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Bladder CancerPhase 2NCT00053209

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

A Phase 2 study testing gemcitabine hydrochloride and pemetrexed disodium in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Eastern Cooperative Oncology Group at 121 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 120 years
What is being tested?
gemcitabine hydrochloride and pemetrexed disodium
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
121 sitesUnited States
Study dates
10 Aug 2004to May 2009
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 120 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

121 sites in 1 country.

121 sites in 1 country

United States121 sites

  • Cancer Care Institute of Carolina at Aiken Regional Medical Centers

    Aiken, South Carolina, 29802

  • McFarland Clinic, P.C.

    Ames, Iowa, 50010

  • Hematology and Oncology of Northeast Georgia

    Athens, Georgia, 30607

  • MBCCOP-Medical College of Georgia Cancer Center

    Augusta, Georgia, 30912

  • Aurora Presbyterian Hospital

    Aurora, Colorado, 80012

  • Rush-Copley Cancer Care Center

    Aurora, Illinois, 60507

  • MeritCare Clinic - Bemidji

    Bemidji, Minnesota, 56601

  • St. Luke's Hospital Cancer Center

    Bethlehem, Pennsylvania, 18015

  • Boulder Community Hospital

    Boulder, Colorado, 80301

  • Fairview Ridges Hospital

    Burnsville, Minnesota, 55337

  • Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees

    Camden, New Jersey, 08103

  • Aultman Hospital Cancer Center at Aultman Health Foundation

    Canton, Ohio, 44710

  • Cancer Center of Kansas - Chanute

    Chanute, Kansas, 66720

  • Erlanger Cancer Center

    Chattanooga, Tennessee, 37403

  • Ireland Cancer Center at University Hospitals of Cleveland and Case Western Reserve University

