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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier:
NCT00053209
First received: January 27, 2003
Last updated: November 30, 2012
Last verified: November 2012
  Purpose

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 Intervention Phase
Bladder Cancer
Transitional Cell Cancer of the Renal Pelvis and Ureter
Urethral Cancer
Drug: gemcitabine hydrochloride
Drug: pemetrexed disodium
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer

Resource links provided by NLM:


Further study details as provided by Eastern Cooperative Oncology Group:

Primary Outcome Measures:
  • Response as measured by RECIST criteria [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to disease progression [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ] [ Designated as safety issue: No ]

Enrollment: 46
Study Start Date: April 2004
Study Completion Date: May 2009
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00053209

  Hide Study Locations
Locations
United States, Colorado
Aurora Presbyterian Hospital
Aurora, Colorado, United States, 80012
Boulder Community Hospital
Boulder, Colorado, United States, 80301
Penrose Cancer Center at Penrose Hospital
Colorado Springs, Colorado, United States, 80933
St. Joseph Hospital
Denver, Colorado, United States, 80218
Presbyterian - St. Luke's Medical Center
Denver, Colorado, United States, 80218
Porter Adventist Hospital
Denver, Colorado, United States, 80210
CCOP - Colorado Cancer Research Program, Incorporated
Denver, Colorado, United States, 80224-2522
Rose Medical Center
Denver, Colorado, United States, 80220
Swedish Medical Center
Englewood, Colorado, United States, 80110
Sky Ridge Medical Center
Lone Tree, Colorado, United States, 80124
Hope Cancer Care Center at Longmont United Hospital
Longmont, Colorado, United States, 80502
St. Mary-Corwin Regional Medical Center
Pueblo, Colorado, United States, 81004
North Suburban Medical Center
Thorton, Colorado, United States, 80229
United States, Connecticut
Yale Comprehensive Cancer Center at Yale University School of Medicine
New Haven, Connecticut, United States, 06520-8032
United States, Delaware
Beebe Medical Center
Lewes, Delaware, United States, 19958
CCOP - Christiana Care Health Services
Newark, Delaware, United States, 19718
St. Francis Hospital
Wilmington, Delaware, United States, 19805
United States, Florida
Baptist Cancer Institute - Jacksonville
Jacksonville, Florida, United States, 32207
Watson Clinic, LLC
Lakeland, Florida, United States, 33805
United States, Georgia
Hematology and Oncology of Northeast Georgia
Athens, Georgia, United States, 30607
MBCCOP-Medical College of Georgia Cancer Center
Augusta, Georgia, United States, 30912
United States, Illinois
Rush-Copley Cancer Care Center
Aurora, Illinois, United States, 60507
Hinsdale Hematology Oncology Associates
Hinsdale, Illinois, United States, 60521
Joliet Oncology Hematology Associates, Limited - West
Joliet, Illinois, United States, 60435
Regional Cancer Center at Memorial Medical Center
Springfield, Illinois, United States, 62781-0001
Carle Cancer Center at Carle Foundation Hospital
Urbana, Illinois, United States, 61801
CCOP - Carle Cancer Center
Urbana, Illinois, United States, 61801
United States, Indiana
Elkhart General Hospital
Elkhart, Indiana, United States, 46515
Center for Cancer Therapy at LaPorte Hospital and Health Services
La Porte, Indiana, United States, 46350
Saint Anthony Memorial Health Centers
Michigan City, Indiana, United States, 46360
Saint Joseph Regional Medical Center - Plymouth Campus
Plymouth, Indiana, United States, 46544
Memorial Hospital of South Bend
South Bend, Indiana, United States, 46601
CCOP - Northern Indiana CR Consortium
South Bend, Indiana, United States, 46601
United States, Iowa
McFarland Clinic, P.C.
Ames, Iowa, United States, 50010
St. Luke's Regional Medical Center
Sioux City, Iowa, United States, 51104
Siouxland Hematology-Oncology Associates
