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.

View Full Description

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.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

77

Study ID:

NCT00045630

Recruitment Status:

Completed

Sponsor:

Southwest Oncology Group

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There are 104 Locations for this study

See Locations Near You

Cancer Center at Providence Alaska Medical Center
Anchorage Alaska, 99519, United States
Banner Thunderbird Medical Center
Glendale Arizona, 85306, United States
Banner Desert Medical Center
Mesa Arizona, 85202, United States
Banner Baywood Medical Center
Mesa Arizona, 85206, United States
Banner Good Samaritan Medical Center
Phoenix Arizona, 85006, United States
CCOP - Western Regional, Arizona
Phoenix Arizona, 85006, United States
Providence Saint Joseph Medical Center - Burbank
Burbank California, 91505, United States
USC/Norris Comprehensive Cancer Center and Hospital
Los Angeles California, 90089, United States
University of California Davis Cancer Center
Sacramento California, 95817, United States
University of Colorado Cancer Center at University of Colorado Health Sciences Center
Aurora Colorado, 80045, United States
Veterans Affairs Medical Center - Denver
Denver Colorado, 80220, United States
Shaw Cancer Center at Vail Valley Medical Center
Edwards Colorado, 81632, United States
North Colorado Medical Center
Greeley Colorado, 80631, United States
McKee Medical Center
Loveland Colorado, 80539, United States
Montrose Memorial Hospital Cancer Center
Montrose Colorado, 81401, United States
Saint Anthony's Hospital at Saint Anthony's Health Center
Alton Illinois, 62002, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
Good Samaritan Regional Health Center
Mt. Vernon Illinois, 62864, United States
Regional Cancer Center at Memorial Medical Center
Springfield Illinois, 62781, United States
Cancer Center of Kansas, PA - Chanute
Chanute Kansas, 66720, United States
Cancer Center of Kansas, PA - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas, PA - El Dorado
El Dorado Kansas, 67042, United States
Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Kansas City Kansas, 66160, United States
Cancer Center of Kansas, PA - Kingman
Kingman Kansas, 67068, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas, PA - Newton
Newton Kansas, 67114, United States
Cancer Center of Kansas, PA - Parsons
Parsons Kansas, 67357, United States
Cancer Center of Kansas, PA - Pratt
Pratt Kansas, 67124, United States
Cancer Center of Kansas, PA - Salina
Salina Kansas, 67042, United States
Tammy Walker Cancer Center at Salina Regional Health Center
Salina Kansas, 67401, United States
Cancer Center of Kansas, PA - Wellington
Wellington Kansas, 67152, United States
Associates in Womens Health, PA - North Review
Wichita Kansas, 67203, United States
Cancer Center of Kansas, PA - Medical Arts Tower
Wichita Kansas, 67208, United States
Cancer Center of Kansas, PA - Wichita
Wichita Kansas, 67214, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Via Christi Cancer Center at Via Christi Regional Medical Center
Wichita Kansas, 67214, United States
Cancer Center of Kansas, PA - Winfield
Winfield Kansas, 67156, United States
Markey Cancer Center at University of Kentucky Chandler Medical Center
Lexington Kentucky, 40536, United States
Christus Schumpert Cancer Treatment Center
Shreveport Louisiana, 71101, United States
Cancer Research Center at Boston Medical Center
Boston Massachusetts, 02118, United States
Saint Joseph Mercy Cancer Center
Ann Arbor Michigan, 48106, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Battle Creek Health System Cancer Care Center
Battle Creek Michigan, 49017, United States
Bay Regional Medical Center
Bay City Michigan, 48708, United States
Mecosta County Medical Center
Big Rapids Michigan, 49307, United States
Oakwood Cancer Center at Oakwood Hospital and Medical Center
Dearborn Michigan, 48123, United States
Barbara Ann Karmanos Cancer Institute
Detroit Michigan, 48201, United States
Genesys Hurley Cancer Institute
Flint Michigan, 48503, United States
Hurley Medical Center
Flint Michigan, 48503, United States
CCOP - Grand Rapids
Grand Rapids Michigan, 49503, United States
Lacks Cancer Center at Saint Mary's Health Care
Grand Rapids Michigan, 49503, United States
Spectrum Health Hospital - Butterworth Campus
Grand Rapids Michigan, 49503, United States
Metropolitan Hospital
Grand Rapids Michigan, 49506, United States
Van Elslander Cancer Center at St. John Hospital and Medical Center
Grosse Pointe Woods Michigan, 48236, United States
Holland Community Hospital
Holland Michigan, 49423, United States
Foote Hospital
Jackson Michigan, 49201, United States
Sparrow Regional Cancer Center
Lansing Michigan, 48909, United States
Hackley Hospital
Muskegon Michigan, 49443, United States
Seton Cancer Institute - Saginaw
Saginaw Michigan, 48601, United States
Providence Cancer Institute at Providence Hospital - Southfield Campus
Southfield Michigan, 48075, United States
Munson Medical Center
Traverse City Michigan, 49684, United States
St. John Macomb Hospital
Warren Michigan, 48093, United States
Regional Cancer Center at Singing River Hospital
Pascagoula Mississippi, 39581, United States
Saint Francis Medical Center
Cape Girardeau Missouri, 63701, United States
Southeast Missouri Regional Cancer Center at Southeast Missouri Hospital
Gape Girardeau Missouri, 63701, United States
David C. Pratt Cancer Center at St. John's Mercy
Saint Louis Missouri, 63141, United States
CCOP - St. Louis-Cape Girardeau
St. Louis Missouri, 63141, United States
CCOP - Montana Cancer Consortium
Billings Montana, 59101, United States
Hematology-Oncology Centers of the Northern Rockies - Billings
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
St. Vincent Healthcare
Billings Montana, 59101, United States
Deaconess Billings Clinic - Downtown
Billings Montana, 59107, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
St. James Community Hospital
Butte Montana, 59701, United States
Big Sky Oncology
Great Falls Montana, 59405, United States
Sletten Regional Cancer Institute at Benefis Healthcare
Great Falls Montana, 59405, United States