    Cleveland, Ohio, 44106

  • MetroHealth's Cancer Care Center at MetroHealth Medical Center

    Cleveland, Ohio, 44109

  • Cleveland Clinic Taussig Cancer Center

    Cleveland, Ohio, 44195

  • Penrose Cancer Center at Penrose Hospital

    Colorado Springs, Colorado, 80933

  • Mercy and Unity Cancer Center at Mercy Hospital

    Coon Rapids, Minnesota, 55433

  • Porter Adventist Hospital

    Denver, Colorado, 80210

  • Presbyterian - St. Luke's Medical Center

    Denver, Colorado, 80218

  • St. Joseph Hospital

    Denver, Colorado, 80218

  • Rose Medical Center

    Denver, Colorado, 80220

  • CCOP - Colorado Cancer Research Program, Incorporated

    Denver, Colorado, 80224-2522

  • Cancer Center of Kansas - Dodge City

    Dodge City, Kansas, 67801

  • CCOP - Duluth

    Duluth, Minnesota, 55805

  • Miller-Dwan Medical Center

    Duluth, Minnesota, 55805

  • St. Mary's - Duluth Clinic Cancer Center

    Duluth, Minnesota, 55805

  • Veterans Affairs Medical Center - East Orange

    East Orange, New Jersey, 07018-1095

  • Fairview Southdale Hospital

    Edina, Minnesota, 55435

  • Cancer Center of Kansas, P.A. - El Dorado

    El Dorado, Kansas, 67042

  • Elkhart General Hospital

    Elkhart, Indiana, 46515

  • Union Hospital Cancer Center at Union Hospital

    Elkton, Maryland, 21921

  • Swedish Medical Center

    Englewood, Colorado, 80110

  • Green Bay Oncology, Limited - Escanaba

    Escanaba, Michigan, 49431

  • CCOP - MeritCare Hospital

    Fargo, North Dakota, 58122

  • MeritCare Medical Group

    Fargo, North Dakota, 58122

  • Mercy and Unity Cancer Center at Unity Hospital

    Fridley, Minnesota, 55432

  • Green Bay Oncology, Limited at St. Vincent Hospital

    Green Bay, Wisconsin, 54301-3526

  • St. Vincent Hospital

    Green Bay, Wisconsin, 54301

  • Green Bay Oncology, Limited at St. Mary's Hospital

    Green Bay, Wisconsin, 54303

  • St. Mary's Hospital Medical Center

    Green Bay, Wisconsin, 54303

  • CCOP - Northern New Jersey

    Hackensack, New Jersey, 07601

  • Cancer Institute of New Jersey at Hamilton

    Hamilton, New Jersey, 08690

  • Hinsdale Hematology Oncology Associates

    Hinsdale, Illinois, 60521

  • Hutchinson Area Health Care

    Hutchinson, Minnesota, 55350

  • Green Bay Oncology, Limited - Iron Mountain

    Iron Mountain, Michigan, 49801

  • Baptist Cancer Institute - Jacksonville

    Jacksonville, Florida, 32207

  • Joliet Oncology Hematology Associates, Limited - West

    Joliet, Illinois, 60435

  • Borgess Medical Center

    Kalamazoo, Michigan, 49001

  • Bronson Methodist Hospital

    Kalamazoo, Michigan, 49007

  • West Michigan Cancer Center

    Kalamazoo, Michigan, 49007

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical Center

    La Crosse, Wisconsin, 54601

  • Center for Cancer Therapy at LaPorte Hospital and Health Services

    La Porte, Indiana, 46350

  • Watson Clinic, LLC

    Lakeland, Florida, 33805

  • Central Pennsylvania Hematology and Medical Oncology Associates, P. C.

    Lemoyne, Pennsylvania, 17043

  • Beebe Medical Center

    Lewes, Delaware, 19958

  • Southwest Medical Center

    Liberal, Kansas, 67901

  • Meeker County Memorial Hospital

    Litchfield, Minnesota, 55355

  • Sky Ridge Medical Center

    Lone Tree, Colorado, 80124

  • Hope Cancer Care Center at Longmont United Hospital

    Longmont, Colorado, 80502

  • University of Wisconsin Comprehensive Cancer Center

    Madison, Wisconsin, 53792

  • Cancer Care Center at Holy Family Memorial Medical Center

    Manitowoc, Wisconsin, 54221

  • St. John's Hospital

    Maplewood, Minnesota, 55109

  • Fox Chase Virtua Health Cancer Program - Marlton

    Marlton, New Jersey, 08053

  • Saint Anthony Memorial Health Centers

    Michigan City, Indiana, 46360

  • Virginia Piper Cancer Institute at Abbott-Northwestern Hospital

    Minneapolis, Minnesota, 55407

  • Hennepin County Medical Center - Minneapolis

    Minneapolis, Minnesota, 55415

  • Mountainside Hospital Cancer Center

    Montclair, New Jersey, 07042

  • Carol G. Simon Cancer Center at Morristown Memorial Hospital

    Morristown, New Jersey, 07962

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 37232

  • Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School

    New Brunswick, New Jersey, 08903

  • Yale Comprehensive Cancer Center at Yale University School of Medicine

    New Haven, Connecticut, 06520-8032

  • CCOP - Christiana Care Health Services

    Newark, Delaware, 19718

  • Cancer Center of Kansas - Newton

    Newton, Kansas, 67114

  • Green Bay Oncology, Limited - Oconto Falls

    Oconto Falls, Wisconsin, 54154

  • Cancer Center of Kansas, P.A. - Parsons

    Parsons, Kansas, 67357

  • Abramson Cancer Center of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Fox Chase-Temple Cancer Center

