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

Sponsor
Eastern Cooperative Oncology Group (Other)
Overall Status
Completed
CT.gov ID
NCT00053209
Collaborator
National Cancer Institute (NCI) (NIH)
46
Enrollment
121
Locations
1
Arm
61
Duration (Months)
0.4
Patients Per Site
0
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: gemcitabine hydrochloride
  • Drug: pemetrexed disodium
 Phase 2

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
46 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer
Study Start Date :
Apr 1, 2004
Actual Primary Completion Date :
Sep 1, 2007
Actual Study Completion Date :
May 1, 2009

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pemetrexed Disodium and Gemcitabine

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

Drug: gemcitabine hydrochloride

Drug: pemetrexed disodium

Outcome Measures

Primary Outcome Measures

  1. Response as measured by RECIST criteria [Assessed every 6 weeks]

Secondary Outcome Measures

  1. Time to disease progression [Assessed every 6 weeks]

  2. Overall survival [Assessed every 3 months for 2 years, then every 6 months for 3 years]

Eligibility Criteria

Criteria

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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Aurora Presbyterian Hospital Aurora Colorado United States 80012
2 Boulder Community Hospital Boulder Colorado United States 80301
3 Penrose Cancer Center at Penrose Hospital Colorado Springs Colorado United States 80933
4 Porter Adventist Hospital Denver Colorado United States 80210
5 Presbyterian - St. Luke's Medical Center Denver Colorado United States 80218
6 St. Joseph Hospital Denver Colorado United States 80218
7 Rose Medical Center Denver Colorado United States 80220
8 CCOP - Colorado Cancer Research Program, Incorporated Denver Colorado United States 80224-2522
9 Swedish Medical Center Englewood Colorado United States 80110
10 Sky Ridge Medical Center Lone Tree Colorado United States 80124
11 Hope Cancer Care Center at Longmont United Hospital Longmont Colorado United States 80502
12 St. Mary-Corwin Regional Medical Center Pueblo Colorado United States 81004
13 North Suburban Medical Center Thorton Colorado United States 80229
14 Yale Comprehensive Cancer Center at Yale University School of Medicine New Haven Connecticut United States 06520-8032
15 Beebe Medical Center Lewes Delaware United States 19958
16 CCOP - Christiana Care Health Services Newark Delaware United States 19718
17 St. Francis Hospital Wilmington Delaware United States 19805
18 Baptist Cancer Institute - Jacksonville Jacksonville Florida United States 32207
19 Watson Clinic, LLC Lakeland Florida United States 33805
20 Hematology and Oncology of Northeast Georgia Athens Georgia United States 30607
21 MBCCOP-Medical College of Georgia Cancer Center Augusta Georgia United States 30912
22 Rush-Copley Cancer Care Center Aurora Illinois United States 60507
23 Hinsdale Hematology Oncology Associates Hinsdale Illinois United States 60521
24 Joliet Oncology Hematology Associates, Limited - West Joliet Illinois United States 60435
25 Regional Cancer Center at Memorial Medical Center Springfield Illinois United States 62781-0001
26 Carle Cancer Center at Carle Foundation Hospital Urbana Illinois United States 61801
27 CCOP - Carle Cancer Center Urbana Illinois United States 61801
28 Elkhart General Hospital Elkhart Indiana United States 46515
29 Center for Cancer Therapy at LaPorte Hospital and Health Services La Porte Indiana United States 46350
30 Saint Anthony Memorial Health Centers Michigan City Indiana United States 46360
31 Saint Joseph Regional Medical Center - Plymouth Campus Plymouth Indiana United States 46544
32 CCOP - Northern Indiana CR Consortium South Bend Indiana United States 46601
33 Memorial Hospital of South Bend South Bend Indiana United States 46601
34 McFarland Clinic, P.C. Ames Iowa United States 50010
