Bladder Cancer Clinical Trial

Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Summary

This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells.

View Full Description

Full Description

PRIMARY OBJECTIVES:

I. To determine the acute toxicity (=< 90 days from protocol treatment start) from chemoradiotherapy including paclitaxel +/- trastuzumab and irradiation in non-cystectomy patients with or without her2/neu overexpression.

SECONDARY OBJECTIVES:

I. To determine the ability of patients with bladder cancer who are non-cystectomy candidates to complete this treatment program.

II. To evaluate the efficacy of this treatment program in achieving a complete response of the primary tumor.

III. To measure the 5-year disease-free and overall survival of patients with bladder cancer treated with transurethral resection of the bladder followed by chemoradiotherapy.

IV. To estimate the value of tumor and/or serum biomarkers as predictors of initial tumor response and recurrence-free survival.

OUTLINE: This is a non-randomized, multicenter study. Patients are assigned to 1 of 2 treatment groups according to HER2/neu status (HER2/neu 2+ or 3+ staining [group 1] vs HER2/neu 0 or 1+ staining [group 2]).

GROUP I: Patients receive paclitaxel intravenously (IV) over 1 hour on days 1, 8, 15, 22, 29, 36, and 43 and trastuzumab (Herceptin®) 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.

GROUP II: Patients receive paclitaxel and undergo radiotherapy as in group 1.

After completion of study treatment, patients are followed at 4-5 weeks, every 3 months for 1 year, every 4 months for 1 year, every 6 months for 3 years, and then annually thereafter.

View Eligibility Criteria

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

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT00238420

Recruitment Status:

Completed

Sponsor:

National Cancer Institute (NCI)

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There are 146 Locations for this study

