Conditions: Bladder Cancer Transitional Cell Cancer of the Renal Pelvis and Ureter Urethral Cancer
Keywords: recurrent bladder cancer stage IV bladder cancer transitional cell carcinoma of the bladder squamous cell carcinoma of the bladder adenocarcinoma of the bladder recurrent urethral cancer anterior urethral cancer posterior urethral cancer urethral cancer associated with invasive bladder cancer metastatic transitional cell cancer of the renal pelvis and ureter regional transitional cell cancer of the renal pelvis and ureter recurrent transitional cell cancer of the renal pelvis and ureter
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 65
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: None

Interventions: intervention 1: gemcitabine hydrochloride intervention 2: paclitaxel
Intervention descriptions: intervention 1: None intervention 2: None

Protocol document: