Chemotherapy Before Surgery in Treating Patients With High Grade Upper Urinary Tract Cancer



Status:Active, not recruiting
Healthy:No
Age Range:18 - Any
Updated:7/28/2018
Start Date:April 2015

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A Prospective Phase II Trial of Neoadjuvant Systemic Chemotherapy Followed by Extirpative Surgery for Patients With High Grade Upper Tract Urothelial Carcinoma

This phase II trial studies how well giving chemotherapy before surgery works in treating
patients with aggressive upper urinary tract cancer. Drugs used in chemotherapy, such as
methotrexate, vinblastine, doxorubicin hydrochloride, cisplatin, gemcitabine hydrochloride,
and carboplatin, 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. Removing the
affected upper urinary tract by surgery is the recommended treatment for upper urinary tract
cancer, but can cause loss of kidney function and prevent patients from being able to receive
chemotherapy after surgery. Giving chemotherapy before surgery, when the kidneys are working
at their maximum, may allow less tissue to be removed during surgery and may be more
effective in treating patients with high grade upper urinary tract cancer.

PRIMARY OBJECTIVES:

I. To evaluate the rate of complete pathologic response (pCR = pT0pN0) as assessed by
standard pathologic review attained by neoadjuvant systemic chemotherapy and
nephroureterectomy.

SECONDARY OBJECTIVES:

I. To evaluate the safety of neoadjuvant systemic chemotherapy in patients with upper tract
urothelial carcinoma preceding nephroureterectomy.

II. To evaluate recurrence-free survival of patients treated with neoadjuvant systemic
chemotherapy preceding nephroureterectomy.

III. To evaluate event-free survival of patients treated with neoadjuvant systemic
chemotherapy preceding nephroureterectomy.

IV. To evaluate bladder cancer-free survival of patients treated with neoadjuvant systemic
chemotherapy preceding nephroureterectomy.

V. To evaluate cancer specific survival of patients treated with neoadjuvant systemic
chemotherapy preceding nephroureterectomy.

VI. To evaluate renal functional outcomes of patients treated with neoadjuvant systemic
chemotherapy preceding nephroureterectomy.

TERTIARY OBJECTIVES:

I. To collect pre-treatment and post-treatment tumor tissue, peripheral blood mononuclear
cell (PBMC), peripheral blood plasma, and urine specimens for potential evaluations of
markers of chemotherapy response/resistance.

OUTLINE: Patients are assigned to 1 of 2 treatment arms based on baseline renal function.

ARM A (CREATININE CLEARANCE [CRCL] >= 50): Patients receive methotrexate intravenously (IV)
over 2-3 minutes, vinblastine IV, doxorubicin hydrochloride IV, and cisplatin IV over 4 hours
on day 1. Treatment repeats every 14 days for 4 courses in the absence of disease progression
or unacceptable toxicity. Patients without metastatic disease undergo nephroureterectomy and
lymph node dissection 21-60 days after completion of chemotherapy.

ARM B (30 =< CRCL < 50): Patients receive gemcitabine hydrochloride IV over 30-60 minutes on
days 1 and 8 and carboplatin IV over 30-60 minutes on day 1. Treatment repeats every 21 days
for 4 courses in the absence of disease progression or unacceptable toxicity. Patients
without metastatic disease undergo nephroureterectomy and lymph node dissection 21-60 days
after completion of chemotherapy.

After completion of study treatment, patients are followed up every 3 months for 2 years and
then every 6 months for 3 years.