Great Falls Montana, 59405, United States
St. Peter's Hospital
Helena Montana, 59601, United States
Glacier Oncology, PLLC
Kalispell Montana, 59901, United States
Kalispell Medical Oncology
Kalispell Montana, 59901, United States
Kalispell Regional Medical Center
Kalispell Montana, 59901, United States
Community Medical Center
Missoula Montana, 59801, United States
Montana Cancer Specialists at Montana Cancer Center
Missoula Montana, 59807, United States
Montana Cancer Center at St. Patrick Hospital and Health Sciences Center
Missoula Montana, 59807, United States
Good Samaritan Cancer Center at Good Samaritan Hospital
Kearney Nebraska, 68848, United States
Adirondack Cancer Care - Glens Falls
Glens Falls New York, 12801, United States
Wayne Memorial Hospital, Incorporated
Goldsboro North Carolina, 27534, United States
Wayne Radiation Oncology
Goldsboro North Carolina, 27534, United States
Rutherford Hospital
Rutherfordton North Carolina, 28139, United States
Wilson Medical Center
Wilson North Carolina, 27893, United States
Forsyth Regional Cancer Center at Forsyth Medical Center
Winston-Salem North Carolina, 27103, United States
Legacy Mount Hood Medical Center
Gresham Oregon, 97030, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Legacy Good Samaritan Hospital & Medical Center Comprehensive Cancer Center
Portland Oregon, 97210, United States
Providence Cancer Center at Providence Portland Medical Center
Portland Oregon, 97213, United States
CCOP - Columbia River Oncology Program
Portland Oregon, 97225, United States
Providence St. Vincent Medical Center
Portland Oregon, 97225, United States
Legacy Emanuel Hospital and Health Center & Children's Hospital
Portland Oregon, 97227, United States
Legacy Meridian Park Hospital
Tualatin Oregon, 97062, United States
AnMed Health Cancer Center
Anderson South Carolina, 29621, United States
CCOP - Upstate Carolina
Spartanburg South Carolina, 29303, United States
Gibbs Regional Cancer Center at Spartanburg Regional Medical Center
Spartanburg South Carolina, 29303, United States
University of Tennessee Cancer Institute - Medical Center
Memphis Tennessee, 38104, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
American Fork Hospital
American Fork Utah, 84003, United States
Logan Regional Hospital
Logan Utah, 84321, United States
Cottonwood Hospital Medical Center
Murray Utah, 84107, United States
McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center - Provo
Provo Utah, 84604, United States
Dixie Regional Medical Center - East Campus
Saint George Utah, 84770, United States
Utah Cancer Specialists at UCS Cancer Center
Salt Lake City Utah, 84106, United States
Latter Day Saints Hospital
Salt Lake City Utah, 84143, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
St. Joseph Cancer Center
Bellingham Washington, 98225, United States
Olympic Hematology and Oncology
Bremerton Washington, 98310, United States
Skagit Valley Hospital Cancer Care Center
Mt. Vernon Washington, 98273, United States
Fred Hutchinson Cancer Research Center
Seattle Washington, 98104, United States
Harborview Medical Center
Seattle Washington, 98104, United States
Minor and James Medical, PLLC
Seattle Washington, 98104, United States
Swedish Cancer Institute at Swedish Medical Center - First Hill Campus
Seattle Washington, 98122, United States
Polyclinic First Hill
Seattle Washington, 98122, United States
University Cancer Center at University of Washington Medical Center
Seattle Washington, 98195, United States
North Puget Oncology at United General Hospital
Sedro-Wooley Washington, 98284, United States
Cancer Care Northwest - Spokane South
Spokane Washington, 99202, United States
Southwest Washington Medical Center Cancer Center
Vancouver Washington, 98668, United States
Wenatchee Valley Medical Center
Wenatchee Washington, 98801, United States
Welch Cancer Center at Sheridan Memorial Hospital
Sheridan Wyoming, 82801, United States

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 2

Estimated Enrollment:

77

Study ID:

NCT00045630

Recruitment Status:

Completed

Sponsor:


Southwest Oncology Group

How clear is this clinincal trial information?

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