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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00053209
Recruitment Status : Completed
First Posted : January 28, 2003
Last Update Posted : December 4, 2012
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Eastern Cooperative Oncology Group

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

Detailed Description:



  • 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.


  • 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.

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Study Type : Interventional  (Clinical Trial)
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 : April 2004
Actual Primary Completion Date : September 2007
Actual Study Completion Date : May 2009

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

Primary Outcome Measures :
  1. Response as measured by RECIST criteria [ Time Frame: Assessed every 6 weeks ]

Secondary Outcome Measures :
  1. Time to disease progression [ Time Frame: Assessed every 6 weeks ]
  2. Overall survival [ Time Frame: Assessed every 3 months for 2 years, then every 6 months for 3 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • 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)



  • 18 and over

Performance status

  • ECOG 0-2

Life expectancy

  • Not specified


  • Granulocyte count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3
  • Hemoglobin at least 9 g/dL


  • AST no greater than 3 times upper limit of normal (ULN)
  • Bilirubin no greater than 1.5 times ULN


  • Creatinine clearance at least 45 mL/min


  • 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


  • 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


Biologic therapy

  • No prior systemic biologic response modifier therapy


  • No prior systemic chemotherapy for metastatic disease
  • More than 1 year since prior neoadjuvant or adjuvant chemotherapy

Endocrine therapy

  • Not specified


  • At least 4 weeks since prior radiotherapy and recovered
  • No prior pelvic radiotherapy
  • No concurrent radiotherapy


  • At least 4 weeks since prior major surgery and recovered


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00053209

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Sponsors and Collaborators
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
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Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
Publications of Results:
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.

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Responsible Party: Eastern Cooperative Oncology Group Identifier: NCT00053209    
Other Study ID Numbers: CDR0000269302
First Posted: January 28, 2003    Key Record Dates
Last Update Posted: December 4, 2012
Last Verified: November 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:
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Urinary Bladder Neoplasms
Urethral Neoplasms
Carcinoma, Transitional Cell
Kidney Neoplasms
Ureteral Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Urinary Bladder Diseases
Urologic Diseases
Urethral Diseases
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Kidney Diseases
Ureteral Diseases
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Folic Acid Antagonists