Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer
Bladder Urothelial Carcinoma, Stage I Bladder Cancer AJCC v6 and v7, Stage II Bladder Cancer AJCC v6 and v7
About this trial
This is an interventional treatment trial for Bladder Urothelial Carcinoma
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder Histologic evidence of muscularis propria invasion Meets 1 of the following stage criteria: Stage T2-4a; NX, N0, or N1; and M0 disease Clinical stage T1, grade 3/3 disease AND requires definitive local therapy Tumor involvement of the prostatic urethra allowed provided the following criteria are met: Tumor was visibly completely resected No evidence of stromal invasion of the prostate No evidence of distant metastases by chest x-ray (or chest CT scan) within 8 weeks prior to registration No evidence of distant metastases by abdominal/pelvic CT scan (or MRI scan) within 8 weeks prior to registration Has undergone transurethral bladder resection (as thorough as is judged safely possible) within the past 3-8 weeks, including bimanual examination with tumor mapping Sufficient tumor tissue available for HER2/neu analysis Not a candidate for radical cystectomy Performance status - Zubrod 0-2 Absolute neutrophil count >= 1,800/mm^3 Platelet count >= 100,000/mm^3 Hemoglobin >= 8.0 g/dL (transfusion or other intervention allowed) Bilirubin < 2.0 mg/dL Serum glutamic oxaloacetic transaminase (SGOT) and serum glutamate pyruvate transaminase (SGPT) < 2.5 times upper limit of normal No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects Creatinine =< 3.0 mg/dL Left ventricular ejection fraction (LVEF) >= 40% by multigated acquisition scan (MUGA) scan or echocardiogram No unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months No transmural myocardial infarction within the past 6 months Not pregnant or nursing No nursing for 6 months after completion of study treatment (for patients receiving trastuzumab [Herceptin®]) Negative pregnancy test Fertile patients must use effective contraception during and for 6 months after completion of study treatment Able to tolerate systemic chemotherapy and pelvic radiotherapy No other invasive malignancy within the past 3 years except nonmelanoma skin cancer No history of allergic reaction to study drugs No history of inflammatory bowel disease No acute bacterial or fungal infection requiring IV antibiotics No AIDS No other severe active comorbidity No prior systemic chemotherapy with anthracyclines or taxanes No prior systemic chemotherapy for TCC No prior pelvic radiotherapy
Sites / Locations
- Mobile Infirmary Medical Center
- Providence Alaska Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Auburn
- Providence Saint Joseph Medical Center/Disney Family Cancer Center
- Sutter Cancer Centers Radiation Oncology Services-Cameron Park
- Mercy San Juan Medical Center
- Sutter Cancer Centers Radiation Oncology Services-Roseville
- Sutter Medical Center Sacramento
- Mercy General Hospital Radiation Oncology Center
- Sutter Cancer Centers Radiation Oncology Services-Vacaville
- Penrose-Saint Francis Healthcare
- The Reverend Roger Patrick Dorcy Cancer Center at Saint Mary-Corwin Medical Center
- Beebe Medical Center
- Christiana Care Health System-Christiana Hospital
- Saint Francis Hospital - Wilmington
- MedStar Georgetown University Hospital
- Holy Cross Hospital
- University of Florida Health Science Center - Jacksonville
- Jupiter Medical Center
- Mount Sinai Medical Center
- University of Miami Miller School of Medicine-Sylvester Cancer Center
- Orlando Health Cancer Institute
- Bay Medical Center
- Rush - Copley Medical Center
- Saint Joseph Medical Center
- Illinois CancerCare-Bloomington
- Graham Hospital Association
- Illinois CancerCare-Canton
- Illinois CancerCare-Carthage
- Memorial Hospital
- Decatur Memorial Hospital
- Heartland Cancer Research NCORP
- Eureka Hospital
- Illinois CancerCare-Eureka
- Galesburg Cottage Hospital
- Illinois CancerCare-Galesburg
- Western Illinois Cancer Treatment Center
- Illinois CancerCare-Havana
- Mason District Hospital
- Hopedale Medical Complex - Hospital
- Duly Health and Care Joliet
- Illinois CancerCare-Kewanee Clinic
- Kewanee Hospital
- Illinois CancerCare-Macomb
- Mcdonough District Hospital
- Holy Family Medical Center
- Illinois CancerCare-Monmouth
- Bromenn Regional Medical Center
- Carle Cancer Institute Normal
- Illinois CancerCare-Community Cancer Center
- Illinois CancerCare-Ottawa Clinic
- Ottawa Regional Hospital and Healthcare Center
- Illinois CancerCare-Pekin
- OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
- Pekin Hospital
- Proctor Hospital
- Illinois CancerCare-Peoria
- OSF Saint Francis Radiation Oncology at Peoria Cancer Center
- Methodist Medical Center of Illinois
- OSF Saint Francis Medical Center
- Illinois CancerCare-Peru
- Illinois Valley Hospital
- Valley Radiation Oncology
