Bladder Cancer Clinical Trial
Official title:
Protocol for Assessment of Gemcitabine and Paclitaxel for Metastatic Urothelial Cancer in Patients Aged 70 Years or Older (and in a Cohort of Patients Younger Than 60 Years)
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. Giving more than one drug may kill more tumor cells.
PURPOSE: Phase II trial to study the effectiveness of combining gemcitabine and paclitaxel
in treating patients who have advanced or recurrent cancer of the urinary tract.
OBJECTIVES:
- Determine the feasibility of enrolling patients aged 70 years and older with advanced
or recurrent urothelial cancer to a structured phase II study.
- Determine the anticancer efficacy of gemcitabine and paclitaxel, in terms of objective
response rate and 2-year survival, in these elderly patients.
- Assess the toxicity and tolerability of this regimen in these elderly patients.
- Determine the feasibility of using standardized self-report measures of comorbidity,
depression, and functional status in these patients.
- Determine the pharmacokinetics of this regimen in these elderly patients and validate
this data against similar parameters in patients aged under 60 years.
OUTLINE: This is a multicenter study. Patients are stratified according to age (70 and over
vs under 60).
Patients receive paclitaxel IV over 3 hours on day 1 and gemcitabine IV over 30 minutes on
days 1 and 8. Treatment repeats every 21 days for a maximum of 6 courses in the absence of
disease progression or unacceptable toxicity.
Quality of life is assessed at baseline.
Patients are followed every 3 months for 1 year and then every 6 months for 2 years.
PROJECTED ACCRUAL: A total of 80 patients (60 age 70 and over and 20 under age 60) will be
accrued for this study.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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