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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

January 27, 2003
November 30, 2012
April 2004
September 2007   (final data collection date for primary outcome measure)
Response as measured by RECIST criteria [ Time Frame: Assessed every 6 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00053209 on ClinicalTrials.gov Archive Site
  • 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 ]
Not Provided
Not Provided
Not Provided
 
Pemetrexed Disodium and Gemcitabine in Treating Patients With Advanced Cancer of the Urothelium
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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • Drug: gemcitabine hydrochloride
  • Drug: pemetrexed disodium
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
Interventions:
  • Drug: gemcitabine hydrochloride
  • Drug: pemetrexed disodium

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
46
May 2009
September 2007   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00053209
CDR0000269302, ECOG-E4802
No
Eastern Cooperative Oncology Group
Eastern Cooperative Oncology Group
National Cancer Institute (NCI)
Study Chair: Robert Dreicer, MD, FACP The Cleveland Clinic
Eastern Cooperative Oncology Group
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP