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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)

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

Thank you

Trial Information

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)


- 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.

Inclusion Criteria


- Histologically confirmed urothelial cancer

- Transitional cell carcinoma, adenocarcinoma, or squamous carcinoma (bladder,
renal pelvis, ureter, or urethra)

- Previously untreated metastatic or locoregionally advanced (i.e., bulky pelvic nodes)
disease OR

- Locally recurrent carcinoma after radiotherapy or cystectomy and no longer eligible
for further radiotherapy or surgery

- Measurable disease



- 70 and over OR

- Under 60

Performance status:

- Zubrod 0-2

Life expectancy:

- Not specified


- Absolute granulocyte count at least 1,200/mm^3

- Platelet count at least 100,000/mm^3


- Bilirubin no greater than upper limit of normal (ULN)

- SGOT or SGPT no greater than 2 times ULN


- Creatinine no greater than ULN


- HIV negative

- No other concurrent life-threatening medical disorder that would preclude study

- No other prior malignancy within the past 5 years except adequately treated basal
cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately
treated stage I or II cancer in complete remission

- Not pregnant or nursing

- Fertile patients must use effective contraception


Biologic therapy:

- Not specified


- Prior adjuvant chemotherapy is allowed provided administered more than 10 years ago

- No prior gemcitabine, taxanes, or platinum-based adjuvant chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics

- At least 28 days since prior radiotherapy and recovered


- See Disease Characteristics

- At least 28 days since prior surgery and recovered

Type of Study:


Study Design:

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

Outcome Measure:

Study treatment feasibility

Outcome Time Frame:

monthly for duration of accrual

Safety Issue:


Principal Investigator

Derek Raghavan, MD, PhD, FRACP, FACP

Investigator Role:

Study Chair

Investigator Affiliation:

The Cleveland Clinic


United States: Federal Government

Study ID:




Start Date:

July 2001

Completion Date:

July 2011

Related Keywords:

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



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