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

Sponsor
Alliance for Clinical Trials in Oncology (Other)
Overall Status
Recruiting
CT.gov ID
NCT03609216
Collaborator
National Cancer Institute (NCI) (NIH)
271
Enrollment
390
Locations
2
Arms
126.1
Anticipated Duration (Months)
0.7
Patients Per Site
0
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Gemcitabine Hydrochloride
  • Drug: Cisplatin
  • Biological: Pegfilgrastim
  • Procedure: Conventional Surgery
  • Procedure: Radical Cystectomy
  • Other: Chemoradiotherapy
 Phase 2

Detailed Description

PRIMARY OBJECTIVES:
  1. 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:

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

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

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

  4. 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.

  5. 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.

  6. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
271 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
A Phase II Study of Gemcitabine Plus Cisplatin Chemotherapy in Patients With Muscle-invasive Bladder Cancer With Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations
Actual Study Start Date :
Aug 1, 2018
Anticipated Primary Completion Date :
Feb 1, 2027
Anticipated Study Completion Date :
Feb 1, 2029

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Drug: Gemcitabine Hydrochloride
Given IV

Drug: Cisplatin
Given IV

Biological: Pegfilgrastim
Given SC

Procedure: Conventional Surgery
Undergo bladder sparing
Experimental: Arm II (gemcitabine, cisplatin, cystectomy, chemoradiotherapy)

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 or participants without DDR gene alteration undergo radical cystectomy or chemoradiotherapy.

Drug: Gemcitabine Hydrochloride
Given IV

Drug: Cisplatin
Given IV

Biological: Pegfilgrastim
Given SC

Procedure: Radical Cystectomy
Undergo radical cystectomy

Other: Chemoradiotherapy
Undergo chemoradiotherapy

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients who are recurrence-free within the DDR mutated group who undergo the bladder sparing approach [At 3 years]

    Will use Kaplan Meier survival analysis to estimate the proportion of patients who are recurrence-free at three years. Will use a one-sided 90% confidence interval.

Secondary Outcome Measures

  1. Clinical response rate for patients harboring deleterious DDR gene alterations [After 6 courses (84 days)]

    Will be defined as the number of patients with less than a cT1 response divided by the total number of patients harboring deleterious DDR gene alterations who completed 6 cycles of dose dense gemcitabine and cisplatin.

  2. Bladder-intact survival in DDR-altered patients with < cT1 responses who selected the bladder sparing approach [Time from registration up to 5 years]

    Will be estimated with Kaplan-Meier estimators and corresponding 95% confidence intervals.

  3. Overall survival [Time from study registration up to 5 years]

    Will be estimated with Kaplan-Meier estimators and corresponding 95% confidence intervals.

  4. Pathologic response (pT0) rate at cystectomy in participants without DDR gene alterations [Up to 5 years]

    This will be the number of patients without DDR gene alterations with pT0 at cystectomy divided by the number of patients without DDR gene alterations who underwent cystectomy following the completion of dose dense gemcitabine and cisplatin treatment. Will be estimated with a binomial point estimate and corresponding 95% binomial confidence intervals.

  5. Recurrence-free survival [Time from study registration up to 5 years]

    The Kaplan-Meier estimator will be used to estimate the proportion of patients who are recurrence-free success at three years under the two alternative definitions of recurrence-free success above. The point estimate for the three-year recurrence free survival rate will be reported with a 95% confidence interval. These analyses will also be repeated for 5-year recurrence free survival.

  6. The rate of cystectomies in patients with a DDR alteration and with a cT0/CIS/Ta response [Within 3 years]

    Will be computed as the number of patients with a DDR alteration and with a cT0/CIS/Ta response who undergo a cystectomy within 3 years divided by the total number of patients with a DDR alteration and with a cT0/CIS/Ta response. Will be estimated with a binomial point estimate and corresponding 95% binomial confidence intervals.