Inclusion Criteria:

- Patients must have high grade upper tract urothelial carcinoma proven by one of the
following:

- Biopsy;

- Urinary cytology with a 3-dimensional upper urinary tract mass on cross-sectional
imaging; or

- Urinary cytology and a mass visualized during upper urinary tract endoscopy

- Patients must have a creatinine clearance >= 30 ml/min as determined by
Cockcroft-Gault calculation or 24-hour urine creatinine clearance measurement within
28 days of registration to be eligible for the study

- Patients must have Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- Patients must have no evidence of metastatic disease or clinically enlarged lymph
nodes on computed tomography (CT) or magnetic resonance imaging (MRI) of the abdomen
and pelvis and CT chest obtained within 28 days of registration (a negative biopsy is
required for lymph nodes > 1 cm in size to confirm lack of involvement); patients with
lymph nodes > 1 cm in whom a biopsy is deemed not feasible are not eligible; patients
with elevated alkaline phosphatase or suspicious bone pain should also undergo
baseline bone scans to evaluate for bone metastasis

- Patients with any component of small cell carcinoma are not eligible; other variant
histologies are permitted provided the predominant (>= 50%) subtype is urothelial
carcinoma

- Patients must not have peripheral neuropathy > grade 2

- Patients must not have a history of allergy or hypersensitivity to methotrexate,
vinblastine, doxorubicin (doxorubicin hydrochloride), cisplatin, gemcitabine
(gemcitabine hydrochloride), carboplatin or filgrastim or pegfilgrastim

- Patients must have a left ventricular ejection fraction (LVEF) >= 50% by (either
multigated acquisition [MUGA] or 2-dimensional [2-D] echocardiogram) within 28 days of
registration

- Absolute neutrophil count (ANC) >= 1500/mm^3

- Platelets >= 100,000/mm^3

- Hemoglobin (HgB) >= 9

- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT])
< 2 X institutional upper limit of normal (ULN)

- Bilirubin within institutional normal limits (or < 2.5 X the ULN for patients with
Gilbert's disease)

- Patients with concomitant primaries of the bladder/urethra are allowed, as long as
these sites are surgically resected and non-invasive cancers (< cT1N0)

- Patients must not have another active second malignancy other than non-melanoma skin
cancers and biochemical relapsed prostate cancer; patients that have completed all
necessary therapy and are considered to be at less than 30% risk of relapse are not
considered to have an active second malignancy and are eligible for enrollment

- For patients who have creatinine clearance that meets >= 50 ml/min they must not have
received prior systemic doxorubicin

- Patients with uncontrolled illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, myocardial infarction in last 3
months, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social
situations that would limit compliance with study requirements are not eligible

- Patients who are known to have human immunodeficiency virus (HIV) or are on
combination antiretroviral therapy are ineligible

- Patients must have no prior radiation therapy to >= 25% of the bone marrow for other
diseases or prior systemic anthracycline therapy; prior intravesical anthracycline
therapy for non-muscle invasive urothelial carcinoma of the bladder is permitted

- Patients may have a history of resectable urothelial cancer (including neoadjuvant
chemotherapy) as long as patients meet one of the following:

- pT0, Tis, or T1N0 and have no evidence of disease (NED) for more than 2 years
from surgery or chemotherapy;

- pT2-3aN0 and NED for more than 3 years from surgery or chemotherapy; or

- > pT3b, or N+ and NED for more than 5 years from surgery or chemotherapy

- Women must not be pregnant or breast-feeding; all females of childbearing potential
must have a blood test or urine study within 2 weeks prior to registration to rule out
pregnancy; a female of childbearing potential is any woman, regardless of sexual
orientation or whether they have undergone tubal ligation, who meets the following
criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not
been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses
at any time in the preceding 24 consecutive months)

