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Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

Primary Purpose

Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
gemcitabine hydrochloride
pemetrexed disodium
Sponsored by
Eastern Cooperative Oncology Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bladder Cancer focused on measuring metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra) Any of the following types: Transitional cell carcinoma (TCC) Mixed histologies containing a component of TCC Non-TCC of the urothelium (renal pelvis, ureter, bladder, or urethra) Progressing regional or metastatic disease Measurable disease No clinical evidence of CNS metastases No evidence of clinically significant (by physical exam or plain film) third-space fluid collections (pleural effusions or ascites) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic AST no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal Creatinine clearance at least 45 mL/min Cardiovascular No history of severe cardiovascular disease (i.e., American Heart Association class III or IV heart disease) No uncontrolled congestive heart failure No ventricular dysrhythmias Other Not pregnant or nursing Fertile patients must use effective contraception No active unresolved infection No other prior malignancy unless curatively treated and disease free for an appropriate (disease-specific) period of time Able and willing to receive folic acid and cyanocobalamin supplementation PRIOR CONCURRENT THERAPY: Biologic therapy No prior systemic biologic response modifier therapy Chemotherapy No prior systemic chemotherapy for metastatic disease More than 1 year since prior neoadjuvant or adjuvant chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy and recovered No prior pelvic radiotherapy No concurrent radiotherapy Surgery At least 4 weeks since prior major surgery and recovered Other More than 7 days since prior parenteral antibiotics No salicylates for 2 days before, during, and for 2 days after administration of pemetrexed disodium No nonsteroidal anti-inflammatory drugs for at least 5 days before, during, and for 2 days after administration of pemetrexed disodium