  7. Proportion of patients in the bladder-sparing group who undergo local therapy [Up to 5 years]

    Will be estimated with a binomial point estimate and 95% binomial confidence interval. The estimate will be determined as the number of patients who undergo local treatment (BCG or resection of non-invasive disease) in the bladder-sparing group divided by the total number of patients in the bladder-sparing group.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Fairbanks Memorial Hospital Fairbanks Alaska United States 99701
2 CTCA at Western Regional Medical Center Goodyear Arizona United States 85338
3 Cancer Center at Saint Joseph's Phoenix Arizona United States 85004
4 Mercy Hospital Fort Smith Fort Smith Arkansas United States 72903
5 CHI Saint Vincent Cancer Center Hot Springs Hot Springs Arkansas United States 71913
6 Cedars Sinai Medical Center Los Angeles California United States 90048
7 Fremont - Rideout Cancer Center Marysville California United States 95901
8 University of California Davis Comprehensive Cancer Center Sacramento California United States 95817
9 Pacific Central Coast Health Center-San Luis Obispo San Luis Obispo California United States 93401
10 Mission Hope Medical Oncology - Santa Maria Santa Maria California United States 93444
11 Rocky Mountain Cancer Centers-Aurora Aurora Colorado United States 80012
12 The Medical Center of Aurora Aurora Colorado United States 80012
13 Rocky Mountain Cancer Centers-Boulder Boulder Colorado United States 80304
14 Penrose-Saint Francis Healthcare Colorado Springs Colorado United States 80907
15 Rocky Mountain Cancer Centers-Penrose Colorado Springs Colorado United States 80907
16 Saint Francis Cancer Center Colorado Springs Colorado United States 80923
17 Porter Adventist Hospital Denver Colorado United States 80210
18 Presbyterian - Saint Lukes Medical Center - Health One Denver Colorado United States 80218
19 Mercy Medical Center Durango Colorado United States 81301
20 Southwest Oncology PC Durango Colorado United States 81301
21 Mountain Blue Cancer Care Center - Swedish Englewood Colorado United States 80113
22 Swedish Medical Center Englewood Colorado United States 80113
23 The Melanoma and Skin Cancer Institute Englewood Colorado United States 80113
24 Mountain Blue Cancer Care Center Golden Colorado United States 80401
25 North Colorado Medical Center Greeley Colorado United States 80631
26 Rocky Mountain Cancer Centers-Lakewood Lakewood Colorado United States 80228
27 Saint Anthony Hospital Lakewood Colorado United States 80228
28 Rocky Mountain Cancer Centers-Littleton Littleton Colorado United States 80120
29 Littleton Adventist Hospital Littleton Colorado United States 80122
30 Sky Ridge Medical Center Lone Tree Colorado United States 80124
31 Longmont United Hospital Longmont Colorado United States 80501
32 Rocky Mountain Cancer Centers-Longmont Longmont Colorado United States 80501
33 McKee Medical Center Loveland Colorado United States 80539
34 Parker Adventist Hospital Parker Colorado United States 80138
35 Rocky Mountain Cancer Centers-Parker Parker Colorado United States 80138
36 Saint Mary Corwin Medical Center Pueblo Colorado United States 81004
37 Rocky Mountain Cancer Centers - Pueblo Pueblo Colorado United States 81008
38 Rocky Mountain Cancer Centers-Thornton Thornton Colorado United States 80260
39 Hartford Hospital Hartford Connecticut United States 06102
40 Midstate Medical Center Meriden Connecticut United States 06451
41 The Hospital of Central Connecticut New Britain Connecticut United States 06050
42 Holy Cross Hospital Fort Lauderdale Florida United States 33308
43 University of Florida Health Science Center - Gainesville Gainesville Florida United States 32610
44 Saint Alphonsus Cancer Care Center-Boise Boise Idaho United States 83706
45 Saint Alphonsus Cancer Care Center-Caldwell Caldwell Idaho United States 83605
46 Kootenai Health - Coeur d'Alene Coeur d'Alene Idaho United States 83814
47 Walter Knox Memorial Hospital Emmett Idaho United States 83617
48 Idaho Urologic Institute-Meridian Meridian Idaho United States 83642
49 Saint Alphonsus Medical Center-Nampa Nampa Idaho United States 83686
50 Kootenai Clinic Cancer Services - Post Falls Post Falls Idaho United States 83854
51 Kootenai Cancer Clinic Sandpoint Idaho United States 83864
52 Rush - Copley Medical Center Aurora Illinois United States 60504
53 Illinois CancerCare-Bloomington Bloomington Illinois United States 61704