- Women of childbearing potential and sexually active males must use an accepted and
effective method of contraception or to abstain from sexual intercourse for the
duration of their participation in the study
We found this trial at
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211 Saint Francis Drive
Cape Girardeau, Missouri 63703
573-331-3000
Principal Investigator: James L. Wade
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1 Hurley Plaza
Flint, Michigan 48503
(810) 262-9000
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Hurley Medical Center From its founding in 1908, Hurley Medical Center has devoted itself to...
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5301 McAuley Drive
Ann Arbor, Michigan 48197
734-712-3456
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Saint Joseph Mercy Hospital St. Joseph Mercy Ann Arbor Hospital is a 537-bed teaching hospital...
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1500 East Medical Center Drive
Ann Arbor, Michigan 48109
800-865-1125
Principal Investigator: Ajjai S. Alva
University of Michigan Comprehensive Cancer Center The U-M Comprehensive Cancer Center's mission is the conquest...
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13001 E. 17th Pl.
Aurora, Colorado 80045
303-724-5000
Principal Investigator: Elizabeth R. Kessler
Phone: 720-848-0650
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Birmingham, Alabama 35233
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Phone: 205-934-0309
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Bloomington, Illinois 61701
Principal Investigator: James L. Wade
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1505 Eastland Drive
Bloomington, Illinois 61701
309-662-2102
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare-Bloomington Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Boise, Idaho 83706
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1501 North Oakland Drive
Bolivar, Missouri 65613
417-326-7200
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Phone: 800-821-7532
Central Care Cancer Center at Carrie J. Babb Cancer Center Cancer treatment often requires a...
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Bonne Terre, Missouri 63628
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Branson, Missouri 65616
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Burlington, Wisconsin 53105
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210 W Walnut St
Canton, Illinois 61520
309-647-5240
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789 Mt Auburn Rd
Cape Girardeau, Missouri 63703
(573) 519-4725
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Southeast Cancer Center SoutheastHEALTH is a far-reaching network of providers and facilities including Southeast Hospital...
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Carbondale, Illinois 62902
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160 S Adams St
Carthage, Illinois 62321
(217) 357-6877
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Illinois CancerCare - Carthage Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Centerville, Ohio 45459
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Centralia, Illinois 62801
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Chadds Ford, Pennsylvania 19317
Principal Investigator: Gregory A. Masters
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171 Ashley Avenue
Charleston, South Carolina 29425
843-792-1414
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Cincinnati, Ohio 45202
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Cincinnati, Ohio 45211
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Cincinnati, Ohio 45230
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Cincinnati, Ohio 45236
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Cincinnati, Ohio 45242
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Colorado Springs, Colorado 80903
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Crestview Hills, Kentucky 41017
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Dallas, Texas 75390
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Danville, Illinois 61832
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100 North Academy Avenue
Danville, Pennsylvania 17822
570-271-6211
Principal Investigator: Joseph J. Vadakara
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Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
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1 Wyoming St,
Dayton, Ohio 45409
(937) 208-8000
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2222 Philadelphia Dr
Dayton, Ohio 45406
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9000 N. Main St.
Dayton, Ohio 45415
(937) 734-6784
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Samaritan North Health Center Good Samaritan Hospital (GSH) is passionate about providing the most recent...
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Dearborn, Michigan 48123
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Decatur, Illinois 62526
Principal Investigator: James L. Wade
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2300 N Edward St
Decatur, Illinois 62526
(217) 876-8121
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Decatur Memorial Hospital An American flag bearing only 48 stars waved above Decatur Memorial Hospital...
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22101 Moross Rd
Detroit, Michigan 48236
(313) 343-4000
Principal Investigator: Christopher M. Reynolds
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Saint John Hospital and Medical Center Founded in 1952, St. John Hospital and Medical Center...
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Effingham, Illinois 62401
Principal Investigator: Vamsi K. Vasireddy
Phone: 800-446-5532
