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Home > "C" Clinical Trials Conditions > Combination Chemotherapy Followed By Observation or Surgery in Treating Patients With Stage II or Stage III Cancer of the Urothelium

Combination Chemotherapy Followed By Observation or Surgery in Treating Patients With Stage II or Stage III Cancer of the Urothelium



Combination Chemotherapy Followed By Observation or Surgery in Treating Patients With Stage II or Stage III Cancer of the Urothelium

For Condition: Bladder Cancer,Urethral Cancer,transitional cell cancer of the renal pelvis and ureter
Status: Recruiting
Sponsor(s): Southwest Oncology Group , National Cancer Institute (NCI)
Synopsis: 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.
Details: 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:
Study Type:
  Interventional, Treatment
Minimum Age/Maximum Age: 18 Years/
Genders: Both
Protocol Entry Criteria: DISEASE CHARACTERISTICS: - Histologically confirmed muscle-invasive (T2-T4a), node-negative (N0) transitional cell cancer (TCC) of the urothelium (bladder, renal pelvis, ureter, or urethra) - No adenocarcinoma, small cell carcinoma, sarcomas, squamous cell carcinoma, or mixed histology - 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 PATIENT CHARACTERISTICS: Age - 18 and over Performance status - Zubrod 0-2 Life expectancy - Not specified Hematopoietic - 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 - SGOT no greater than 2 times upper limit of normal Renal - Creatinine no greater than 2.0 mg/dL - 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, 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
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
PrimoLara,  Study Chair,  University of California Davis Cancer Center

Veterans Affairs Medical Center - Dayton *Recruiting*
Dayton,  Ohio,  45428-1002
United States
Recruiting Howard  Gross 937-268-6511

Cancer Institute at Oregon Health and Science University *Recruiting*
Portland,  Oregon,  97201-3098
United States
Recruiting Craig  Nichols 503-494-6346

Baylor College of Medicine *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Seth  Lerner 713-798-5906

CCOP - Santa Rosa Memorial Hospital *Recruiting*
Santa Rosa,  California,  95403
United States
Recruiting Ian  Anderson 707-521-3859

Veterans Affairs Medical Center - Cincinnati *Recruiting*
Cincinnati,  Ohio,  45220-2288
United States
Recruiting Abdul-Rahman  Jazieh 513-861-3100 ext. 6537

Veterans Affairs Medical Center - Phoenix (Carl T. Hayden) *Recruiting*
Phoenix,  Arizona,  85012
United States
Recruiting Thomas  Kummet 602-277-5551

Veterans Affairs Outpatient Clinic - Martinez *Recruiting*
Martinez,  California,  94553
United States
Recruiting David  Gandara 925-372-2064

Veterans Affairs Medical Center - Oklahoma City *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-270-0501

University of Texas Health Science Center at San Antonio *Recruiting*
San Antonio,  Texas,  78229-3900
United States
Recruiting Geoffrey  Weiss 210-617-5120

CCOP - Wichita *Recruiting*
Wichita,  Kansas,  67214-3882
United States
Recruiting Shaker  Dakhil 316-268-5784

Veterans Affairs Medical Center - Houston *Recruiting*
Houston,  Texas,  77030
United States
Recruiting Gauri  Varadhachary 713-791-1414 ext. 5340

Oklahoma University Medical Center at University of Oklahoma Health Sciences Center *Recruiting*
Oklahoma City,  Oklahoma,  73104
United States
Recruiting Howard  Ozer 405-271-4022

City of Hope Comprehensive Cancer Center *Recruiting*
Duarte,  California,  91010-0269
United States
Recruiting Kim  Margolin 626-359-8111

University of California Davis Cancer Center *Recruiting*
Sacramento,  California,  95817
United States
Recruiting David  Gandara 916-734-3772

CCOP - Virginia Mason Research Center *Recruiting*
Seattle,  Washington,  98101
United States
Recruiting Andrew  Jacobs 206-341-0446

Veterans Affairs Medical Center - Seattle *Recruiting*
Seattle,  Washington,  98108
United States
Recruiting William  Schubach 206-764-2265

Veterans Affairs Medical Center - Albuquerque *Recruiting*
Albuquerque,  New Mexico,  87108-5138
United States
Recruiting Douglas  Clark 505-243-4039

Veterans Affairs Medical Center - Biloxi *Recruiting*
Biloxi,  Mississippi,  39531-2410
United States
Recruiting Robert  Veith 504-568-5151

MBCCOP - University of Illinois at Chicago *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Lawrence  Feldman 312-335-3614

Tulane University School of Medicine *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-587-7566

