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NCT00238420 Clinical Trial

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

Bladder Urothelial Carcinoma Clinical Trial

Official title:
A Phase I/II Trial of a Combination of Paclitaxel and Trastuzumab With Daily Irradiation or Paclitaxel Alone With Daily Irradiation Following Transurethral Surgery for Non-Cystectomy Candidates With Muscle-Invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00238420
Other study ID # NCI-2009-00730
Secondary ID NCI-2009-00730RT
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 26, 2005
Est. completion date May 20, 2022

Study information
Verified date May 2022
Source National Cancer Institute (NCI)
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 70
Est. completion date May 20, 2022
Est. primary completion date February 5, 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Paclitaxel
Given IV
Radiation:
• Radiation Therapy
Undergo radiation therapy
Biological:
• Trastuzumab
Given IV

Locations
Country Name City State
Canada Cross Cancer Institute Edmonton Alberta
Canada London Regional Cancer Program London Ontario
Canada McGill University Department of Oncology Montreal Quebec
Canada Atlantic Health Sciences Corporation-Saint John Regional Hospital Saint John New Brunswick
United States Cleveland Clinic Akron General Akron Ohio
United States Summa Health System - Akron Campus Akron Ohio
United States McFarland Clinic PC - Ames Ames Iowa
United States Providence Alaska Medical Center Anchorage Alaska
United States University of Michigan Comprehensive Cancer Center Ann Arbor Michigan
United States Sutter Cancer Centers Radiation Oncology Services-Auburn Auburn California
United States Rush - Copley Medical Center Aurora Illinois
United States Summa Health System - Barberton Campus Barberton Ohio
United States Billings Clinic Cancer Center Billings Montana
United States Montana Cancer Consortium NCORP Billings Montana
United States Northern Rockies Radiation Oncology Center Billings Montana
United States Mid Dakota Clinic Bismarck North Dakota
United States Saint Alexius Medical Center Bismarck North Dakota
United States Sanford Bismarck Medical Center Bismarck North Dakota
United States Illinois CancerCare-Bloomington Bloomington Illinois
United States Saint Joseph Medical Center Bloomington Illinois
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Boston Medical Center Boston Massachusetts
United States Massachusetts General Hospital Cancer Center Boston Massachusetts
United States Bozeman Deaconess Hospital Bozeman Montana
United States Providence Saint Joseph Medical Center/Disney Family Cancer Center Burbank California
United States Cooper Hospital University Medical Center Camden New Jersey
United States Sutter Cancer Centers Radiation Oncology Services-Cameron Park Cameron Park California
United States Cleveland Clinic Mercy Hospital Canton Ohio
United States Graham Hospital Association Canton Illinois
United States Illinois CancerCare-Canton Canton Illinois
United States Mercy San Juan Medical Center Carmichael California
United States Illinois CancerCare-Carthage Carthage Illinois
United States Memorial Hospital Carthage Illinois
United States Sandra L Maxwell Cancer Center Cedar City Utah
United States Medical University of South Carolina Charleston South Carolina
United States Novant Health Presbyterian Medical Center Charlotte North Carolina
United States Clackamas Radiation Oncology Center Clackamas Oregon
United States Cleveland Clinic Foundation Cleveland Ohio
United States MetroHealth Medical Center Cleveland Ohio
United States Penrose-Saint Francis Healthcare Colorado Springs Colorado
United States UT Southwestern/Simmons Cancer Center-Dallas Dallas Texas
United States Danville Regional Medical Center Danville Virginia
United States Decatur Memorial Hospital Decatur Illinois
United States Heartland Cancer Research NCORP Decatur Illinois
United States Iowa Lutheran Hospital Des Moines Iowa
United States Iowa Methodist Medical Center Des Moines Iowa
United States Iowa-Wide Oncology Research Coalition NCORP Des Moines Iowa
United States Medical Oncology and Hematology Associates-Des Moines Des Moines Iowa