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Effingham, Illinois 62401
Principal Investigator: James L. Wade
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101 S Major St
Eureka, Illinois 61530
309-467-2371
Principal Investigator: James L. Wade
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Fairfield, Ohio 45014
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1900 S Main St
Findlay, Ohio 45840
(419) 423-4500
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Blanchard Valley Hospital For more than 100 years, Blanchard Valley Hospital has made quality care...
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302 Kensington Ave
Flint, Michigan 48503
(810) 762-8490
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Genesys Hurley Cancer Institute Bringing the most advanced cancer treatment services, technologies and programs available...
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1024 S Lemay Ave
Fort Collins, Colorado 80524
(970) 495-7000
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Poudre Valley Hospital A 270-bed regional medical center offering a wide array of treatments, surgeries,...
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One Medical Center Drive
Franklin, Ohio 45005
(513) 424-2111
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Atrium Medical Center - Middletown Regional Hospital Atrium Medical Center (Atrium) is built on the...
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Franklin, Tennessee 37067
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Galesburg, Illinois 61401
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3315 N Seminary St
Galesburg, Illinois 61401
309-344-9269
Principal Investigator: James L. Wade
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Illinois CancerCare - Galesburg Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Grafton, Wisconsin 53024
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835 Sweitzer St
Greenville, Ohio 45331
(937) 548-1141
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Wayne Hospital Stretching back to our roots nearly 100 years ago, Wayne HealthCare has always...
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114 Woodland St
Hartford, Connecticut 06105
(860) 714-4000
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Saint Francis Hospital and Medical Center Saint Francis Hospital and Medical Center has come a...
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Hazleton, Pennsylvania 18201
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205 NE Ave
Jackson, Michigan 49201
(517) 788-4800
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Allegiance Health Allegiance Health is a community-owned and locally-governed health system in Jackson, Michigan. We...
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1432 Southwest Blvd.
Jefferson City, Missouri 65109
(573) 632-4800
Principal Investigator: James L. Wade
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Capital Region Medical Center-Goldschmidt Cancer Center At the Goldschmidt Cancer Center in Jefferson City, board...
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Joplin, Missouri 64804
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1102 W 32nd St
Joplin, Missouri 64804
(417) 347-1111
Principal Investigator: Jay W. Carlson
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Freeman Health System Freeman in Joplin, Missouri, is a 485-bed, three-hospital system providing comprehensive healthcare...
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3535 Southern Blvd
Kettering, Ohio 45429
(937) 298-4331
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Kettering Medical Center Our flagship hospital, Kettering Medical Center, stands proudly in Kettering, Ohio. From...
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205 Tenney St
Kewanee, Illinois 61443
309-852-0596
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Illinois CancerCare - Kewanee Clinic Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer...
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1215 E Michigan Ave
Lansing, Michigan 48912
(517) 364-1000
Principal Investigator: Christopher M. Reynolds
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Sparrow Hospital Sparrow has grown to become the region's largest health system, and its diverse...
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424 Savannah Rd
Lewes, Delaware 19958
(302) 645-3300
Principal Investigator: Gregory A. Masters
Phone: 302-733-6227
Beebe Medical Center Located in beautiful historic Lewes, Delaware, near Rehoboth Beach, Beebe Healthcare offers...
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Lewisburg, Pennsylvania 17837
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400 Highland Ave
Lewistown, Pennsylvania 17044
(717) 248-5411
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Livonia, Michigan 48154
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501 E Grant
Macomb, Illinois 61455
309-833-3503
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4061 Old Peshtigo Rd
Marinette, Wisconsin 54143
(715) 732-8100
Principal Investigator: Rubina Qamar
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Vince Lombardi Cancer Clinic - Marinette Established in 2006, Vince Lombardi Cancer Clinic in Marinette...
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Mattoon, Illinois 61938
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Menomonee Falls, Wisconsin 53051
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Michigan City, Indiana 46360
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Michigan City, Indiana 46360
Principal Investigator: Vamsi K. Vasireddy
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Milwaukee, Wisconsin 53209
Principal Investigator: Rubina Qamar