Cancer Research Center at Boston Medical Center *Recruiting*
Boston,  Massachusetts,  02118
United States
Recruiting Douglas  Faller 617-638-8000

CCOP - Columbus *Recruiting*
Columbus,  Ohio,  43206
United States
Recruiting J.  Kuebler 614-488-2118

Veterans Affairs Medical Center - Little Rock (McClellan) *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Bart  Barlogie 501-526-2873

Veterans Affairs Medical Center - Wichita *Recruiting*
Wichita,  Kansas,  67218
United States
Recruiting Shaker  Dakhil 316-685-2221

Barbara Ann Karmanos Cancer Institute *Recruiting*
Detroit,  Michigan,  48201-1379
United States
Recruiting Lawrence  Flaherty 313-745-9155

CCOP - Kansas City *Recruiting*
Kansas City,  Missouri,  64131
United States
Recruiting Jorge  Paradelo 816-823-0555

MBCCOP - Gulf Coast *Recruiting*
Mobile,  Alabama,  36607
United States
Recruiting Paul  Schwarzenberger 251-544-1013

University of Texas Medical Branch *Recruiting*
Galveston,  Texas,  77555-0565
United States
Recruiting Robert  Whitehead 409-772-1164

Veterans Affairs Medical Center - Ann Arbor *Recruiting*
Ann Arbor,  Michigan,  48105
United States
Recruiting Laurence  Baker 734-769-7100

MBCCOP - Howard University Cancer Center *Recruiting*
Washington D.C.,  District of Columbia,  20060
United States
Recruiting Lucile  Adams-Campbell 202-806-7697

CCOP - Columbia River Oncology Program *Recruiting*
Portland,  Oregon,  97225
United States
Recruiting Keith  Lanier 503-216-6260

Veterans Affairs Medical Center - Detroit *Recruiting*
Detroit,  Michigan,  48201-1932
United States
Recruiting Lawrence  Flaherty 313-576-1000

CCOP - Bay Area Tumor Institute *Recruiting*
Oakland,  California,  94609-3305
United States
Recruiting Joseph  Szumowski 510-465-8570

Louisiana State University Health Sciences Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130-3932
United States
Recruiting Glenn  Mills 318-675-7639

James P. Wilmot Cancer Center at University of Rochester Medical Center *Recruiting*
Rochester,  New York,  14642
United States
Recruiting Richard  Fisher 585-275-0842

CCOP - Northwest *Recruiting*
Tacoma,  Washington,  98405-0986
United States
Recruiting Lauren  Colman 253-403-1461

Danville Radiation Therapy Center *Recruiting*
Memphis,  Tennessee,  38104
United States
Recruiting Mohammad  Jahanzeb 901-523-8990

Southwest Cancer Center at UMC *Recruiting*
Lubbock,  Texas,  79415-3364
United States
Recruiting Werner  W. DeRiese 806-775-8590

CCOP - Beaumont *Recruiting*
Royal Oak,  Michigan,  48073-6769
United States
Recruiting David  Decker 248-551-7695

CCOP - Upstate Carolina *Recruiting*
Spartanburg,  South Carolina,  29303
United States
Recruiting James  Bearden 864-560-7050

Eastern Virginia Medical School *Recruiting*
Norfolk,  Virginia,  23510-1115
United States
Recruiting Paul  Schellhammer 804-628-2409

Harrington Cancer Center *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting James  Clarkson 806-359-4673

University of Colorado Cancer Center at University of Colorado Health Sciences Center *Recruiting*
Aurora,  Colorado,  80010
United States
Recruiting Anthony  Elias 720-848-1622

Veterans Affairs Medical Center - Kansas City *Recruiting*
Kansas City,  Missouri,  64128
United States
Recruiting Sarah  Taylor 816-861-4700 ext. 491

Charles M. Barrett Cancer Center at University Hospital *Recruiting*
Cincinnati,  Ohio,  45267-0501
United States
Recruiting Abdul-Rahman  Jazieh 513-584-3830

Brooke Army Medical Center *Recruiting*
Fort Sam Houston,  Texas,  78234-6200
United States
Recruiting Mitchell  Garrison 210-916-0504

Cardinal Bernardin Cancer Center at Loyola University Medical Center *Recruiting*
Maywood,  Illinois,  60153-5500
United States
Recruiting Patrick  Stiff 708-327-3148

CCOP - Southeast Cancer Control Consortium *Recruiting*
Winston Salem,  North Carolina,  27104-4241
United States
Recruiting James  Atkins 336-777-3036

