Bladder Cancer Clinical Trial
S0028, Gemcitabine and Paclitaxel in Treating Patients With Advanced or Recurrent Cancer of the Urinary Tract
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.
Full 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.
Eligibility Criteria
DISEASE CHARACTERISTICS:
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
PATIENT CHARACTERISTICS:
Age:
70 and over OR
Under 60
Performance status:
Zubrod 0-2
Life expectancy:
Not specified
Hematopoietic:
Absolute granulocyte count at least 1,200/mm^3
Platelet count at least 100,000/mm^3
Hepatic:
Bilirubin no greater than upper limit of normal (ULN)
Aspartate aminotransferase (SGOT) or alanine aminotransferase (SGPT) no greater than 2 times ULN
Renal:
Creatinine no greater than ULN
Other:
HIV negative
No other concurrent life-threatening medical disorder that would preclude study participation
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
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Not specified
Chemotherapy:
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
Radiotherapy:
See Disease Characteristics
At least 28 days since prior radiotherapy and recovered
Surgery:
See Disease Characteristics
At least 28 days since prior surgery and recovered
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There are 73 Locations for this study
Mobile Alabama, 36652, United States
Little Rock Arkansas, 72205, United States
Los Angeles California, 90089, United States
Valdosta Georgia, 31603, United States
Springfield Illinois, 62781, United States
Chanute Kansas, 66720, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kansas City Kansas, 66160, United States
Kingman Kansas, 67068, United States
Liberal Kansas, 67901, United States
Newton Kansas, 67114, United States
Parsons Kansas, 67357, United States
Pratt Kansas, 67124, United States
Salina Kansas, 67042, United States
Salina Kansas, 67401, United States
Topeka Kansas, 66604, United States
Topeka Kansas, 66606, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67203, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Wichita Kansas, 67214, United States
Winfield Kansas, 67156, United States
Ann Arbor Michigan, 48109, United States
Battle Creek Michigan, 49017, United States
Bay City Michigan, 48708, United States
Big Rapids Michigan, 49307, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49503, United States
Grand Rapids Michigan, 49506, United States
Holland Michigan, 49423, United States
Muskegon Michigan, 49443, United States
Port Huron Michigan, 48060, United States
Traverse City Michigan, 49684, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59107, United States
Bozeman Montana, 59715, United States
Butte Montana, 59701, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Helena Montana, 59601, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Kalispell Montana, 59901, United States
Missoula Montana, 59801, United States
Missoula Montana, 59804, United States
Missoula Montana, 59807, United States
Missoula Montana, 59807, United States
Kearney Nebraska, 68848, United States
Clifton Springs New York, 14432, United States
Middletown New York, 10940, United States
Rochester New York, 14623, United States
Rochester New York, 14642, United States
Goldsboro North Carolina, 27534, United States
Goldsboro North Carolina, 27534, United States
Rutherfordton North Carolina, 28139, United States
Wilson North Carolina, 27893, United States
Akron Ohio, 44307, United States
Cleveland Ohio, 44195, United States
Independence Ohio, 44131, United States
Wooster Ohio, 44691, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Dallas Texas, 75230, United States
Fort Sam Houston Texas, 78234, United States
Lackland AFB Texas, 78236, United States
San Antonio Texas, 78209, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
San Antonio Texas, 78229, United States
Temple Texas, 76508, United States
Danville Virginia, 24541, United States
Bellingham Washington, 98225, United States
Bremerton Washington, 98310, United States
Mt. Vernon Washington, 98273, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98104, United States
Seattle Washington, 98122, United States
Seattle Washington, 98122, United States
Seattle Washington, 98195, United States
Sedro-Wooley Washington, 98284, United States
Spokane Washington, 99202, United States
Wenatchee Washington, 98801, United States
Sheridan Wyoming, 82801, United States
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