35 Siouxland Regional Cancer Center Sioux City Iowa United States 51101-1733
36 Siouxland Hematology-Oncology Associates Sioux City Iowa United States 51101
37 Mercy Medical Center - Sioux City Sioux City Iowa United States 51104
38 St. Luke's Regional Medical Center Sioux City Iowa United States 51104
39 Cancer Center of Kansas - Chanute Chanute Kansas United States 66720
40 Cancer Center of Kansas - Dodge City Dodge City Kansas United States 67801
41 Cancer Center of Kansas, P.A. - El Dorado El Dorado Kansas United States 67042
42 Cancer Center of Kansas - Kingman Kingman Kansas United States 67068
43 Southwest Medical Center Liberal Kansas United States 67901
44 Cancer Center of Kansas - Newton Newton Kansas United States 67114
45 Cancer Center of Kansas, P.A. - Parsons Parsons Kansas United States 67357
46 Pratt Cancer Center of Kansas Pratt Kansas United States 67124
47 Cancer Center of Kansas - Salina Salina Kansas United States 67042
48 Cancer Center of Kansas - Wellington Wellington Kansas United States 67152
49 Associates in Womens Health Wichita Kansas United States 67203
50 Cancer Center of Kansas, P.A. Wichita Kansas United States 67208
51 Cancer Center of Kansas, P.A. - Wichita Wichita Kansas United States 67214
52 CCOP - Wichita Wichita Kansas United States 67214
53 Via Christi Cancer Center at Via Christi Regional Medical Center Wichita Kansas United States 67214
54 Cancer Center of Kansas - Winfield Winfield Kansas United States 67156
55 Union Hospital Cancer Center at Union Hospital Elkton MD Maryland United States 21921
56 Green Bay Oncology, Limited - Escanaba Escanaba Michigan United States 49431
57 Green Bay Oncology, Limited - Iron Mountain Iron Mountain Michigan United States 49801
58 Borgess Medical Center Kalamazooaa Michigan United States 49001
59 Bronson Methodist Hospital Kalamazoo Michigan United States 49007
60 West Michigan Cancer Center Kalamazoo Michigan United States 49007
61 MeritCare Clinic - Bemidji Bemidji Minnesota United States 56601
62 Fairview Ridges Hospital Burnsville Minnesota United States 55337
63 Mercy and Unity Cancer Center at Mercy Hospital Coon Rapids Minnesota United States 55433
64 CCOP - Duluth Duluth Minnesota United States 55805
65 Miller-Dwan Medical Center Duluth Minnesota United States 55805
66 St. Mary's - Duluth Clinic Cancer Center Duluth Minnesota United States 55805
67 Fairview Southdale Hospital Edina Minnesota United States 55435
68 Mercy and Unity Cancer Center at Unity Hospital Fridley Minnesota United States 55432
69 Hutchinson Area Health Care Hutchinson Minnesota United States 55350
70 Meeker County Memorial Hospital Litchfield Minnesota United States 55355
71 St. John's Hospital Maplewood Minnesota United States 55109
72 Virginia Piper Cancer Institute at Abbott-Northwestern Hospital Minneapolis Minnesota United States 55407
73 Hennepin County Medical Center - Minneapolis Minneapolis Minnesota United States 55415
74 Hubert H. Humphrey Cancer Center at North Memorial Medical Center Robbinsdale Minnesota United States 55422
75 CCOP - Metro-Minnesota Saint Louis Park Minnesota United States 55416
76 Regions Hospital Cancer Care Center Saint Paul Minnesota United States 55101
77 Saint Francis Cancer Center Shakopee Minnesota United States 55379
78 St. Joseph's Hospital St Paul Minnesota United States 55102
79 Park Nicollet Health Services St. Louis Park Minnesota United States 55416
80 United Hospital St. Paul Minnesota United States 55102
81 Ridgeview Medical Center Waconia Minnesota United States 55387
82 Woodwinds Hospital Woodbury Minnesota United States 55125
83 Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees Camden New Jersey United States 08103
84 Veterans Affairs Medical Center - East Orange East Orange New Jersey United States 07018-1095
85 CCOP - Northern New Jersey Hackensack New Jersey United States 07601
