Bladder Cancer Clinical Trial
S0219, Combination Chemotherapy Followed By Observation or Surgery in Patients With Stage II or Stage III Cancer of the Urothelium
Summary
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells and decrease the need for surgery.
PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy followed by observation or surgery to remove the bladder (cystectomy) in treating patients who have stage II or stage III cancer of the urothelium.
Full Description
OBJECTIVES:
Determine the pathologic complete response of patients with stage II or III transitional cell cancer of the urothelium treated with neoadjuvant gemcitabine, paclitaxel, and carboplatin followed by observation or immediate cystectomy.
Determine, preliminarily, if molecular markers predict response, survival, and tumor recurrence in patients treated with these regimens.
Determine recurrence rates and cystectomy-free survival of patients who choose observation after an initial response to neoadjuvant chemotherapy.
Compare the survival of patients treated with neoadjuvant chemotherapy followed by cystectomy vs observation.
Determine the feasibility, tolerability, and toxicity of these regimens in these patients.
OUTLINE: This is a multicenter study.
Patients receive gemcitabine IV over 30 minutes and paclitaxel IV over 30 minutes on days 1 and 8 and carboplatin IV over 30 minutes on day 1. Treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity.
Within 4-8 weeks after completion of neoadjuvant chemotherapy, patients undergo a third transurethral resection of bladder tumor.
Patients with T0 disease after neoadjuvant chemotherapy may choose to undergo observation. These patients undergo cystoscopies with biopsies every 3 months for 1 year, every 4 months for 1 year, and then every 6 months until disease progression.
Patients with T1 disease or greater after neoadjuvant chemotherapy undergo immediate cystectomy. Patients with T0 disease may also choose this option. Patients undergoing immediate cystectomy are followed every 6 months for 2 years and then annually for 3 years.
PROJECTED ACCRUAL: A total of 95 patients will be accrued for this study within 2 years.
Eligibility Criteria
DISEASE CHARACTERISTICS:
Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) urothelial transitional cell cancer (TCC) of the bladder
Focal squamous and/or adenocarcinoma differentiation, defined as ≤ 10% of tumor volume allowed
The following diagnoses are not allowed:
Small cell carcinoma
Sarcomatoid components
Disease diagnosed with an initial transurethral resection of bladder tumor (TURBT) and a second TURBT performed within 8 weeks of first with attempt to remove all tumor present
Residual disease after second TURBT allowed
No more than 14-56 days after second TURBT
No metastatic disease by chest x-ray and CT scan or MRI of the abdomen and pelvis
Fresh tumor tissue, paraffin tumor tissue, unstained slides, or cell block specimen from one or both TURBTs available
PATIENT CHARACTERISTICS:
Age
18 and over
Performance status
Zubrod 0-2
Life expectancy
Not specified
Hematopoietic
White blood cell count (WBC) at least 3,500/mm^3
Absolute granulocyte count at least 1,500/mm^3
Platelet count at least lower limit of normal
Hepatic
Bilirubin no greater than 1.5 mg/dL
Aspartate aminotransferase (SGOT) no greater than 2 times upper limit of normal
Renal
Creatinine no greater than 2.0 mg/dL AND/OR
Creatinine clearance at least 60 mL/min
Other
No prohibitive medical risk that would preclude radical cystectomy
No other serious concurrent systemic disorder that would preclude study compliance
No other malignancy except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, adequately treated stage I or II cancer in complete remission, or any other cancer for which patient has been disease-free for 5 years
Not pregnant or nursing
Fertile patients must use effective contraception
PRIOR CONCURRENT THERAPY:
Biologic therapy
Prior intravesical immunotherapy allowed
Chemotherapy
No prior systemic chemotherapy for TCC of the urothelium
Prior intravesical chemotherapy allowed
Endocrine therapy
Not specified
Radiotherapy
No prior radiotherapy for TCC of the urothelium
No concurrent radiotherapy
Surgery
See Disease Characteristics
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There are 104 Locations for this study
Anchorage Alaska, 99519, United States
Glendale Arizona, 85306, United States
Mesa Arizona, 85202, United States
Mesa Arizona, 85206, United States
Phoenix Arizona, 85006, United States
Phoenix Arizona, 85006, United States
Burbank California, 91505, United States
Los Angeles California, 90089, United States
Sacramento California, 95817, United States
Aurora Colorado, 80045, United States
Denver Colorado, 80220, United States
Edwards Colorado, 81632, United States
Greeley Colorado, 80631, United States
Loveland Colorado, 80539, United States
Montrose Colorado, 81401, United States
Alton Illinois, 62002, United States
Decatur Illinois, 62526, United States
Mt. Vernon Illinois, 62864, 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
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
Lexington Kentucky, 40536, United States
Shreveport Louisiana, 71101, United States
Boston Massachusetts, 02118, United States
Ann Arbor Michigan, 48106, United States
Ann Arbor Michigan, 48106, 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
Dearborn Michigan, 48123, United States
Detroit Michigan, 48201, United States
Flint Michigan, 48503, United States
Flint Michigan, 48503, 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
Grosse Pointe Woods Michigan, 48236, United States
Holland Michigan, 49423, United States
Jackson Michigan, 49201, United States
Lansing Michigan, 48909, United States
Muskegon Michigan, 49443, United States
Saginaw Michigan, 48601, United States
Southfield Michigan, 48075, United States
Traverse City Michigan, 49684, United States
Warren Michigan, 48093, United States
Pascagoula Mississippi, 39581, United States
Cape Girardeau Missouri, 63701, United States
Gape Girardeau Missouri, 63701, United States
Saint Louis Missouri, 63141, United States
St. Louis Missouri, 63141, 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
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, 59807, United States
Missoula Montana, 59807, United States
Kearney Nebraska, 68848, United States
Glens Falls New York, 12801, 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
Winston-Salem North Carolina, 27103, United States
Gresham Oregon, 97030, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97210, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Portland Oregon, 97225, United States
Portland Oregon, 97227, United States
Tualatin Oregon, 97062, United States
Anderson South Carolina, 29621, United States
Spartanburg South Carolina, 29303, United States
Spartanburg South Carolina, 29303, United States
Memphis Tennessee, 38104, United States
Temple Texas, 76508, United States
American Fork Utah, 84003, United States
Logan Utah, 84321, United States
Murray Utah, 84107, United States
Ogden Utah, 84403, United States
Provo Utah, 84604, United States
Saint George Utah, 84770, United States
Salt Lake City Utah, 84106, United States
Salt Lake City Utah, 84143, 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
Vancouver Washington, 98668, United States
Wenatchee Washington, 98801, United States
Sheridan Wyoming, 82801, United States
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