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Mobile Infirmary Medical Center
Mobile Alabama, 36607, United States
Providence Alaska Medical Center
Anchorage Alaska, 99508, United States
Sutter Cancer Centers Radiation Oncology Services-Auburn
Auburn California, 95603, United States
Providence Saint Joseph Medical Center/Disney Family Cancer Center
Burbank California, 91505, United States
Sutter Cancer Centers Radiation Oncology Services-Cameron Park
Cameron Park California, 95682, United States
Mercy San Juan Medical Center
Carmichael California, 95608, United States
Sutter Cancer Centers Radiation Oncology Services-Roseville
Roseville California, 95661, United States
Sutter Medical Center Sacramento
Sacramento California, 95816, United States
Mercy General Hospital Radiation Oncology Center
Sacramento California, 95819, United States
Sutter Cancer Centers Radiation Oncology Services-Vacaville
Vacaville California, 95687, United States
Penrose-Saint Francis Healthcare
Colorado Springs Colorado, 80907, United States
The Reverend Roger Patrick Dorcy Cancer Center at Saint Mary-Corwin Medical Center
Pueblo Colorado, 81004, United States
Beebe Medical Center
Lewes Delaware, 19958, United States
Christiana Care Health System-Christiana Hospital
Newark Delaware, 19718, United States
Saint Francis Hospital - Wilmington
Wilmington Delaware, 19805, United States
MedStar Georgetown University Hospital
Washington District of Columbia, 20007, United States
Holy Cross Hospital
Fort Lauderdale Florida, 33308, United States
University of Florida Health Science Center - Jacksonville
Jacksonville Florida, 32209, United States
Jupiter Medical Center
Jupiter Florida, 33458, United States
Mount Sinai Medical Center
Miami Beach Florida, 33140, United States
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami Florida, 33136, United States
Orlando Health Cancer Institute
Orlando Florida, 32806, United States
Bay Medical Center
Panama City Florida, 32401, United States
Rush - Copley Medical Center
Aurora Illinois, 60504, United States
Saint Joseph Medical Center
Bloomington Illinois, 61701, United States
Illinois CancerCare-Bloomington
Bloomington Illinois, 61704, United States
Graham Hospital Association
Canton Illinois, 61520, United States
Illinois CancerCare-Canton
Canton Illinois, 61520, United States
Illinois CancerCare-Carthage
Carthage Illinois, 62321, United States
Memorial Hospital
Carthage Illinois, 62321, United States
Decatur Memorial Hospital
Decatur Illinois, 62526, United States
Heartland Cancer Research NCORP
Decatur Illinois, 62526, United States
Eureka Hospital
Eureka Illinois, 61530, United States
Illinois CancerCare-Eureka
Eureka Illinois, 61530, United States
Galesburg Cottage Hospital
Galesburg Illinois, 61401, United States
Illinois CancerCare-Galesburg
Galesburg Illinois, 61401, United States
Western Illinois Cancer Treatment Center
Galesburg Illinois, 61401, United States
Illinois CancerCare-Havana
Havana Illinois, 62644, United States
Mason District Hospital
Havana Illinois, 62644, United States
Hopedale Medical Complex - Hospital
Hopedale Illinois, 61747, United States
Duly Health and Care Joliet
Joliet Illinois, 60435, United States
Illinois CancerCare-Kewanee Clinic
Kewanee Illinois, 61443, United States
Kewanee Hospital
Kewanee Illinois, 61443, United States
Illinois CancerCare-Macomb
Macomb Illinois, 61455, United States
Mcdonough District Hospital
Macomb Illinois, 61455, United States
Holy Family Medical Center
Monmouth Illinois, 61462, United States
Illinois CancerCare-Monmouth
Monmouth Illinois, 61462, United States
Bromenn Regional Medical Center
Normal Illinois, 61761, United States
Carle Cancer Institute Normal
Normal Illinois, 61761, United States
Illinois CancerCare-Community Cancer Center
Normal Illinois, 61761, United States
Illinois CancerCare-Ottawa Clinic
Ottawa Illinois, 61350, United States
Ottawa Regional Hospital and Healthcare Center
Ottawa Illinois, 61350, United States
Illinois CancerCare-Pekin
Pekin Illinois, 61554, United States
OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center
Pekin Illinois, 61554, United States
Pekin Hospital
Pekin Illinois, 61554, United States
Proctor Hospital
Peoria Illinois, 61614, United States
Illinois CancerCare-Peoria
Peoria Illinois, 61615, United States
OSF Saint Francis Radiation Oncology at Peoria Cancer Center
Peoria Illinois, 61615, United States
Methodist Medical Center of Illinois
Peoria Illinois, 61636, United States
OSF Saint Francis Medical Center