54 Illinois CancerCare-Canton Canton Illinois United States 61520
55 Memorial Hospital of Carbondale Carbondale Illinois United States 62902
56 SIH Cancer Institute Carterville Illinois United States 62918
57 Illinois CancerCare-Carthage Carthage Illinois United States 62321
58 Centralia Oncology Clinic Centralia Illinois United States 62801
59 University of Illinois Chicago Illinois United States 60612
60 Carle on Vermilion Danville Illinois United States 61832
61 Cancer Care Specialists of Illinois - Decatur Decatur Illinois United States 62526
62 Decatur Memorial Hospital Decatur Illinois United States 62526
63 Illinois CancerCare-Dixon Dixon Illinois United States 61021
64 Carle Physician Group-Effingham Effingham Illinois United States 62401
65 Crossroads Cancer Center Effingham Illinois United States 62401
66 Illinois CancerCare-Eureka Eureka Illinois United States 61530
67 Illinois CancerCare-Galesburg Galesburg Illinois United States 61401
68 Western Illinois Cancer Treatment Center Galesburg Illinois United States 61401
69 Ingalls Memorial Hospital Harvey Illinois United States 60426
70 Illinois CancerCare-Kewanee Clinic Kewanee Illinois United States 61443
71 Illinois CancerCare-Macomb Macomb Illinois United States 61455
72 Carle Physician Group-Mattoon/Charleston Mattoon Illinois United States 61938
73 Good Samaritan Regional Health Center Mount Vernon Illinois United States 62864
74 Cancer Care Center of O'Fallon O'Fallon Illinois United States 62269
75 Illinois CancerCare-Ottawa Clinic Ottawa Illinois United States 61350
76 Illinois CancerCare-Pekin Pekin Illinois United States 61554
77 OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois United States 61554
78 Illinois CancerCare-Peoria Peoria Illinois United States 61615
79 OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois United States 61615
80 Methodist Medical Center of Illinois Peoria Illinois United States 61636
81 OSF Saint Francis Medical Center Peoria Illinois United States 61637
82 Illinois CancerCare-Peru Peru Illinois United States 61354
83 Valley Radiation Oncology Peru Illinois United States 61354
84 Illinois CancerCare-Princeton Princeton Illinois United States 61356
85 Southern Illinois University School of Medicine Springfield Illinois United States 62702
86 Springfield Clinic Springfield Illinois United States 62702
87 Memorial Medical Center Springfield Illinois United States 62781
88 Southwest Illinois Health Services LLP Swansea Illinois United States 62226
89 Carle Cancer Center Urbana Illinois United States 61801
90 The Carle Foundation Hospital Urbana Illinois United States 61801
91 Illinois CancerCare - Washington Washington Illinois United States 61571
92 Reid Health Richmond Indiana United States 47374
93 Saint Anthony Regional Hospital Carroll Iowa United States 51401
94 Medical Oncology and Hematology Associates-West Des Moines Clive Iowa United States 50325
95 Mercy Cancer Center-West Lakes Clive Iowa United States 50325
96 Alegent Health Mercy Hospital Council Bluffs Iowa United States 51503
97 Greater Regional Medical Center Creston Iowa United States 50801
98 Iowa Methodist Medical Center Des Moines Iowa United States 50309
99 Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa United States 50309
100 Broadlawns Medical Center Des Moines Iowa United States 50314
101 Medical Oncology and Hematology Associates-Laurel Des Moines Iowa United States 50314
102 Mercy Medical Center - Des Moines Des Moines Iowa United States 50314
103 Iowa Lutheran Hospital Des Moines Iowa United States 50316
104 Trinity Regional Medical Center Fort Dodge Iowa United States 50501
105 Methodist West Hospital West Des Moines Iowa United States 50266-7700
106 Mercy Medical Center-West Lakes West Des Moines Iowa United States 50266
107 Central Care Cancer Center - Garden City Garden City Kansas United States 67846
108 Central Care Cancer Center - Great Bend Great Bend Kansas United States 67530
109 University of Kansas Cancer Center Kansas City Kansas United States 66160
110 University of Kansas Hospital-Westwood Cancer Center Westwood Kansas United States 66205
111 Flaget Memorial Hospital Bardstown Kentucky United States 40004
112 Commonwealth Cancer Center-Corbin Corbin Kentucky United States 40701
113 Saint Joseph Radiation Oncology Resource Center Lexington Kentucky United States 40504
114 Saint Joseph Hospital East Lexington Kentucky United States 40509