Sites / Locations

  • Aurora Presbyterian Hospital
  • Boulder Community Hospital
  • Penrose Cancer Center at Penrose Hospital
  • Porter Adventist Hospital
  • Presbyterian - St. Luke's Medical Center
  • St. Joseph Hospital
  • Rose Medical Center
  • CCOP - Colorado Cancer Research Program, Incorporated
  • Swedish Medical Center
  • Sky Ridge Medical Center
  • Hope Cancer Care Center at Longmont United Hospital
  • St. Mary-Corwin Regional Medical Center
  • North Suburban Medical Center
  • Yale Comprehensive Cancer Center at Yale University School of Medicine
  • Beebe Medical Center
  • CCOP - Christiana Care Health Services
  • St. Francis Hospital
  • Baptist Cancer Institute - Jacksonville
  • Watson Clinic, LLC
  • Hematology and Oncology of Northeast Georgia
  • MBCCOP-Medical College of Georgia Cancer Center
  • Rush-Copley Cancer Care Center
  • Hinsdale Hematology Oncology Associates
  • Joliet Oncology Hematology Associates, Limited - West
  • Regional Cancer Center at Memorial Medical Center
  • Carle Cancer Center at Carle Foundation Hospital
  • CCOP - Carle Cancer Center
  • Elkhart General Hospital
  • Center for Cancer Therapy at LaPorte Hospital and Health Services
  • Saint Anthony Memorial Health Centers
  • Saint Joseph Regional Medical Center - Plymouth Campus
  • CCOP - Northern Indiana CR Consortium
  • Memorial Hospital of South Bend
  • McFarland Clinic, P.C.
  • Siouxland Regional Cancer Center
  • Siouxland Hematology-Oncology Associates
  • Mercy Medical Center - Sioux City
  • St. Luke's Regional Medical Center
  • Cancer Center of Kansas - Chanute
  • Cancer Center of Kansas - Dodge City
  • Cancer Center of Kansas, P.A. - El Dorado
  • Cancer Center of Kansas - Kingman
  • Southwest Medical Center
  • Cancer Center of Kansas - Newton
  • Cancer Center of Kansas, P.A. - Parsons
  • Pratt Cancer Center of Kansas
  • Cancer Center of Kansas - Salina
  • Cancer Center of Kansas - Wellington
  • Associates in Womens Health
  • Cancer Center of Kansas, P.A.
  • Cancer Center of Kansas, P.A. - Wichita
  • CCOP - Wichita
  • Via Christi Cancer Center at Via Christi Regional Medical Center
  • Cancer Center of Kansas - Winfield
  • Union Hospital Cancer Center at Union Hospital
  • Green Bay Oncology, Limited - Escanaba
  • Green Bay Oncology, Limited - Iron Mountain
  • Borgess Medical Center
  • Bronson Methodist Hospital
  • West Michigan Cancer Center
  • MeritCare Clinic - Bemidji
  • Fairview Ridges Hospital
  • Mercy and Unity Cancer Center at Mercy Hospital
  • CCOP - Duluth
  • Miller-Dwan Medical Center
  • St. Mary's - Duluth Clinic Cancer Center
  • Fairview Southdale Hospital
  • Mercy and Unity Cancer Center at Unity Hospital
  • Hutchinson Area Health Care
  • Meeker County Memorial Hospital
  • St. John's Hospital
  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
  • Hennepin County Medical Center - Minneapolis
  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center
  • CCOP - Metro-Minnesota
  • Park Nicollet Health Services
  • Regions Hospital Cancer Care Center
  • St. Joseph's Hospital
  • United Hospital
  • Saint Francis Cancer Center
  • Ridgeview Medical Center
  • Woodwinds Hospital
  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
  • Veterans Affairs Medical Center - East Orange
  • CCOP - Northern New Jersey
  • Cancer Institute of New Jersey at Hamilton
  • Fox Chase Virtua Health Cancer Program - Marlton
  • Mountainside Hospital Cancer Center
  • Carol G. Simon Cancer Center at Morristown Memorial Hospital
  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
  • Overlook Hospital
  • Our Lady of Mercy Medical Center Comprehensive Cancer Center
  • CCOP - MeritCare Hospital
  • MeritCare Medical Group
  • Aultman Hospital Cancer Center at Aultman Health Foundation
  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
  • MetroHealth's Cancer Care Center at MetroHealth Medical Center
  • Cleveland Clinic Taussig Cancer Center
  • Natalie Warren Bryant Cancer Center at St. Francis Hospital
  • St. Luke's Hospital Cancer Center
  • Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
  • Abramson Cancer Center of the University of Pennsylvania
  • Fox Chase-Temple Cancer Center
  • Chester County Hospital
  • Reading Hospital and Medical Center
  • Cancer Care Institute of Carolina at Aiken Regional Medical Centers
  • Sioux Valley Hospital and University of South Dakota Medical Center
  • Avera McKennan Hospital and University Health Center
  • Medical X-Ray Center
  • Erlanger Cancer Center
  • Vanderbilt-Ingram Cancer Center
  • CCOP - Scott and White Hospital
  • Green Bay Oncology, Limited at St. Vincent Hospital
  • St. Vincent Hospital
  • Green Bay Oncology, Limited at St. Mary's Hospital
  • St. Mary's Hospital Medical Center
  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
  • University of Wisconsin Comprehensive Cancer Center
  • Cancer Care Center at Holy Family Memorial Medical Center
  • Green Bay Oncology, Limited - Oconto Falls
  • Green Bay Oncology, Limited - Sturgeon Bay

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pemetrexed Disodium and Gemcitabine