    Philadelphia, Pennsylvania, 19111-2497

  • Saint Joseph Regional Medical Center - Plymouth Campus

    Plymouth, Indiana, 46544

  • Pratt Cancer Center of Kansas

    Pratt, Kansas, 67124

  • St. Mary-Corwin Regional Medical Center

    Pueblo, Colorado, 81004

  • Hubert H. Humphrey Cancer Center at North Memorial Medical Center

    Robbinsdale, Minnesota, 55422

  • CCOP - Metro-Minnesota

    Saint Louis Park, Minnesota, 55416

  • Park Nicollet Health Services

    Saint Louis Park, Minnesota, 55416

  • Regions Hospital Cancer Care Center

    Saint Paul, Minnesota, 55101

  • St. Joseph's Hospital

    Saint Paul, Minnesota, 55102

  • United Hospital

    Saint Paul, Minnesota, 55102

  • Cancer Center of Kansas - Salina

    Salina, Kansas, 67042

  • Saint Francis Cancer Center

    Shakopee, Minnesota, 55379

  • Siouxland Regional Cancer Center

    Sioux City, Iowa, 51101-1733

  • Siouxland Hematology-Oncology Associates

    Sioux City, Iowa, 51101

  • Mercy Medical Center - Sioux City

    Sioux City, Iowa, 51104

  • St. Luke's Regional Medical Center

    Sioux City, Iowa, 51104

  • Sioux Valley Hospital and University of South Dakota Medical Center

    Sioux Falls, South Dakota, 57104

  • Avera McKennan Hospital and University Health Center

    Sioux Falls, South Dakota, 57105

  • Medical X-Ray Center

    Sioux Falls, South Dakota, 57105

  • CCOP - Northern Indiana CR Consortium

    South Bend, Indiana, 46601

  • Memorial Hospital of South Bend

    South Bend, Indiana, 46601

  • Regional Cancer Center at Memorial Medical Center

    Springfield, Illinois, 62781-0001

  • Green Bay Oncology, Limited - Sturgeon Bay

    Sturgeon Bay, Wisconsin, 54235

  • Overlook Hospital

    Summit, New Jersey, 07902

  • CCOP - Scott and White Hospital

    Temple, Texas, 76508

  • Our Lady of Mercy Medical Center Comprehensive Cancer Center

    The Bronx, New York, 10466

  • North Suburban Medical Center

    Thornton, Colorado, 80229

  • Natalie Warren Bryant Cancer Center at St. Francis Hospital

    Tulsa, Oklahoma, 74136

  • Carle Cancer Center at Carle Foundation Hospital

    Urbana, Illinois, 61801

  • CCOP - Carle Cancer Center

    Urbana, Illinois, 61801

  • Ridgeview Medical Center

    Waconia, Minnesota, 55387

  • Cancer Center of Kansas - Wellington

    Wellington, Kansas, 67152

  • Chester County Hospital

    West Chester, Pennsylvania, 19380

  • Reading Hospital and Medical Center

    West Reading, Pennsylvania, 19612

  • Associates in Womens Health

    Wichita, Kansas, 67203

  • Cancer Center of Kansas, P.A.

    Wichita, Kansas, 67208

  • Cancer Center of Kansas, P.A. - Wichita

    Wichita, Kansas, 67214

  • CCOP - Wichita

    Wichita, Kansas, 67214

  • Via Christi Cancer Center at Via Christi Regional Medical Center

    Wichita, Kansas, 67214

  • St. Francis Hospital

    Wilmington, Delaware, 19805

  • Cancer Center of Kansas - Winfield

    Winfield, Kansas, 67156

  • Woodwinds Hospital

    Woodbury, Minnesota, 55125

Other trials in United States

About this study

Official title: Phase II Trial Of Pemetrexed Disodium And Gemcitabine In Advanced Urothelial Cancer

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.

Read the 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.

Being tested
gemcitabine hydrochloride, pemetrexed disodium
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
Medical subject headings
Urinary Bladder Neoplasms, Urethral Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00053209
Study groupRoleWhat they receive
Pemetrexed Disodium and GemcitabineExperimentalPemetrexed 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
Receives: Drug: gemcitabine hydrochloride; Drug: pemetrexed disodium

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Response as measured by RECIST criteria

    Measured: Assessed every 6 weeks

Secondary outcomes (2)

  1. Time to disease progression

    Measured: Assessed every 6 weeks

  2. Overall survival

    Measured: Assessed every 3 months for 2 years, then every 6 months for 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jan 2003 (estimated)
  2. Study start10 Aug 2004
  3. Primary completionSep 2007
  4. Study completionMay 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00053209
Sponsor's protocol ID
CDR0000269302
Other IDs
ECOG-E4802
Status last verified
Jun 2023
First submitted
27 Jan 2003
Last updated
22 Jun 2023
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 18459175

  • 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.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing gemcitabine hydrochloride and pemetrexed disodium in people with Bladder Cancer and Transitional Cell Cancer of the Renal Pelvis and Ureter, run by Eastern Cooperative Oncology Group at 121 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 121 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Response as measured by RECIST criteria (time frame: Assessed every 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00053209, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jun 2023.

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