115 Saint Joseph London London Kentucky United States 40741
116 Jewish Hospital Louisville Kentucky United States 40202
117 Saints Mary and Elizabeth Hospital Louisville Kentucky United States 40215
118 UofL Health Medical Center Northeast Louisville Kentucky United States 40245
119 Jewish Hospital Medical Center South Shepherdsville Kentucky United States 40165
120 LSU Health Baton Rouge-North Clinic Baton Rouge Louisiana United States 70805
121 Our Lady of The Lake Baton Rouge Louisiana United States 70808
122 Louisiana Hematology Oncology Associates LLC Baton Rouge Louisiana United States 70809
123 Mary Bird Perkins Cancer Center Baton Rouge Louisiana United States 70809
124 Our Lady of the Lake Physicians Group - Medical Oncology Baton Rouge Louisiana United States 70809
125 Northshore Oncology Associates-Covington Covington Louisiana United States 70433
126 Terrebonne General Medical Center Houma Louisiana United States 70360
127 East Jefferson General Hospital Metairie Louisiana United States 70006
128 LSU Healthcare Network / Metairie Multi-Specialty Clinic Metairie Louisiana United States 70006
129 Louisiana State University Health Science Center New Orleans Louisiana United States 70112
130 University Medical Center New Orleans New Orleans Louisiana United States 70112
131 Ochsner Medical Center Jefferson New Orleans Louisiana United States 70121
132 Maryland Proton Treatment Center Baltimore Maryland United States 21201
133 University of Maryland/Greenebaum Cancer Center Baltimore Maryland United States 21201
134 Central Maryland Radiation Oncology in Howard County Columbia Maryland United States 21044
135 UM Baltimore Washington Medical Center/Tate Cancer Center Glen Burnie Maryland United States 21061
136 Mercy Medical Center Springfield Massachusetts United States 01104
137 Saint Joseph Mercy Hospital Ann Arbor Michigan United States 48106
138 Saint Joseph Mercy Brighton Brighton Michigan United States 48114
139 Trinity Health IHA Medical Group Hematology Oncology - Brighton Brighton Michigan United States 48114
140 Saint Joseph Mercy Canton Canton Michigan United States 48188
141 Trinity Health IHA Medical Group Hematology Oncology - Canton Canton Michigan United States 48188
142 Caro Cancer Center Caro Michigan United States 48723
143 Saint Joseph Mercy Chelsea Chelsea Michigan United States 48118
144 Trinity Health IHA Medical Group Hematology Oncology - Chelsea Hospital Chelsea Michigan United States 48118
145 Hematology Oncology Consultants-Clarkston Clarkston Michigan United States 48346
146 Newland Medical Associates-Clarkston Clarkston Michigan United States 48346
147 Ascension Saint John Hospital Detroit Michigan United States 48236
148 Great Lakes Cancer Management Specialists-Doctors Park East China Township Michigan United States 48054
149 Genesee Cancer and Blood Disease Treatment Center Flint Michigan United States 48503
150 Genesee Hematology Oncology PC Flint Michigan United States 48503
151 Genesys Hurley Cancer Institute Flint Michigan United States 48503
152 Hurley Medical Center Flint Michigan United States 48503
153 Academic Hematology Oncology Specialists Grosse Pointe Woods Michigan United States 48236
154 Great Lakes Cancer Management Specialists-Van Elslander Cancer Center Grosse Pointe Woods Michigan United States 48236
155 Michigan Breast Specialists-Grosse Pointe Woods Grosse Pointe Woods Michigan United States 48236
156 Sparrow Hospital Lansing Michigan United States 48912
157 Hope Cancer Clinic Livonia Michigan United States 48154
158 Trinity Health Saint Mary Mercy Livonia Hospital Livonia Michigan United States 48154
159 Great Lakes Cancer Management Specialists-Macomb Medical Campus Macomb Michigan United States 48044
160 Michigan Breast Specialists-Macomb Township Macomb Michigan United States 48044
161 Saint Mary's Oncology/Hematology Associates of Marlette Marlette Michigan United States 48453
162 21st Century Oncology-Pontiac Pontiac Michigan United States 48341
163 Hope Cancer Center Pontiac Michigan United States 48341
164 Newland Medical Associates-Pontiac Pontiac Michigan United States 48341
165 Saint Joseph Mercy Oakland Pontiac Michigan United States 48341
166 Great Lakes Cancer Management Specialists-Rochester Hills Rochester Hills Michigan United States 48309
167 Ascension Saint Mary's Hospital Saginaw Michigan United States 48601
168 Oncology Hematology Associates of Saginaw Valley PC Saginaw Michigan United States 48604
169 Bhadresh Nayak MD PC-Sterling Heights Sterling Heights Michigan United States 48312
170 Ascension Saint Joseph Hospital Tawas City Michigan United States 48764
171 Advanced Breast Care Center PLLC Warren Michigan United States 48088
172 Great Lakes Cancer Management Specialists-Macomb Professional Building Warren Michigan United States 48093
173 Macomb Hematology Oncology PC Warren Michigan United States 48093
174 Michigan Breast Specialists-Warren Warren Michigan United States 48093
175 Saint John Macomb-Oakland Hospital Warren Michigan United States 48093
176 Saint Mary's Oncology/Hematology Associates of West Branch West Branch Michigan United States 48661
177 Huron Gastroenterology PC Ypsilanti Michigan United States 48106
178 Trinity Health IHA Medical Group Hematology Oncology Ann Arbor Campus Ypsilanti Michigan United States 48197
179 Sanford Joe Lueken Cancer Center Bemidji Minnesota United States 56601
180 Essentia Health Saint Joseph's Medical Center Brainerd Minnesota United States 56401
181 Fairview Ridges Hospital Burnsville Minnesota United States 55337
182 Minnesota Oncology - Burnsville Burnsville Minnesota United States 55337
183 Mercy Hospital Coon Rapids Minnesota United States 55433
184 Essentia Health - Deer River Clinic Deer River Minnesota United States 56636
185 Essentia Health Saint Mary's - Detroit Lakes Clinic Detroit Lakes Minnesota United States 56501
186 Essentia Health Cancer Center Duluth Minnesota United States 55805
187 Essentia Health Saint Mary's Medical Center Duluth Minnesota United States 55805
188 Miller-Dwan Hospital Duluth Minnesota United States 55805
189 Fairview Southdale Hospital Edina Minnesota United States 55435
190 Lake Region Healthcare Corporation-Cancer Care Fergus Falls Minnesota United States 56537
191 Essentia Health - Fosston Fosston Minnesota United States 56542
192 Unity Hospital Fridley Minnesota United States 55432
193 Essentia Health Hibbing Clinic Hibbing Minnesota United States 55746
194 Fairview Clinics and Surgery Center Maple Grove Maple Grove Minnesota United States 55369
195 Minnesota Oncology Hematology PA-Maplewood Maplewood Minnesota United States 55109
196 Saint John's Hospital - Healtheast Maplewood Minnesota United States 55109
197 Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
198 Hennepin County Medical Center Minneapolis Minnesota United States 55415
199 Health Partners Inc Minneapolis Minnesota United States 55454
200 Monticello Cancer Center Monticello Minnesota United States 55362
201 New Ulm Medical Center New Ulm Minnesota United States 56073
202 Essentia Health - Park Rapids Park Rapids Minnesota United States 56470
203 North Memorial Medical Health Center Robbinsdale Minnesota United States 55422
204 Coborn Cancer Center at Saint Cloud Hospital Saint Cloud Minnesota United States 56303
205 Park Nicollet Clinic - Saint Louis Park Saint Louis Park Minnesota United States 55416
206 Regions Hospital Saint Paul Minnesota United States 55101
207 United Hospital Saint Paul Minnesota United States 55102
208 Essentia Health Sandstone Sandstone Minnesota United States 55072
209 Saint Francis Regional Medical Center Shakopee Minnesota United States 55379
210 Lakeview Hospital Stillwater Minnesota United States 55082
211 Sanford Thief River Falls Medical Center Thief River Falls Minnesota United States 56701
212 Essentia Health Virginia Clinic Virginia Minnesota United States 55792
213 Ridgeview Medical Center Waconia Minnesota United States 55387
214 Rice Memorial Hospital Willmar Minnesota United States 56201
215 Minnesota Oncology Hematology PA-Woodbury Woodbury Minnesota United States 55125
216 Sanford Cancer Center Worthington Worthington Minnesota United States 56187
217 Fairview Lakes Medical Center Wyoming Minnesota United States 55092
218 Saint Louis Cancer and Breast Institute-Ballwin Ballwin Missouri United States 63011
219 Central Care Cancer Center - Bolivar Bolivar Missouri United States 65613
220 Parkland Health Center-Bonne Terre Bonne Terre Missouri United States 63628
221 Saint Francis Medical Center Cape Girardeau Missouri United States 63703
222 Southeast Cancer Center Cape Girardeau Missouri United States 63703
223 University of Missouri - Ellis Fischel Columbia Missouri United States 65212
224 Siteman Cancer Center at West County Hospital Creve Coeur Missouri United States 63141
225 Parkland Health Center - Farmington Farmington Missouri United States 63640