Arm Description

Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles

Outcomes

Primary Outcome Measures

Response as measured by RECIST criteria

Secondary Outcome Measures

Time to disease progression
Overall survival

Full Information

First Posted
January 27, 2003
Last Updated
June 20, 2023
Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00053209
Brief Title
Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
Official Title
Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
August 10, 2004 (Actual)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Eastern Cooperative Oncology Group
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Pemetrexed disodium may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop tumor cells from dividing so they stop growing or die. Combining pemetrexed disodium with gemcitabine may kill more tumor cells. PURPOSE: Phase II trial to study the effectiveness of combining pemetrexed disodium with gemcitabine in treating patients who have advanced cancer of the urothelium.
Detailed Description
OBJECTIVES: Primary Determine the response rate in patients with previously untreated advanced cancer of the urothelium treated with pemetrexed disodium and gemcitabine. Determine the toxicity of this regimen in these patients. Secondary Determine the overall survival and time to progression in patients treated with this regimen. OUTLINE: This is a multicenter study. Patients receive pemetrexed disodium IV over 10 minutes on day 1 and gemcitabine IV over 30 minutes on days 1 and 8. Patients also receive cyanocobalamin intramuscularly once every 9 weeks and folic acid orally once daily beginning on day -6 and continuing until 3 weeks after the completion of study therapy. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease progression or unacceptable toxicity. Patients are followed every 3 months for 2 years and then every 6 months for 3 years. PROJECTED ACCRUAL: A total of 24-46 patients will be accrued for this study within 15 -18 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer
Keywords
metastatic transitional cell cancer of the renal pelvis and ureter, recurrent transitional cell cancer of the renal pelvis and ureter, regional transitional cell cancer of the renal pelvis and ureter, transitional cell carcinoma of the bladder, recurrent bladder cancer, stage III bladder cancer, stage IV bladder cancer, anterior urethral cancer, posterior urethral cancer, recurrent urethral cancer, urethral cancer associated with invasive bladder cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pemetrexed Disodium and Gemcitabine
Arm Type
Experimental
Arm Description
Pemetrexed disodium 500 mg/m2 followed by gemcitabine 1000 mg/m2 on day 1 and gemcitabine 1000 mg/m2 on day 8 of a 21-day cycle for a maximum of 6 cycles
Intervention Type
Drug
Intervention Name(s)
gemcitabine hydrochloride
Intervention Type
Drug
Intervention Name(s)
pemetrexed disodium
Primary Outcome Measure Information:
Title
Response as measured by RECIST criteria
Time Frame
Assessed every 6 weeks
Secondary Outcome Measure Information:
Title
Time to disease progression
Time Frame
Assessed every 6 weeks
Title
Overall survival
Time Frame
Assessed every 3 months for 2 years, then every 6 months for 3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or urethra) Any of the following types: Transitional cell carcinoma (TCC) Mixed histologies containing a component of TCC Non-TCC of the urothelium (renal pelvis, ureter, bladder, or urethra) Progressing regional or metastatic disease Measurable disease No clinical evidence of CNS metastases No evidence of clinically significant (by physical exam or plain film) third-space fluid collections (pleural effusions or ascites) PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy Not specified Hematopoietic Granulocyte count at least 1,500/mm^3 Platelet count at least 100,000/mm^3 Hemoglobin at least 9 g/dL Hepatic AST no greater than 3 times upper limit of normal (ULN) Bilirubin no greater than 1.5 times ULN Renal Creatinine clearance at least 45 mL/min Cardiovascular No history of severe cardiovascular disease (i.e., American Heart Association class III or IV heart disease) No uncontrolled congestive heart failure No ventricular dysrhythmias Other Not pregnant or nursing Fertile patients must use effective contraception No active unresolved infection No other prior malignancy unless curatively treated and disease free for an appropriate (disease-specific) period of time Able and willing to receive folic acid and cyanocobalamin supplementation PRIOR CONCURRENT THERAPY: Biologic therapy No prior systemic biologic response modifier therapy Chemotherapy No prior systemic chemotherapy for metastatic disease More than 1 year since prior neoadjuvant or adjuvant chemotherapy Endocrine therapy Not specified Radiotherapy At least 4 weeks since prior radiotherapy and recovered No prior pelvic radiotherapy No concurrent radiotherapy Surgery At least 4 weeks since prior major surgery and recovered Other More than 7 days since prior parenteral antibiotics No salicylates for 2 days before, during, and for 2 days after administration of pemetrexed disodium No nonsteroidal anti-inflammatory drugs for at least 5 days before, during, and for 2 days after administration of pemetrexed disodium