Peoria Illinois, 61637, United States
Illinois CancerCare-Peru
Peru Illinois, 61354, United States
Illinois Valley Hospital
Peru Illinois, 61354, United States
Valley Radiation Oncology
Peru Illinois, 61354, United States
Illinois CancerCare-Princeton
Princeton Illinois, 61356, United States
Perry Memorial Hospital
Princeton Illinois, 61356, United States
Illinois CancerCare-Spring Valley
Spring Valley Illinois, 61362, United States
Saint Margaret's Hospital
Spring Valley Illinois, 61362, United States
Memorial Medical Center
Springfield Illinois, 62781, United States
Carle Cancer Center
Urbana Illinois, 61801, United States
Radiation Oncology Associates PC
Fort Wayne Indiana, 46804, United States
Parkview Hospital Randallia
Fort Wayne Indiana, 46805, United States
Franciscan Saint Anthony Health-Michigan City
Michigan City Indiana, 46360, United States
McFarland Clinic PC - Ames
Ames Iowa, 50010, United States
Mercy Capitol
Des Moines Iowa, 50307, United States
Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Iowa-Wide Oncology Research Coalition NCORP
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Des Moines
Des Moines Iowa, 50309, United States
Medical Oncology and Hematology Associates-Laurel
Des Moines Iowa, 50314, United States
Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Siouxland Regional Cancer Center
Sioux City Iowa, 51101, United States
Mercy Medical Center-Sioux City
Sioux City Iowa, 51102, United States
Saint Luke's Regional Medical Center
Sioux City Iowa, 51104, United States
Cancer Center of Kansas - Dodge City
Dodge City Kansas, 67801, United States
Cancer Center of Kansas - El Dorado
El Dorado Kansas, 67042, United States
University of Kansas Cancer Center
Kansas City Kansas, 66160, United States
Lawrence Memorial Hospital
Lawrence Kansas, 66044, United States
Southwest Medical Center
Liberal Kansas, 67901, United States
Cancer Center of Kansas - Salina
Salina Kansas, 67401, United States
Cancer Center of Kansas - Wellington
Wellington Kansas, 67152, United States
Associates In Womens Health
Wichita Kansas, 67208, United States
Cancer Center of Kansas-Wichita Medical Arts Tower
Wichita Kansas, 67208, United States
Ascension Via Christi Hospitals Wichita
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Wichita
Wichita Kansas, 67214, United States
Wesley Medical Center
Wichita Kansas, 67214, United States
Wichita NCI Community Oncology Research Program
Wichita Kansas, 67214, United States
Cancer Center of Kansas - Winfield
Winfield Kansas, 67156, United States
University of Kentucky/Markey Cancer Center
Lexington Kentucky, 40536, United States
Christiana Care - Union Hospital
Elkton Maryland, 21921, United States
Massachusetts General Hospital Cancer Center
Boston Massachusetts, 02114, United States
Boston Medical Center
Boston Massachusetts, 02118, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
Saint Anne's Hospital
Fall River Massachusetts, 02721, United States
University of Michigan Comprehensive Cancer Center
Ann Arbor Michigan, 48109, United States
Bronson Methodist Hospital
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
Borgess Medical Center
Kalamazoo Michigan, 49048, United States
Singing River Hospital
Pascagoula Mississippi, 39581, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
Mercy Hospital Springfield
Springfield Missouri, 65804, United States
Billings Clinic Cancer Center
Billings Montana, 59101, United States
Northern Rockies Radiation Oncology Center
Billings Montana, 59101, United States
Montana Cancer Consortium NCORP
Billings Montana, 59102, United States
Bozeman Deaconess Hospital
Bozeman Montana, 59715, United States
Benefis Healthcare- Sletten Cancer Institute
Great Falls Montana, 59405, United States
Berdeaux, Donald MD (UIA Investigator)
Great Falls Montana, 59405, United States
Great Falls Clinic
Great Falls Montana, 59405, United States
University Medical Center of Southern Nevada
Las Vegas Nevada, 89102, United States
Nevada Cancer Institute-Summerlin Campus
Las Vegas Nevada, 89135, United States
Nevada Cancer Research Foundation NCORP
Las Vegas Nevada, 89169, United States
Cheshire Medical Center-Dartmouth-Hitchcock Keene
Keene New Hampshire, 03431, United States
Dartmouth Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Cooper Hospital University Medical Center
Camden New Jersey, 08103, United States
Virtua Memorial
Mount Holly New Jersey, 08060, United States
Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States
Rutgers Cancer Institute of New Jersey