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1 Good Samaritan Way
Mount Vernon, Illinois 62864
(618) 242-4600
Principal Investigator: Jay W. Carlson
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Good Samaritan Regional Health Center St. Mary's Good Samaritan, Incorporated (SMGSI) was created in 1996...
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Nashville, Tennessee 37204
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Nashville, Tennessee 37232
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New Orleans, Louisiana 70121
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
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Newark, Delaware
Principal Investigator: Gregory A. Masters
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Newark, Delaware 19713
Principal Investigator: Gregory A. Masters
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4755 Ogletown-Stanton Road
Newark, Delaware 19718
302-733-1000
Principal Investigator: Gregory A. Masters
Phone: 302-733-6227
Christiana Care Health System - Christiana Hospital A 913-bed, 1.3-million-square-foot, modern facility in Newark, Delaware,...
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940 NE 13th St
Oklahoma City, Oklahoma 73190
(405) 271-6458
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Phone: 405-271-4272
University of Oklahoma Health Sciences Center The OU Health Sciences Center is composed of seven...
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855 N. Westhaven Dr.
Oshkosh, Wisconsin 54904
920-303-8700
Principal Investigator: Rubina Qamar
Phone: 888-709-2080
Vince Lombardi Cancer Clinic - Oshkosh When the diagnosis is cancer, one of the most...
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Oshkosh, WI
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Ottawa, Illinois 61350
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Ottawa, IL
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1200 Starfire Drive
Ottawa, Illinois 61350
815-431-9270
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare-Ottawa Clinic Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases....
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Ottawa, IL
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603 S 13th St
Pekin, Illinois 61554
(309) 353-0214
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare - Pekin Illinois CancerCare is one of the largest private oncology and hematology...
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600 S 13th St
Pekin, Illinois 61554
(309) 347-1151
Principal Investigator: James L. Wade
Phone: 217-876-4740
Pekin Cancer Treatment Center Since 1913, Pekin Hospital has been dedicated to improving the health...
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Peoria, Illinois 61615
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Peoria, Illinois 61637
Principal Investigator: James L. Wade
Phone: 217-876-4740
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221 NE Glen Oak Ave
Peoria, Illinois 61636
(309) 672-5522
Principal Investigator: James L. Wade
Phone: 217-876-4740
Methodist Medical Center of Illinois UnityPoint Health is one of the nation's most integrated health...
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Peoria, IL
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8940 Wood Sage Rd
Peoria, Illinois 61615
(309) 243-3000
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare-Peoria Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood diseases. Our...
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Peru, Illinois 61354
Principal Investigator: James L. Wade
Phone: 217-876-4740
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Peru, IL
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4391 Venture Dr.
Peru, Illinois 61354
815-223-7010
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare - Peru Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Philadelphia, Pennsylvania 19103
Principal Investigator: Vitaly Margulis
Phone: 214-648-0567
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Philadelphia, PA
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111 S 11th St
Philadelphia, Pennsylvania 19107
(215) 955-6000
Principal Investigator: Jean H. Hoffman-Censits
Phone: 215-955-6084
Thomas Jefferson University Hospital Our hospitals in Center City Philadelphia share a 13-acre campus with...
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Pontiac, Michigan 48341
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-4673
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Pontiac, MI
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2601 Electric Ave
Port Huron, Michigan 48060
(810) 985-1500
Principal Investigator: Christopher M. Reynolds
Phone: 734-712-4673
Saint Joseph Mercy Port Huron St. Joseph Mercy Hospital, Port Huron, MI is a 164-bed...
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Port Huron, MI
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Pottsville, Pennsylvania 17901
Principal Investigator: Joseph J. Vadakara
Phone: 570-271-5251
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530 Park Ave East
Princeton, Illinois 61356
815-875-3010
Principal Investigator: James L. Wade
Phone: 217-876-4740
Illinois CancerCare - Princeton Illinois CancerCare, P.C. is a comprehensive practice treating patients withcancer andblood...
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Princeton, IL
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Racine, Wisconsin 53406
Principal Investigator: Rubina Qamar
Phone: 888-709-2080
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Racine, WI
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Rehoboth Beach, Delaware 19971
Principal Investigator: Gregory A. Masters
Phone: 302-733-6227
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