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Dreicer, MD, FACP
Organizational Affiliation
The Cleveland Clinic
Official's Role
Study Chair
Facility Information:
Facility Name
Aurora Presbyterian Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012
Country
United States
Facility Name
Boulder Community Hospital
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80301
Country
United States
Facility Name
Penrose Cancer Center at Penrose Hospital
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80933
Country
United States
Facility Name
Porter Adventist Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80210
Country
United States
Facility Name
Presbyterian - St. Luke's Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
St. Joseph Hospital
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Rose Medical Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
Facility Name
CCOP - Colorado Cancer Research Program, Incorporated
City
Denver
State/Province
Colorado
ZIP/Postal Code
80224-2522
Country
United States
Facility Name
Swedish Medical Center
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80110
Country
United States
Facility Name
Sky Ridge Medical Center
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Hope Cancer Care Center at Longmont United Hospital
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80502
Country
United States
Facility Name
St. Mary-Corwin Regional Medical Center
City
Pueblo
State/Province
Colorado
ZIP/Postal Code
81004
Country
United States
Facility Name
North Suburban Medical Center
City
Thornton
State/Province
Colorado
ZIP/Postal Code
80229
Country
United States
Facility Name
Yale Comprehensive Cancer Center at Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06520-8032
Country
United States
Facility Name
Beebe Medical Center
City
Lewes
State/Province
Delaware
ZIP/Postal Code
19958
Country
United States
Facility Name
CCOP - Christiana Care Health Services
City
Newark
State/Province
Delaware
ZIP/Postal Code
19718
Country
United States
Facility Name
St. Francis Hospital
City
Wilmington
State/Province
Delaware
ZIP/Postal Code
19805
Country
United States
Facility Name
Baptist Cancer Institute - Jacksonville
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Watson Clinic, LLC
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Hematology and Oncology of Northeast Georgia
City
Athens
State/Province
Georgia
ZIP/Postal Code
30607
Country
United States
Facility Name
MBCCOP-Medical College of Georgia Cancer Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Rush-Copley Cancer Care Center
City
Aurora
State/Province
Illinois
ZIP/Postal Code
60507
Country
United States
Facility Name
Hinsdale Hematology Oncology Associates
City
Hinsdale
State/Province
Illinois
ZIP/Postal Code
60521
Country
United States
Facility Name
Joliet Oncology Hematology Associates, Limited - West
City
Joliet
State/Province
Illinois
ZIP/Postal Code
60435
Country
United States
Facility Name
Regional Cancer Center at Memorial Medical Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62781-0001
Country
United States
Facility Name
Carle Cancer Center at Carle Foundation Hospital
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
CCOP - Carle Cancer Center
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Elkhart General Hospital
City
Elkhart
State/Province
Indiana
ZIP/Postal Code
46515
Country
United States
Facility Name
Center for Cancer Therapy at LaPorte Hospital and Health Services
City
La Porte
State/Province
Indiana
ZIP/Postal Code
46350
Country
United States
Facility Name
Saint Anthony Memorial Health Centers
City
Michigan City
State/Province
Indiana
ZIP/Postal Code
46360
Country
United States
Facility Name
Saint Joseph Regional Medical Center - Plymouth Campus
City
Plymouth
State/Province
Indiana
ZIP/Postal Code
46544
Country
United States
Facility Name
CCOP - Northern Indiana CR Consortium
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
Memorial Hospital of South Bend
City
South Bend
State/Province
Indiana
ZIP/Postal Code
46601
Country
United States
Facility Name
McFarland Clinic, P.C.
City
Ames
State/Province
Iowa
ZIP/Postal Code
50010
Country
United States
Facility Name
Siouxland Regional Cancer Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101-1733
Country
United States
Facility Name
Siouxland Hematology-Oncology Associates
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51101
Country
United States
Facility Name
Mercy Medical Center - Sioux City
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
St. Luke's Regional Medical Center
City
Sioux City
State/Province
Iowa
ZIP/Postal Code
51104
Country
United States
Facility Name
Cancer Center of Kansas - Chanute
City
Chanute
State/Province
Kansas
ZIP/Postal Code
66720
