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

Phase 2
18 Years
Not Enrolling
Bladder Cancer, Transitional Cell Cancer of the Renal Pelvis and Ureter, Urethral Cancer

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Trial Information

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



- 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

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

Inclusion Criteria


- Histologically confirmed cancer of the urothelium (renal pelvis, ureter, bladder, or

- 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

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Response as measured by RECIST criteria

Outcome Time Frame:

Assessed every 6 weeks

Safety Issue:


Principal Investigator

Robert Dreicer, MD, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

April 2004

Completion Date:

May 2009

Related Keywords:

  • Bladder Cancer
  • Transitional Cell Cancer of the Renal Pelvis and Ureter
  • Urethral Cancer
  • 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
  • Urinary Bladder Neoplasms
  • Urethral Neoplasms
  • Carcinoma, Transitional Cell
  • Kidney Neoplasms
  • Ureteral Neoplasms



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