Sioux City, Iowa, United States, 51101
Siouxland Regional Cancer Center
Sioux City, Iowa, United States, 51101-1733
Mercy Medical Center - Sioux City
Sioux City, Iowa, United States, 51104
United States, Kansas
Cancer Center of Kansas - Chanute
Chanute, Kansas, United States, 66720
Cancer Center of Kansas - Dodge City
Dodge City, Kansas, United States, 67801
Cancer Center of Kansas, P.A. - El Dorado
El Dorado, Kansas, United States, 67042
Cancer Center of Kansas - Kingman
Kingman, Kansas, United States, 67068
Southwest Medical Center
Liberal, Kansas, United States, 67901
Cancer Center of Kansas - Newton
Newton, Kansas, United States, 67114
Cancer Center of Kansas, P.A. - Parsons
Parsons, Kansas, United States, 67357
Pratt Cancer Center of Kansas
Pratt, Kansas, United States, 67124
Cancer Center of Kansas - Salina
Salina, Kansas, United States, 67042
Cancer Center of Kansas - Wellington
Wellington, Kansas, United States, 67152
CCOP - Wichita
Wichita, Kansas, United States, 67214
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita, Kansas, United States, 67214
Associates in Womens Health
Wichita, Kansas, United States, 67203
Cancer Center of Kansas, P.A. - Wichita
Wichita, Kansas, United States, 67214
Cancer Center of Kansas, P.A.
Wichita, Kansas, United States, 67208
Cancer Center of Kansas - Winfield
Winfield, Kansas, United States, 67156
United States, Maryland
Union Hospital Cancer Center at Union Hospital
Elkton MD, Maryland, United States, 21921
United States, Michigan
Green Bay Oncology, Limited - Escanaba
Escanaba, Michigan, United States, 49431
Green Bay Oncology, Limited - Iron Mountain
Iron Mountain, Michigan, United States, 49801
Bronson Methodist Hospital
Kalamazoo, Michigan, United States, 49007
West Michigan Cancer Center
Kalamazoo, Michigan, United States, 49007
Borgess Medical Center
Kalamazooaa, Michigan, United States, 49001
United States, Minnesota
MeritCare Clinic - Bemidji
Bemidji, Minnesota, United States, 56601
Fairview Ridges Hospital
Burnsville, Minnesota, United States, 55337
Mercy and Unity Cancer Center at Mercy Hospital
Coon Rapids, Minnesota, United States, 55433
CCOP - Duluth
Duluth, Minnesota, United States, 55805
Miller-Dwan Medical Center
Duluth, Minnesota, United States, 55805
St. Mary's - Duluth Clinic Cancer Center
Duluth, Minnesota, United States, 55805
Fairview Southdale Hospital
Edina, Minnesota, United States, 55435
Mercy and Unity Cancer Center at Unity Hospital
Fridley, Minnesota, United States, 55432
Hutchinson Area Health Care
Hutchinson, Minnesota, United States, 55350
Meeker County Memorial Hospital
Litchfield, Minnesota, United States, 55355
St. John's Hospital
Maplewood, Minnesota, United States, 55109
Hennepin County Medical Center - Minneapolis
Minneapolis, Minnesota, United States, 55415
Virginia Piper Cancer Institute at Abbott-Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Hubert H. Humphrey Cancer Center at North Memorial Medical Center
Robbinsdale, Minnesota, United States, 55422
CCOP - Metro-Minnesota
Saint Louis Park, Minnesota, United States, 55416
Regions Hospital Cancer Care Center
Saint Paul, Minnesota, United States, 55101
Saint Francis Cancer Center
Shakopee, Minnesota, United States, 55379
St. Joseph's Hospital
St Paul, Minnesota, United States, 55102
Park Nicollet Health Services
St. Louis Park, Minnesota, United States, 55416
United Hospital
St. Paul, Minnesota, United States, 55102
Ridgeview Medical Center
Waconia, Minnesota, United States, 55387
Woodwinds Hospital
Woodbury, Minnesota, United States, 55125
United States, New Jersey
Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees
Camden, New Jersey, United States, 08103
Veterans Affairs Medical Center - East Orange
East Orange, New Jersey, United States, 07018-1095
CCOP - Northern New Jersey
Hackensack, New Jersey, United States, 07601
Cancer Institute of New Jersey at Hamilton
Hamilton, New Jersey, United States, 08690
Fox Chase Virtua Health Cancer Program - Marlton
Marlton, New Jersey, United States, 08053
Mountainside Hospital Cancer Center
Montclair, New Jersey, United States, 07042
Carol G. Simon Cancer Center at Morristown Memorial Hospital
Morristown, New Jersey, United States, 07962
Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08903
Overlook Hospital
Summit, New Jersey, United States, 07902
United States, New York
Our Lady of Mercy Medical Center Comprehensive Cancer Center
Bronx, New York, United States, 10466
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
MeritCare Medical Group
Fargo, North Dakota, United States, 58122
United States, Ohio
Aultman Hospital Cancer Center at Aultman Health Foundation
Canton, Ohio, United States, 44710
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, United States, 44195
Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University
Cleveland, Ohio, United States, 44106
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland, Ohio, United States, 44109
United States, Oklahoma
Natalie Warren Bryant Cancer Center at St. Francis Hospital
Tulsa, Oklahoma, United States, 74136
United States, Pennsylvania
St. Luke's Hospital Cancer Center
Bethlehem, Pennsylvania, United States, 18015
Central Pennsylvania Hematology and Medical Oncology Associates, P. C.
Lemoyne, Pennsylvania, United States, 17043
Fox Chase-Temple Cancer Center
Philadelphia, Pennsylvania, United States, 19111-2497
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Chester County Hospital
West Chester, Pennsylvania, United States, 19380
Reading Hospital and Medical Center
West Reading, Pennsylvania, United States, 19612
United States, South Carolina
Cancer Care Institute of Carolina at Aiken Regional Medical Centers
Aiken, South Carolina, United States, 29802
United States, South Dakota
Avera McKennan Hospital and University Health Center
Sioux Falls, South Dakota, United States, 57105
Medical X-Ray Center
Sioux Falls, South Dakota, United States, 57105
Sioux Valley Hospital and University of South Dakota Medical Center
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
Erlanger Cancer Center
Chattanooga, Tennessee, United States, 37403
Vanderbilt-Ingram Cancer Center
Nashville, Tennessee, United States, 37232
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
United States, Wisconsin
St. Mary's Hospital Medical Center
Green Bay, Wisconsin, United States, 54303
St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301
Green Bay Oncology, Limited at St. Mary's Hospital
Green Bay, Wisconsin, United States, 54303
Green Bay Oncology, Limited at St. Vincent Hospital
Green Bay, Wisconsin, United States, 54301-3526
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center
La Crosse, Wisconsin, United States, 54601
University of Wisconsin Comprehensive Cancer Center
Madison, Wisconsin, United States, 53792
Cancer Care Center at Holy Family Memorial Medical Center
Manitowoc, Wisconsin, United States, 54221
Green Bay Oncology, Limited - Oconto Falls
Oconto Falls, Wisconsin, United States, 54154
Green Bay Oncology, Limited - Sturgeon Bay
Sturgeon Bay, Wisconsin, United States, 54235
Sponsors and Collaborators
Eastern Cooperative Oncology Group
Investigators
Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
  More Information

Additional Information:
Publications:
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.

Responsible Party: Eastern Cooperative Oncology Group
ClinicalTrials.gov Identifier: NCT00053209     History of Changes
Other Study ID Numbers: CDR0000269302, ECOG-E4802
Study First Received: January 27, 2003
Last Updated: November 30, 2012
Health Authority: United States: Federal Government
United States: Food and Drug Administration

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
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Ureteral Diseases
Gemcitabine
Pemetrexed
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors

ClinicalTrials.gov processed this record on July 20, 2014