Care Center - Swedish

Swedish Medical Center

The Melanoma and Skin Cancer Institute

Mountain Blue Cancer Care Center

Banner North Colorado Medical Center

Rocky Mountain Cancer Centers-Lakewood

Saint Anthony Hospital