86 Cancer Institute of New Jersey at Hamilton Hamilton New Jersey United States 08690
87 Fox Chase Virtua Health Cancer Program - Marlton Marlton New Jersey United States 08053
88 Mountainside Hospital Cancer Center Montclair New Jersey United States 07042
89 Carol G. Simon Cancer Center at Morristown Memorial Hospital Morristown New Jersey United States 07962
90 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School New Brunswick New Jersey United States 08903
91 Overlook Hospital Summit New Jersey United States 07902
92 Our Lady of Mercy Medical Center Comprehensive Cancer Center Bronx New York United States 10466
93 CCOP - MeritCare Hospital Fargo North Dakota United States 58122
94 MeritCare Medical Group Fargo North Dakota United States 58122
95 Aultman Hospital Cancer Center at Aultman Health Foundation Canton Ohio United States 44710
96 Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University Cleveland Ohio United States 44106
97 MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland Ohio United States 44109
98 Cleveland Clinic Taussig Cancer Center Cleveland Ohio United States 44195
99 Natalie Warren Bryant Cancer Center at St. Francis Hospital Tulsa Oklahoma United States 74136
100 St. Luke's Hospital Cancer Center Bethlehem Pennsylvania United States 18015
101 Central Pennsylvania Hematology and Medical Oncology Associates, P. C. Lemoyne Pennsylvania United States 17043
102 Abramson Cancer Center of the University of Pennsylvania Philadelphia Pennsylvania United States 19104
103 Fox Chase-Temple Cancer Center Philadelphia Pennsylvania United States 19111-2497
104 Chester County Hospital West Chester Pennsylvania United States 19380
105 Reading Hospital and Medical Center West Reading Pennsylvania United States 19612
106 Cancer Care Institute of Carolina at Aiken Regional Medical Centers Aiken South Carolina United States 29802
107 Sioux Valley Hospital and University of South Dakota Medical Center Sioux Falls South Dakota United States 57104
108 Avera McKennan Hospital and University Health Center Sioux Falls South Dakota United States 57105
109 Medical X-Ray Center Sioux Falls South Dakota United States 57105
110 Erlanger Cancer Center Chattanooga Tennessee United States 37403
111 Vanderbilt-Ingram Cancer Center Nashville Tennessee United States 37232
112 CCOP - Scott and White Hospital Temple Texas United States 76508
113 Green Bay Oncology, Limited at St. Vincent Hospital Green Bay Wisconsin United States 54301-3526
114 St. Vincent Hospital Green Bay Wisconsin United States 54301
115 Green Bay Oncology, Limited at St. Mary's Hospital Green Bay Wisconsin United States 54303
116 St. Mary's Hospital Medical Center Green Bay Wisconsin United States 54303
117 Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center La Crosse Wisconsin United States 54601
118 University of Wisconsin Comprehensive Cancer Center Madison Wisconsin United States 53792
119 Cancer Care Center at Holy Family Memorial Medical Center Manitowoc Wisconsin United States 54221
120 Green Bay Oncology, Limited - Oconto Falls Oconto Falls Wisconsin United States 54154
121 Green Bay Oncology, Limited - Sturgeon Bay Sturgeon Bay Wisconsin United States 54235

Sponsors and Collaborators

  • Eastern Cooperative Oncology Group
  • National Cancer Institute (NCI)

Investigators

  • Study Chair: Robert Dreicer, MD, FACP, The Cleveland Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00053209
Other Study ID Numbers:
  • CDR0000269302
  • ECOG-E4802
First Posted:
Jan 28, 2003
Last Update Posted:
Dec 4, 2012
Last Verified:
Nov 1, 2012
Keywords provided by Eastern Cooperative Oncology Group
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
Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urethral Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Gemcitabine
Pemetrexed

Study Results

No Results Posted as of Dec 4, 2012