Madigan Army Medical Center *Recruiting*
Tacoma,  Washington,  98431-5000
United States
Recruiting Rajat  Bannerji 253-968-2504

Herbert Irving Comprehensive Cancer Center at Columbia University *Recruiting*
New York City,  New York,  10032
United States
Recruiting Daniel  Petrylak 212-305-1731

Veterans Affairs Medical Center - Salt Lake City *Recruiting*
Salt Lake City,  Utah,  84148
United States
Recruiting Wolfram  Samlowski 801-582-1565

Veterans Affairs Medical Center - Temple *Recruiting*
Temple,  Texas,  76504
United States
Recruiting Phalguni  Mukhopadhyay 254-778-4811 ext. 4809

MBCCOP - University of New Mexico HSC *Recruiting*
Albuquerque,  New Mexico,  87131
United States
Recruiting Cheryl  Willman 505-272-5837

Veterans Affairs Medical Center - Lexington *Recruiting*
Lexington,  Kentucky,  40502-2236
United States
Recruiting Michael  Doukas 859-281-4956

CCOP - Montana Cancer Consortium *Recruiting*
Billings,  Montana,  59101
United States
Recruiting Patrick  Cobb 406-259-2245

Josephine Ford Cancer Center at Henry Ford Hospital *Recruiting*
Detroit,  Michigan,  48202
United States
Recruiting Robert  Chapman 313-916-1850

University of Arkansas for Medical Sciences *Recruiting*
Little Rock,  Arkansas,  72205
United States
Recruiting Laura  Hutchins 501-686-8511

Markey Cancer Center at University of Kentucky Chandler Medical Center *Recruiting*
Lexington,  Kentucky,  40536-0084
United States
Recruiting Michael  Doukas 859-257-4500

Jonsson Comprehensive Cancer Center, UCLA *Recruiting*
Los Angeles,  California,  90095-1781
United States
Recruiting John  Barstis 310-825-5268

MBCCOP - Massey Cancer Center *Recruiting*
Richmond,  Virginia,  23298-0037
United States
Recruiting John  Roberts 804-828-0450

University of Tennessee Cancer Institute *Recruiting*
Memphis,  Tennessee,  38103
United States
Recruiting Mohammad  Jahanzeb 901-722-0532

CCOP - Atlanta Regional *Recruiting*
Atlanta,  Georgia,  30342-1701
United States
Recruiting Thomas  Seay 404-851-2340

Veterans Affairs Medical Center - Hines (Hines Junior VA Hospital) *Recruiting*
Hines,  Illinois,  60141
United States
Recruiting Nirmala  Bhoopalam 708-202-2782

Kansas Cancer Institute at the University of Kansas Medical Center *Recruiting*
Kansas City,  Kansas,  66160-7390
United States
Recruiting James  Thrasher 913-588-6152

Veterans Affairs Medical Center - Shreveport *Recruiting*
Shreveport,  Louisiana,  71130
United States
Recruiting Glenn  Mills 318-221-8411

CCOP - Cancer Research for the Ozarks *Recruiting*
Springfield,  Missouri,  65807
United States
Recruiting John  Goodwin 417-269-4520

Chao Family Comprehensive Cancer Center at University of California Irvine Cancer Center *Recruiting*
Orange,  California,  92868
United States
Recruiting Randall  Holcombe 714-456-5153

Arizona Cancer Center at University of Arizona Health Sciences Center *Recruiting*
Tucson,  Arizona,  85724
United States
Recruiting Thomas  Miller 520-626-2667

Cleveland Clinic Taussig Cancer Center *Recruiting*
Cleveland,  Ohio,  44195-9001
United States
Recruiting George  Budd 216-444-6480

Veterans Affairs Medical Center - San Antonio (Murphy) *Recruiting*
San Antonio,  Texas,  78229
United States
Recruiting Geoffrey  Weiss 210-617-5120

CCOP - Greenville *Recruiting*
Greenville,  South Carolina,  29615
United States
Recruiting Jeffrey  Giguere 864-241-6251

Providence Cancer Institute at Providence Hospital *Recruiting*
Southfield,  Michigan,  48075
United States
Recruiting Anibal  Drelichman 313-552-0620

Veterans Affairs Medical Center - Albany *Recruiting*
Albany,  New York,  12208
United States
Recruiting James  Holland 518-462-3311 ext. 2328

Veterans Affairs Medical Center - Portland *Recruiting*
Portland,  Oregon,  97207
United States
Recruiting Craig  Nichols 503-220-8262

Western New York Urology Associates *Recruiting*
Buffalo,  New York,  14220
United States
Recruiting Scott  Perrapato 716-828-3369

