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.
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.
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
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There are 146 Locations for this study
Mobile Alabama, 36607, United States
Anchorage Alaska, 99508, United States
Auburn California, 95603, United States
Burbank California, 91505, United States
Cameron Park California, 95682, United States
Carmichael California, 95608, United States
Roseville California, 95661, United States
Sacramento California, 95816, United States
Sacramento California, 95819, United States
Vacaville California, 95687, United States
Colorado Springs Colorado, 80907, United States
Pueblo Colorado, 81004, United States
Lewes Delaware, 19958, United States
Newark Delaware, 19718, United States
Wilmington Delaware, 19805, United States
Washington District of Columbia, 20007, United States
Fort Lauderdale Florida, 33308, United States
Jacksonville Florida, 32209, United States
Jupiter Florida, 33458, United States
Miami Beach Florida, 33140, United States
Miami Florida, 33136, United States
Orlando Florida, 32806, United States
Panama City Florida, 32401, United States
Aurora Illinois, 60504, United States
Bloomington Illinois, 61701, United States
Bloomington Illinois, 61704, United States
Canton Illinois, 61520, United States
Canton Illinois, 61520, United States
Carthage Illinois, 62321, United States
Carthage Illinois, 62321, United States
Decatur Illinois, 62526, United States
Decatur Illinois, 62526, United States
Eureka Illinois, 61530, United States
Eureka Illinois, 61530, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Galesburg Illinois, 61401, United States
Havana Illinois, 62644, United States
Havana Illinois, 62644, United States
Hopedale Illinois, 61747, United States
Joliet Illinois, 60435, United States
Kewanee Illinois, 61443, United States
Kewanee Illinois, 61443, United States
Macomb Illinois, 61455, United States
Macomb Illinois, 61455, United States
Monmouth Illinois, 61462, United States
Monmouth Illinois, 61462, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Normal Illinois, 61761, United States
Ottawa Illinois, 61350, United States
Ottawa Illinois, 61350, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Pekin Illinois, 61554, United States
Peoria Illinois, 61614, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61615, United States
Peoria Illinois, 61636, United States
Peoria Illinois, 61637, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Peru Illinois, 61354, United States
Princeton Illinois, 61356, United States
Princeton Illinois, 61356, United States
Spring Valley Illinois, 61362, United States
Spring Valley Illinois, 61362, United States
Springfield Illinois, 62781, United States
Urbana Illinois, 61801, United States
Fort Wayne Indiana, 46804, United States
Fort Wayne Indiana, 46805, United States
Michigan City Indiana, 46360, United States
Ames Iowa, 50010, United States
Des Moines Iowa, 50307, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50309, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50314, United States
Des Moines Iowa, 50316, United States
Sioux City Iowa, 51101, United States
Sioux City Iowa, 51102, United States
Sioux City Iowa, 51104, United States
Dodge City Kansas, 67801, United States
El Dorado Kansas, 67042, United States
Kansas City Kansas, 66160, United States
Lawrence Kansas, 66044, United States
Liberal Kansas, 67901, United States
Salina Kansas, 67401, United States
Wellington Kansas, 67152, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67208, United States
Wichita Kansas, 67214, 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
Elkton Maryland, 21921, United States
Boston Massachusetts, 02114, United States
Boston Massachusetts, 02118, United States
Boston Massachusetts, 02215, United States
Fall River Massachusetts, 02721, United States
Ann Arbor Michigan, 48109, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49007, United States
Kalamazoo Michigan, 49048, United States
Pascagoula Mississippi, 39581, United States
Saint Louis Missouri, 63110, United States
Springfield Missouri, 65804, United States
Billings Montana, 59101, United States
Billings Montana, 59101, United States
Billings Montana, 59102, United States
Bozeman Montana, 59715, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Great Falls Montana, 59405, United States
Las Vegas Nevada, 89102, United States
Las Vegas Nevada, 89135, United States
Las Vegas Nevada, 89169, United States
Keene New Hampshire, 03431, United States
Lebanon New Hampshire, 03756, United States
Camden New Jersey, 08103, United States
Mount Holly New Jersey, 08060, United States
New Brunswick New Jersey, 08903, United States
New Brunswick New Jersey, 08903, United States
Vineland New Jersey, 08360, United States
Poughkeepsie New York, 12601, United States
Charlotte North Carolina, 28204, United States
Kinston North Carolina, 28501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Bismarck North Dakota, 58501, United States
Akron Ohio, 44304, United States
Akron Ohio, 44307, United States
Barberton Ohio, 44203, United States
Canton Ohio, 44708, United States
Cleveland Ohio, 44109, United States
Cleveland Ohio, 44195, United States
Salem Ohio, 44460, United States
Springfield Ohio, 45505, United States
Wooster Ohio, 44691, United States
Oklahoma City Oklahoma, 73104, United States
Clackamas Oregon, 97015, United States
Milwaukie Oregon, 97222, United States
Portland Oregon, 97213, United States
Portland Oregon, 97225, United States
Drexel Hill Pennsylvania, 19026, United States
Dunmore Pennsylvania, 18512, United States
Furlong Pennsylvania, 18925, United States
Media Pennsylvania, 19063, United States
Philadelphia Pennsylvania, 19107, United States
Philadelphia Pennsylvania, 19111, United States
Wynnewood Pennsylvania, 19096, United States
Wynnewood Pennsylvania, 19096, United States
Charleston South Carolina, 29425, United States
Dallas Texas, 75390, United States
Cedar City Utah, 84720, United States
Logan Utah, 84321, United States
Murray Utah, 84107, 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
Saint Johnsbury Vermont, 05819, United States
Danville Virginia, 24541, United States
Federal Way Washington, 98003, United States
Kirkland Washington, 98033, United States
Puyallup Washington, 98372, United States
Renton Washington, 98055, United States
Seattle Washington, 98101, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
Tacoma Washington, 98405, United States
Vancouver Washington, 98664, United States
Vancouver Washington, 98684, United States
Milwaukee Wisconsin, 53226, United States
Sheridan Wyoming, 82801, United States
Edmonton Alberta, T6G 1, Canada
Saint John New Brunswick, E2L 4, Canada
London Ontario, N6A 4, Canada
Montreal Quebec, H2W 1, Canada
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