Finding studies
Finding studies
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Lead
SWOG Cancer Research Network
With
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.
Age
0–120
Sex
ALL
Healthy volunteers
Not accepted