Country
United States
Facility Name
Cancer Center of Kansas - Dodge City
City
Dodge City
State/Province
Kansas
ZIP/Postal Code
67801
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - El Dorado
City
El Dorado
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Kingman
City
Kingman
State/Province
Kansas
ZIP/Postal Code
67068
Country
United States
Facility Name
Southwest Medical Center
City
Liberal
State/Province
Kansas
ZIP/Postal Code
67901
Country
United States
Facility Name
Cancer Center of Kansas - Newton
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Parsons
City
Parsons
State/Province
Kansas
ZIP/Postal Code
67357
Country
United States
Facility Name
Pratt Cancer Center of Kansas
City
Pratt
State/Province
Kansas
ZIP/Postal Code
67124
Country
United States
Facility Name
Cancer Center of Kansas - Salina
City
Salina
State/Province
Kansas
ZIP/Postal Code
67042
Country
United States
Facility Name
Cancer Center of Kansas - Wellington
City
Wellington
State/Province
Kansas
ZIP/Postal Code
67152
Country
United States
Facility Name
Associates in Womens Health
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67203
Country
United States
Facility Name
Cancer Center of Kansas, P.A.
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67208
Country
United States
Facility Name
Cancer Center of Kansas, P.A. - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
CCOP - Wichita
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Via Christi Cancer Center at Via Christi Regional Medical Center
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67214
Country
United States
Facility Name
Cancer Center of Kansas - Winfield
City
Winfield
State/Province
Kansas
ZIP/Postal Code
67156
Country
United States
Facility Name
Union Hospital Cancer Center at Union Hospital
City
Elkton
State/Province
Maryland
ZIP/Postal Code
21921
Country
United States
Facility Name
Green Bay Oncology, Limited - Escanaba
City
Escanaba
State/Province
Michigan
ZIP/Postal Code
49431
Country
United States
Facility Name
Green Bay Oncology, Limited - Iron Mountain
City
Iron Mountain
State/Province
Michigan
ZIP/Postal Code
49801
Country
United States
Facility Name
Borgess Medical Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49001
Country
United States
Facility Name
Bronson Methodist Hospital
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
West Michigan Cancer Center
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49007
Country
United States
Facility Name
MeritCare Clinic - Bemidji
City
Bemidji
State/Province
Minnesota
ZIP/Postal Code
56601
Country
United States
Facility Name
Fairview Ridges Hospital
City
Burnsville
State/Province
Minnesota
ZIP/Postal Code
55337
Country
United States
Facility Name
Mercy and Unity Cancer Center at Mercy Hospital
City
Coon Rapids
State/Province
Minnesota
ZIP/Postal Code
55433
Country
United States
Facility Name
CCOP - Duluth
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Miller-Dwan Medical Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
St. Mary's - Duluth Clinic Cancer Center
City
Duluth
State/Province
Minnesota
ZIP/Postal Code
55805
Country
United States
Facility Name
Fairview Southdale Hospital
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Mercy and Unity Cancer Center at Unity Hospital
City
Fridley
State/Province
Minnesota
ZIP/Postal Code
55432
Country
United States
Facility Name
Hutchinson Area Health Care
City
Hutchinson
State/Province
Minnesota
ZIP/Postal Code
55350
Country
United States
Facility Name
Meeker County Memorial Hospital
City
Litchfield
State/Province
Minnesota
ZIP/Postal Code
55355
Country
United States
Facility Name
St. John's Hospital
City
Maplewood
State/Province
Minnesota
ZIP/Postal Code
55109
Country
United States
Facility Name
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55407
Country
United States
Facility Name
Hennepin County Medical Center - Minneapolis
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55415
Country
United States
Facility Name
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
City
Robbinsdale
State/Province
Minnesota
ZIP/Postal Code
55422
Country
United States
Facility Name
CCOP - Metro-Minnesota
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Park Nicollet Health Services
City
Saint Louis Park
State/Province
Minnesota
ZIP/Postal Code
55416
Country
United States
Facility Name
Regions Hospital Cancer Care Center
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55101
Country
United States
Facility Name
St. Joseph's Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
United Hospital
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States
Facility Name
Saint Francis Cancer Center
City
Shakopee
State/Province
Minnesota
ZIP/Postal Code
55379
Country
United States
Facility Name
Ridgeview Medical Center
City
Waconia
State/Province
Minnesota
ZIP/Postal Code
55387
Country
United States
Facility Name
Woodwinds Hospital
City
Woodbury
State/Province
Minnesota
ZIP/Postal Code
55125
Country
United States
Facility Name
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
City
Camden
State/Province
New Jersey
ZIP/Postal Code
08103
Country
United States
Facility Name
Veterans Affairs Medical Center - East Orange
City
East Orange
State/Province
New Jersey
ZIP/Postal Code
07018-1095
Country
United States
Facility Name
CCOP - Northern New Jersey
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Cancer Institute of New Jersey at Hamilton
City
Hamilton
State/Province
New Jersey
ZIP/Postal Code
08690
Country
United States
Facility Name
Fox Chase Virtua Health Cancer Program - Marlton
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Mountainside Hospital Cancer Center
City
Montclair
State/Province
New Jersey
ZIP/Postal Code
07042
Country
United States
Facility Name
Carol G. Simon Cancer Center at Morristown Memorial Hospital
City
Morristown
State/Province
New Jersey
ZIP/Postal Code
07962
Country
United States
Facility Name
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Overlook Hospital
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07902
Country
United States
Facility Name
Our Lady of Mercy Medical Center Comprehensive Cancer Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10466
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
MeritCare Medical Group
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
Aultman Hospital Cancer Center at Aultman Health Foundation
City
Canton
State/Province
Ohio
ZIP/Postal Code
44710
Country
United States
Facility Name
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
MetroHealth's Cancer Care Center at MetroHealth Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44109
Country
United States
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Natalie Warren Bryant Cancer Center at St. Francis Hospital
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
St. Luke's Hospital Cancer Center
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18015
Country
United States
Facility Name
Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
City
Lemoyne
State/Province
Pennsylvania
ZIP/Postal Code
17043
Country
United States
Facility Name
Abramson Cancer Center of the University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Fox Chase-Temple Cancer Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111-2497
Country
United States
Facility Name
Chester County Hospital
City
West Chester
State/Province
Pennsylvania
ZIP/Postal Code
19380
Country
United States
Facility Name
Reading Hospital and Medical Center
City
West Reading
State/Province
Pennsylvania
ZIP/Postal Code
19612
Country
United States
Facility Name
Cancer Care Institute of Carolina at Aiken Regional Medical Centers
City
Aiken
State/Province
South Carolina
ZIP/Postal Code
29802
Country
United States
Facility Name
Sioux Valley Hospital and University of South Dakota Medical Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57104
Country
United States
Facility Name
Avera McKennan Hospital and University Health Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Medical X-Ray Center
City
Sioux Falls
State/Province
South Dakota
ZIP/Postal Code
57105
Country
United States
Facility Name
Erlanger Cancer Center
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Vanderbilt-Ingram Cancer Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301-3526
Country
United States
Facility Name
St. Vincent Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54301
Country
United States
Facility Name
Green Bay Oncology, Limited at St. Mary's Hospital
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
St. Mary's Hospital Medical Center
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54303
Country
United States
Facility Name
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
University of Wisconsin Comprehensive Cancer Center
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States
Facility Name
Cancer Care Center at Holy Family Memorial Medical Center
City
Manitowoc
State/Province
Wisconsin
ZIP/Postal Code
54221
Country
United States
Facility Name
Green Bay Oncology, Limited - Oconto Falls
City
Oconto Falls
State/Province
Wisconsin
ZIP/Postal Code
54154
Country
United States
Facility Name
Green Bay Oncology, Limited - Sturgeon Bay
City
Sturgeon Bay
State/Province
Wisconsin
ZIP/Postal Code
54235
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18459175
Citation
Dreicer R, Li H, Cooney MM, Wilding G, Roth BJ; Eastern Cooperative Oncology Group. Phase 2 trial of pemetrexed disodium and gemcitabine in advanced urothelial cancer (E4802): a trial of the Eastern Cooperative Oncology Group. Cancer. 2008 Jun 15;112(12):2671-5. doi: 10.1002/cncr.23503.
Results Reference
result
Citation
Li S, Dreicer R, Roth B, et al.: Phase II trial of pemetrexed disodium and gemcitabine in advanced carcinoma of the urothelium (E4802): a trial of the Eastern Cooperative Oncology Group. [Abstract] J Clin Oncol 25 (Suppl 18): A-5079, 254s, 2007.
Results Reference
result

Learn more about this trial

Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium

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