S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
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.
Transitional Cell Cancer of the Renal Pelvis and Ureter
Drug: gemcitabine hydrochloride
|Study Design:||Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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)|
- Study treatment feasibility [ Time Frame: monthly for duration of accrual ] [ Designated as safety issue: No ]
- Objective response rate (confirmed and unconfirmed complete and partial response) [ Time Frame: at weeks 10 and 19, then every 3 months for first year, and every 6 months for 3 years ] [ Designated as safety issue: No ]
- Survival at 2 years [ Time Frame: at weeks 10 and 19, then every 6 months for 2 years ] [ Designated as safety issue: No ]
- Toxicity and tolerability [ Time Frame: weeks 1-5, 7, 8, 10, 11, 13, 14, 16, 17, 19 ] [ Designated as safety issue: Yes ]
- Feasibility of standardized self-report measures of comorbidity, depression, and functional status [ Time Frame: upon completion of patient accrual ] [ Designated as safety issue: No ]
- Comparison of clinical pharmacologic parameters between elderly patients and patients under 60 years of age [ Time Frame: upon completion of patient accrual ] [ Designated as safety issue: No ]
|Study Start Date:||July 2001|
|Study Completion Date:||July 2011|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
|Experimental: gemcitabine, paclitaxel||
Drug: gemcitabine hydrochloride
Other Name: Taxol
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00022633
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|Study Chair:||Derek Raghavan, MD, PhD, FRACP, FACP||The Cleveland Clinic|