226 Capital Region Southwest Campus Jefferson City Missouri United States 65109
227 Freeman Health System Joplin Missouri United States 64804
228 Mercy Hospital Joplin Joplin Missouri United States 64804
229 Delbert Day Cancer Institute at PCRMC Rolla Missouri United States 65401
230 Mercy Clinic-Rolla-Cancer and Hematology Rolla Missouri United States 65401
231 Heartland Regional Medical Center Saint Joseph Missouri United States 64506
232 Washington University School of Medicine Saint Louis Missouri United States 63110
233 Mercy Hospital South Saint Louis Missouri United States 63128
234 Siteman Cancer Center-South County Saint Louis Missouri United States 63129
235 Missouri Baptist Medical Center Saint Louis Missouri United States 63131
236 Siteman Cancer Center at Christian Hospital Saint Louis Missouri United States 63136
237 Mercy Hospital Saint Louis Saint Louis Missouri United States 63141
238 Sainte Genevieve County Memorial Hospital Sainte Genevieve Missouri United States 63670
239 Mercy Hospital Springfield Springfield Missouri United States 65804
240 CoxHealth South Hospital Springfield Missouri United States 65807
241 Missouri Baptist Sullivan Hospital Sullivan Missouri United States 63080
242 Missouri Baptist Outpatient Center-Sunset Hills Sunset Hills Missouri United States 63127
243 Community Hospital of Anaconda Anaconda Montana United States 59711
244 Billings Clinic Cancer Center Billings Montana United States 59101
245 Bozeman Deaconess Hospital Bozeman Montana United States 59715
246 Benefis Healthcare- Sletten Cancer Institute Great Falls Montana United States 59405
247 Great Falls Clinic Great Falls Montana United States 59405
248 Saint Peter's Community Hospital Helena Montana United States 59601
249 Kalispell Regional Medical Center Kalispell Montana United States 59901
250 Community Medical Hospital Missoula Montana United States 59804
251 CHI Health Saint Francis Grand Island Nebraska United States 68803
252 Heartland Hematology and Oncology Kearney Nebraska United States 68845
253 CHI Health Good Samaritan Kearney Nebraska United States 68847
254 Saint Elizabeth Regional Medical Center Lincoln Nebraska United States 68510
255 Alegent Health Immanuel Medical Center Omaha Nebraska United States 68122
256 Hematology and Oncology Consultants PC Omaha Nebraska United States 68122
257 Alegent Health Bergan Mercy Medical Center Omaha Nebraska United States 68124
258 Alegent Health Lakeside Hospital Omaha Nebraska United States 68130
259 Creighton University Medical Center Omaha Nebraska United States 68131
260 Midlands Community Hospital Papillion Nebraska United States 68046
261 Memorial Sloan Kettering Basking Ridge Basking Ridge New Jersey United States 07920
262 Englewood Hospital and Medical Center Englewood New Jersey United States 07631
263 Memorial Sloan Kettering Monmouth Middletown New Jersey United States 07748
264 Memorial Sloan Kettering Bergen Montvale New Jersey United States 07645
265 Roswell Park Cancer Institute Buffalo New York United States 14263
266 Memorial Sloan Kettering Commack Commack New York United States 11725
267 Memorial Sloan Kettering Westchester Harrison New York United States 10604
268 Memorial Sloan Kettering Cancer Center New York New York United States 10065
269 NYP/Weill Cornell Medical Center New York New York United States 10065
270 Upstate Cancer Center at Oswego Oswego New York United States 13126
271 State University of New York Upstate Medical University Syracuse New York United States 13210
272 Memorial Sloan Kettering Nassau Uniondale New York United States 11553
273 Southeastern Medical Oncology Center-Clinton Clinton North Carolina United States 28328
274 Southeastern Medical Oncology Center-Goldsboro Goldsboro North Carolina United States 27534
275 Wayne Memorial Hospital Goldsboro North Carolina United States 27534
276 Onslow Memorial Hospital Jacksonville North Carolina United States 28546
277 Southeastern Medical Oncology Center-Jacksonville Jacksonville North Carolina United States 28546
278 Sanford Bismarck Medical Center Bismarck North Dakota United States 58501
279 Essentia Health Cancer Center-South University Clinic Fargo North Dakota United States 58103
280 Sanford South University Medical Center Fargo North Dakota United States 58103
281 Sanford Medical Center Fargo Fargo North Dakota United States 58104
282 Sanford Broadway Medical Center Fargo North Dakota United States 58122
283 Sanford Roger Maris Cancer Center Fargo North Dakota United States 58122
284 Essentia Health - Jamestown Clinic Jamestown North Dakota United States 58401
285 Indu and Raj Soin Medical Center Beavercreek Ohio United States 45431
286 Saint Elizabeth Boardman Hospital Boardman Ohio United States 44512
287 Dayton Physicians LLC-Miami Valley South Centerville Ohio United States 45459
288 Miami Valley Hospital South Centerville Ohio United States 45459
289 Good Samaritan Hospital - Cincinnati Cincinnati Ohio United States 45220
290 Oncology Hematology Care Inc-Kenwood Cincinnati Ohio United States 45236
291 Bethesda North Hospital Cincinnati Ohio United States 45242
292 TriHealth Cancer Institute-Westside Cincinnati Ohio United States 45247
293 TriHealth Cancer Institute-Anderson Cincinnati Ohio United States 45255
294 Cleveland Clinic Foundation Cleveland Ohio United States 44195
295 Ohio State University Comprehensive Cancer Center Columbus Ohio United States 43210
296 Good Samaritan Hospital - Dayton Dayton Ohio United States 45406
297 Miami Valley Hospital Dayton Ohio United States 45409
298 Dayton Physician LLC-Miami Valley Hospital North Dayton Ohio United States 45415
299 Miami Valley Hospital North Dayton Ohio United States 45415
300 Armes Family Cancer Center Findlay Ohio United States 45840
301 Blanchard Valley Hospital Findlay Ohio United States 45840
302 Orion Cancer Care Findlay Ohio United States 45840
303 Atrium Medical Center-Middletown Regional Hospital Franklin Ohio United States 45005-1066
304 Dayton Physicians LLC-Atrium Franklin Ohio United States 45005
305 Dayton Physicians LLC-Wayne Greenville Ohio United States 45331
306 Wayne Hospital Greenville Ohio United States 45331
307 Greater Dayton Cancer Center Kettering Ohio United States 45409
308 First Dayton Cancer Care Kettering Ohio United States 45420
309 Kettering Medical Center Kettering Ohio United States 45429
310 Springfield Regional Cancer Center Springfield Ohio United States 45504
311 Springfield Regional Medical Center Springfield Ohio United States 45505
312 Dayton Physicians LLC-Upper Valley Troy Ohio United States 45373
313 Upper Valley Medical Center Troy Ohio United States 45373
314 Saint Joseph Warren Hospital Warren Ohio United States 44484
315 Saint Elizabeth Youngstown Hospital Youngstown Ohio United States 44501
316 University of Oklahoma Health Sciences Center Oklahoma City Oklahoma United States 73104
317 Mercy Hospital Oklahoma City Oklahoma City Oklahoma United States 73120
318 Oklahoma Cancer Specialists and Research Institute-Tulsa Tulsa Oklahoma United States 74146
319 Saint Alphonsus Medical Center-Baker City Baker City Oregon United States 97814
320 Saint Alphonsus Medical Center-Ontario Ontario Oregon United States 97914
321 Lehigh Valley Hospital-Cedar Crest Allentown Pennsylvania United States 18103
322 Lehigh Valley Hospital - Muhlenberg Bethlehem Pennsylvania United States 18017
323 Geisinger Medical Center Danville Pennsylvania United States 17822
324 Pocono Medical Center East Stroudsburg Pennsylvania United States 18301
325 Geisinger Medical Center-Cancer Center Hazleton Hazleton Pennsylvania United States 18201
326 Lehigh Valley Hospital-Hazleton Hazleton Pennsylvania United States 18201
327 Geisinger Medical Oncology-Lewisburg Lewisburg Pennsylvania United States 17837
328 Lewistown Hospital Lewistown Pennsylvania United States 17044
329 Geisinger Cancer Services-Pottsville Pottsville Pennsylvania United States 17901
330 Community Medical Center Scranton Pennsylvania United States 18510
331 Geisinger Medical Oncology-Selinsgrove Selinsgrove Pennsylvania United States 17870
332 Geisinger Wyoming Valley/Henry Cancer Center Wilkes-Barre Pennsylvania United States 18711
333 Prisma Health Cancer Institute - Spartanburg Boiling Springs South Carolina United States 29316
334 Medical University of South Carolina Charleston South Carolina United States 29425
335 Prisma Health Cancer Institute - Laurens Clinton South Carolina United States 29325
336 Prisma Health Cancer Institute - Easley Easley South Carolina United States 29640
337 Gibbs Cancer Center-Gaffney Gaffney South Carolina United States 29341
338 Prisma Health Cancer Institute - Butternut Greenville South Carolina United States 29605
339 Prisma Health Cancer Institute - Faris Greenville South Carolina United States 29605
340 Prisma Health Greenville Memorial Hospital Greenville South Carolina United States 29605