- Illinois CancerCare-Princeton
- Perry Memorial Hospital
- Illinois CancerCare-Spring Valley
- Saint Margaret's Hospital
- Memorial Medical Center
- Carle Cancer Center
- Radiation Oncology Associates PC
- Parkview Hospital Randallia
- Franciscan Saint Anthony Health-Michigan City
- McFarland Clinic PC - Ames
- Mercy Capitol
- Iowa Methodist Medical Center
- Iowa-Wide Oncology Research Coalition NCORP
- Medical Oncology and Hematology Associates-Des Moines
- Medical Oncology and Hematology Associates-Laurel
- Mercy Medical Center - Des Moines
- Iowa Lutheran Hospital
- Siouxland Regional Cancer Center
- Mercy Medical Center-Sioux City
- Saint Luke's Regional Medical Center
- Cancer Center of Kansas - Dodge City
- Cancer Center of Kansas - El Dorado
- University of Kansas Cancer Center
- Lawrence Memorial Hospital
- Southwest Medical Center
- Cancer Center of Kansas - Salina
- Cancer Center of Kansas - Wellington
- Associates In Womens Health
- Cancer Center of Kansas-Wichita Medical Arts Tower
- Ascension Via Christi Hospitals Wichita
- Cancer Center of Kansas - Wichita
- Wesley Medical Center
- Wichita NCI Community Oncology Research Program
- Cancer Center of Kansas - Winfield
- University of Kentucky/Markey Cancer Center
- Christiana Care - Union Hospital
- Massachusetts General Hospital Cancer Center
- Boston Medical Center
- Beth Israel Deaconess Medical Center
- Saint Anne's Hospital
- University of Michigan Comprehensive Cancer Center
- Bronson Methodist Hospital
- West Michigan Cancer Center
- Borgess Medical Center
- Singing River Hospital
- Washington University School of Medicine
- Mercy Hospital Springfield
- Billings Clinic Cancer Center
- Northern Rockies Radiation Oncology Center
- Montana Cancer Consortium NCORP
- Bozeman Deaconess Hospital
- Benefis Healthcare- Sletten Cancer Institute
- Berdeaux, Donald MD (UIA Investigator)
- Great Falls Clinic
- University Medical Center of Southern Nevada
- Nevada Cancer Institute-Summerlin Campus
- Nevada Cancer Research Foundation NCORP
- Cheshire Medical Center-Dartmouth-Hitchcock Keene
- Dartmouth Hitchcock Medical Center
- Cooper Hospital University Medical Center
- Virtua Memorial
- Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
- Rutgers Cancer Institute of New Jersey
- Inspira Medical Center Vineland
- Hudson Valley Oncology Associates
- Novant Health Presbyterian Medical Center
- Vidant Oncology-Kinston
- Mid Dakota Clinic
- Saint Alexius Medical Center
- Sanford Bismarck Medical Center
- Summa Health System - Akron Campus
- Cleveland Clinic Akron General
- Summa Health System - Barberton Campus
- Cleveland Clinic Mercy Hospital
- MetroHealth Medical Center
- Cleveland Clinic Foundation
- UH Seidman Cancer Center at Salem Regional Medical Center
- Springfield Regional Medical Center
- Cancer Treatment Center
- University of Oklahoma Health Sciences Center
- Clackamas Radiation Oncology Center
- Providence Milwaukie Hospital
- Providence Portland Medical Center
- Providence Saint Vincent Medical Center
- Delaware County Memorial Hospital
- Northeast Radiation Oncology Center
- Fox Chase Cancer Center Buckingham
- Riddle Memorial Hospital
- Thomas Jefferson University Hospital
- Fox Chase Cancer Center
- Lankenau Medical Center
- Main Line Health NCORP
- Medical University of South Carolina
- UT Southwestern/Simmons Cancer Center-Dallas
- Sandra L Maxwell Cancer Center
- Logan Regional Hospital
- Cottonwood Hospital Medical Center
- Intermountain Medical Center
- McKay-Dee Hospital Center
- Utah Valley Regional Medical Center
- Saint George Regional Medical Center
- Utah Cancer Specialists-Salt Lake City
- LDS Hospital
- Norris Cotton Cancer Center-North
- Danville Regional Medical Center
- Saint Francis Hospital
- EvergreenHealth Medical Center
- MultiCare Good Samaritan Hospital
- Valley Medical Center
- Virginia Mason Medical Center
- MultiCare Tacoma General Hospital
- Northwest NCI Community Oncology Research Program
- Saint Joseph Medical Center
- PeaceHealth Southwest Medical Center
- Compass Oncology Vancouver
- Medical College of Wisconsin
- Welch Cancer Center
- Cross Cancer Institute
- Atlantic Health Sciences Corporation-Saint John Regional Hospital
- London Regional Cancer Program
- McGill University Department of Oncology
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Group I (paclitaxel, trastuzumab, radiation therapy)
Group II (paclitaxel, radiation therapy)
Patients receive paclitaxel IV over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and trastuzumab IV over 90 minutes on day 1 and then over 30 minutes on days 8, 15, 22, 29, 36, and 43. Patients also undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50. Treatment continues in the absence of disease progression or unacceptable toxicity.
Patients receive paclitaxel and undergo radiotherapy once daily on days 1-5, 8-12, 15-19, 22-26, 29-33, 36-40, 43-47, and 50.