New Brunswick New Jersey, 08903, United States
Inspira Medical Center Vineland
Vineland New Jersey, 08360, United States
Hudson Valley Oncology Associates
Poughkeepsie New York, 12601, United States
Novant Health Presbyterian Medical Center
Charlotte North Carolina, 28204, United States
Vidant Oncology-Kinston
Kinston North Carolina, 28501, United States
Mid Dakota Clinic
Bismarck North Dakota, 58501, United States
Saint Alexius Medical Center
Bismarck North Dakota, 58501, United States
Sanford Bismarck Medical Center
Bismarck North Dakota, 58501, United States
Summa Health System - Akron Campus
Akron Ohio, 44304, United States
Cleveland Clinic Akron General
Akron Ohio, 44307, United States
Summa Health System - Barberton Campus
Barberton Ohio, 44203, United States
Cleveland Clinic Mercy Hospital
Canton Ohio, 44708, United States
MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Cleveland Clinic Foundation
Cleveland Ohio, 44195, United States
UH Seidman Cancer Center at Salem Regional Medical Center
Salem Ohio, 44460, United States
Springfield Regional Medical Center
Springfield Ohio, 45505, United States
Cancer Treatment Center
Wooster Ohio, 44691, United States
University of Oklahoma Health Sciences Center
Oklahoma City Oklahoma, 73104, United States
Clackamas Radiation Oncology Center
Clackamas Oregon, 97015, United States
Providence Milwaukie Hospital
Milwaukie Oregon, 97222, United States
Providence Portland Medical Center
Portland Oregon, 97213, United States
Providence Saint Vincent Medical Center
Portland Oregon, 97225, United States
Delaware County Memorial Hospital
Drexel Hill Pennsylvania, 19026, United States
Northeast Radiation Oncology Center
Dunmore Pennsylvania, 18512, United States
Fox Chase Cancer Center Buckingham
Furlong Pennsylvania, 18925, United States
Riddle Memorial Hospital
Media Pennsylvania, 19063, United States
Thomas Jefferson University Hospital
Philadelphia Pennsylvania, 19107, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Lankenau Medical Center
Wynnewood Pennsylvania, 19096, United States
Main Line Health NCORP
Wynnewood Pennsylvania, 19096, United States
Medical University of South Carolina
Charleston South Carolina, 29425, United States
UT Southwestern/Simmons Cancer Center-Dallas
Dallas Texas, 75390, United States
Sandra L Maxwell Cancer Center
Cedar City Utah, 84720, United States
Logan Regional Hospital
Logan Utah, 84321, United States
Cottonwood Hospital Medical Center
Murray Utah, 84107, United States
Intermountain Medical Center
Murray Utah, 84107, United States
McKay-Dee Hospital Center
Ogden Utah, 84403, United States
Utah Valley Regional Medical Center
Provo Utah, 84604, United States
Saint George Regional Medical Center
Saint George Utah, 84770, United States
Utah Cancer Specialists-Salt Lake City
Salt Lake City Utah, 84106, United States
LDS Hospital
Salt Lake City Utah, 84143, United States
Norris Cotton Cancer Center-North
Saint Johnsbury Vermont, 05819, United States
Danville Regional Medical Center
Danville Virginia, 24541, United States
Saint Francis Hospital
Federal Way Washington, 98003, United States
EvergreenHealth Medical Center
Kirkland Washington, 98033, United States
MultiCare Good Samaritan Hospital
Puyallup Washington, 98372, United States
Valley Medical Center
Renton Washington, 98055, United States
Virginia Mason Medical Center
Seattle Washington, 98101, United States
MultiCare Tacoma General Hospital
Tacoma Washington, 98405, United States
Northwest NCI Community Oncology Research Program
Tacoma Washington, 98405, United States
Saint Joseph Medical Center
Tacoma Washington, 98405, United States
PeaceHealth Southwest Medical Center
Vancouver Washington, 98664, United States
Compass Oncology Vancouver
Vancouver Washington, 98684, United States
Medical College of Wisconsin
Milwaukee Wisconsin, 53226, United States
Welch Cancer Center
Sheridan Wyoming, 82801, United States
Cross Cancer Institute
Edmonton Alberta, T6G 1, Canada
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John New Brunswick, E2L 4, Canada
London Regional Cancer Program
London Ontario, N6A 4, Canada
McGill University Department of Oncology
Montreal Quebec, H2W 1, Canada

How clear is this clinincal trial information?

Study is for people with:

Bladder Cancer

Phase:

Phase 1

Estimated Enrollment:

70

Study ID:

NCT00238420

Recruitment Status:

Completed

Sponsor:


National Cancer Institute (NCI)

How clear is this clinincal trial information?

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