341 Prisma Health Cancer Institute - Eastside Greenville South Carolina United States 29615
342 Prisma Health Cancer Institute - Greer Greer South Carolina United States 29650
343 Gibbs Cancer Center-Pelham Greer South Carolina United States 29651
344 Prisma Health Cancer Institute - Seneca Seneca South Carolina United States 29672
345 Spartanburg Medical Center Spartanburg South Carolina United States 29303
346 MGC Hematology Oncology-Union Union South Carolina United States 29379
347 Sanford Cancer Center Oncology Clinic Sioux Falls South Dakota United States 57104
348 Sanford USD Medical Center - Sioux Falls Sioux Falls South Dakota United States 57117-5134
349 Memorial Hospital Chattanooga Tennessee United States 37404
350 Pulmonary Medicine Center of Chattanooga-Hixson Hixson Tennessee United States 37343
351 Memorial GYN Plus Ooltewah Tennessee United States 37363
352 Saint Joseph Regional Cancer Center Bryan Texas United States 77802
353 Parkland Memorial Hospital Dallas Texas United States 75235
354 UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas United States 75390
355 UT Southwestern/Simmons Cancer Center-Fort Worth Fort Worth Texas United States 76104
356 UT Southwestern Clinical Center at Richardson/Plano Richardson Texas United States 75080
357 Harrison HealthPartners Hematology and Oncology-Bremerton Bremerton Washington United States 98310
358 Harrison Medical Center Bremerton Washington United States 98310
359 Highline Medical Center-Main Campus Burien Washington United States 98166
360 Saint Elizabeth Hospital Enumclaw Washington United States 98022
361 Saint Francis Hospital Federal Way Washington United States 98003
362 Saint Clare Hospital Lakewood Washington United States 98499
363 Harrison HealthPartners Hematology and Oncology-Poulsbo Poulsbo Washington United States 98370
364 Franciscan Research Center-Northwest Medical Plaza Tacoma Washington United States 98405
365 Northwest Medical Specialties PLLC Tacoma Washington United States 98405
366 United Hospital Center Bridgeport West Virginia United States 26330
367 WVUH-Berkely Medical Center Martinsburg West Virginia United States 25401
368 West Virginia University Healthcare Morgantown West Virginia United States 26506
369 Camden Clark Medical Center Parkersburg West Virginia United States 26101
370 Langlade Hospital and Cancer Center Antigo Wisconsin United States 54409
371 Duluth Clinic Ashland Ashland Wisconsin United States 54806
372 Northwest Wisconsin Cancer Center Ashland Wisconsin United States 54806
373 Marshfield Medical Center-EC Cancer Center Eau Claire Wisconsin United States 54701
374 Essentia Health-Hayward Clinic Hayward Wisconsin United States 54843
375 Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
376 Marshfield Clinic - Ladysmith Center Ladysmith Wisconsin United States 54848
377 Marshfield Medical Center-Marshfield Marshfield Wisconsin United States 54449
378 Aspirus Medford Hospital Medford Wisconsin United States 54451
379 Marshfield Clinic-Minocqua Center Minocqua Wisconsin United States 54548
380 Cancer Center of Western Wisconsin New Richmond Wisconsin United States 54017
381 Marshfield Medical Center-Rice Lake Rice Lake Wisconsin United States 54868
382 Essentia Health-Spooner Clinic Spooner Wisconsin United States 54801
383 Marshfield Medical Center-River Region at Stevens Point Stevens Point Wisconsin United States 54482
384 Essentia Health Saint Mary's Hospital - Superior Superior Wisconsin United States 54880
385 Aspirus Regional Cancer Center Wausau Wisconsin United States 54401
386 Diagnostic and Treatment Center Weston Wisconsin United States 54476
387 Marshfield Medical Center - Weston Weston Wisconsin United States 54476
388 Aspirus Cancer Care - Wisconsin Rapids Wisconsin Rapids Wisconsin United States 54494
389 Billings Clinic-Cody Cody Wyoming United States 82414
390 Welch Cancer Center Sheridan Wyoming United States 82801

Sponsors and Collaborators

  • Alliance for Clinical Trials in Oncology
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Gopa Iyer, MD, Memorial Sloan Kettering Cancer Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT03609216
Other Study ID Numbers:
  • A031701
  • NCI-2018-01531
  • U10CA180821
First Posted:
Aug 1, 2018
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Additional relevant MeSH terms:
Carcinoma
Carcinoma, Transitional Cell
Gemcitabine

Study Results

No Results Posted as of Aug 3, 2022