CCOP - Dayton *Recruiting*
Dayton,  Ohio,  45429
United States
Recruiting Howard  Gross 937-395-8678

CCOP - Central Illinois *Recruiting*
Decatur,  Illinois,  62526
United States
Recruiting James  Wade 217-876-6617

University of Texas - MD Anderson Cancer Center *Recruiting*
Houston,  Texas,  77030-4095
United States
Recruiting Scott  Lippman 713-745-3672

MBCCOP - Hawaii *Recruiting*
Honolulu,  Hawaii,  96813
United States
Recruiting Brian  Issell 808-586-3013

University of Michigan Comprehensive Cancer Center *Recruiting*
Ann Arbor,  Michigan,  48109-0330
United States
Recruiting Cheryl  Lee 734-615-6662

Veterans Affairs Medical Center - Chicago (Westside Hospital) *Recruiting*
Chicago,  Illinois,  60612
United States
Recruiting Thomas  Lad 312-996-2046

CCOP - St. Louis-Cape Girardeau *Recruiting*
St. Louis,  Missouri,  63141
United States
Recruiting Patrick  Henry 314-569-6573

Hollings Cancer Center at Medical University of South Carolina *Recruiting*
Charleston,  South Carolina,  29425
United States
Recruiting Carolyn  Reed 843-792-3362

CCOP - Grand Rapids *Recruiting*
Grand Rapids,  Michigan,  49503
United States
Recruiting Kathleen  Yost 616-391-1230

Puget Sound Oncology Consortium *Recruiting*
Seattle,  Washington,  98109
United States
Recruiting Saul  Rivkin 206-386-2441

Veterans Affairs Medical Center - Amarillo *Recruiting*
Amarillo,  Texas,  79106
United States
Recruiting William  Robinson 806-355-9703

St. Louis University Hospital Cancer Center *Recruiting*
St. Louis,  Missouri,  63110
United States
Recruiting Paul  Petruska 314-577-8854

Veterans Affairs Medical Center - Tucson *Recruiting*
Tucson,  Arizona,  85723
United States
Recruiting Thomas  Miller 520-792-1450 ext. 16631

CCOP - Scott and White Hospital *Recruiting*
Temple,  Texas,  76508
United States
Recruiting Lucas  Wong 254-724-7048

MBCCOP - LSU Health Sciences Center *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Jill  Gilbert 504-568-5136

Huntsman Cancer Institute *Recruiting*
Salt Lake City,  Utah,  84112-5550
United States
Recruiting Wolfram  Samlowski 801-585-0255

USC/Norris Comprehensive Cancer Center and Hospital *Recruiting*
Los Angeles,  California,  90033
United States
Recruiting Heinz-Josef  Lenz 323-865-3955

CCOP - Michigan Cancer Research Consortium *Recruiting*
Ann Arbor,  Michigan,  48106
United States
Recruiting Philip  Stella 734-712-2000

Veterans Affairs Medical Center - Charleston *Recruiting*
Charleston,  South Carolina,  29401-5799
United States
Recruiting Andrew  Turrisi 843-792-273

Veterans Affairs Medical Center - New Orleans *Recruiting*
New Orleans,  Louisiana,  70112
United States
Recruiting Alan  Miller 504-589-5250

David Grant Medical Center *Recruiting*
Travis Air Force Base,  California,  94535
United States
Recruiting David  Gandara 707-423-7300

University of Mississippi Medical Center *Recruiting*
Jackson,  Mississippi,  39216-4505
United States
Recruiting James  Thigpen 601-984-5590

Veterans Affairs Medical Center - Jackson *Recruiting*
Jackson,  Mississippi,  39216
United States
Recruiting James  Thigpen 601-362-4471

CCOP - Western Regional, Arizona *Recruiting*
Phoenix,  Arizona,  85006-2726
United States
Recruiting David  King 602-258-4875


Additional Information:
Study ID Numbers:
  CDR0000256921;  SWOG-S0219
Study Start Date: 
Record last reviewed: September 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00045630

Other Transitional Cell Cancer Of The Renal Pelvis And Ureter Studies:
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2. LMB-9 Immunotoxin in Treating Patients With Advanced Colon, Breast, Non-small Cell Lung, Bladder, Pancreatic, or Ovarian Cancer

3. Decitabine in Treating Patients With Advanced Solid Tumors

4. Gefitinib Plus Combination Chemotherapy in Treating Patients With Locally Advanced or Metastatic Bladder Cancer

5. Combination Chemotherapy in Patients With Advanced Urinary Tract Cancer

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