United States Medical Oncology and Hematology Associates-Laurel Des Moines Iowa
United States Mercy Capitol Des Moines Iowa
United States Mercy Medical Center - Des Moines Des Moines Iowa
United States Cancer Center of Kansas - Dodge City Dodge City Kansas
United States Delaware County Memorial Hospital Drexel Hill Pennsylvania
United States Northeast Radiation Oncology Center Dunmore Pennsylvania
United States Cancer Center of Kansas - El Dorado El Dorado Kansas
United States Christiana Care - Union Hospital Elkton Maryland
United States Eureka Hospital Eureka Illinois
United States Illinois CancerCare-Eureka Eureka Illinois
United States Saint Anne's Hospital Fall River Massachusetts
United States Saint Francis Hospital Federal Way Washington
United States Holy Cross Hospital Fort Lauderdale Florida
United States Parkview Hospital Randallia Fort Wayne Indiana
United States Radiation Oncology Associates PC Fort Wayne Indiana
United States Fox Chase Cancer Center Buckingham Furlong Pennsylvania
United States Galesburg Cottage Hospital Galesburg Illinois
United States Illinois CancerCare-Galesburg Galesburg Illinois
United States Western Illinois Cancer Treatment Center Galesburg Illinois
United States Benefis Healthcare- Sletten Cancer Institute Great Falls Montana
United States Berdeaux, Donald MD (UIA Investigator) Great Falls Montana
United States Great Falls Clinic Great Falls Montana
United States Illinois CancerCare-Havana Havana Illinois
United States Mason District Hospital Havana Illinois
United States Hopedale Medical Complex - Hospital Hopedale Illinois
United States University of Florida Health Science Center - Jacksonville Jacksonville Florida
United States Duly Health and Care Joliet Joliet Illinois
United States Jupiter Medical Center Jupiter Florida
United States Borgess Medical Center Kalamazoo Michigan
United States Bronson Methodist Hospital Kalamazoo Michigan
United States West Michigan Cancer Center Kalamazoo Michigan
United States University of Kansas Cancer Center Kansas City Kansas
United States Cheshire Medical Center-Dartmouth-Hitchcock Keene Keene New Hampshire
United States Illinois CancerCare-Kewanee Clinic Kewanee Illinois
United States Kewanee Hospital Kewanee Illinois
United States Vidant Oncology-Kinston Kinston North Carolina
United States EvergreenHealth Medical Center Kirkland Washington
United States Nevada Cancer Institute-Summerlin Campus Las Vegas Nevada
United States Nevada Cancer Research Foundation NCORP Las Vegas Nevada
United States University Medical Center of Southern Nevada Las Vegas Nevada
United States Lawrence Memorial Hospital Lawrence Kansas
United States Dartmouth Hitchcock Medical Center Lebanon New Hampshire
United States Beebe Medical Center Lewes Delaware
United States University of Kentucky/Markey Cancer Center Lexington Kentucky
United States Southwest Medical Center Liberal Kansas
United States Logan Regional Hospital Logan Utah
United States Illinois CancerCare-Macomb Macomb Illinois
United States Mcdonough District Hospital Macomb Illinois
United States Riddle Memorial Hospital Media Pennsylvania
United States University of Miami Miller School of Medicine-Sylvester Cancer Center Miami Florida
United States Mount Sinai Medical Center Miami Beach Florida
United States Franciscan Saint Anthony Health-Michigan City Michigan City Indiana
United States Medical College of Wisconsin Milwaukee Wisconsin
United States Providence Milwaukie Hospital Milwaukie Oregon
United States Mobile Infirmary Medical Center Mobile Alabama
United States Holy Family Medical Center Monmouth Illinois
United States Illinois CancerCare-Monmouth Monmouth Illinois
United States Virtua Memorial Mount Holly New Jersey
United States Cottonwood Hospital Medical Center Murray Utah
United States Intermountain Medical Center Murray Utah
United States Rutgers Cancer Institute of New Jersey New Brunswick New Jersey
United States Rutgers Cancer Institute of New Jersey-Robert Wood Johnson University Hospital New Brunswick New Jersey
United States Christiana Care Health System-Christiana Hospital Newark Delaware
United States Bromenn Regional Medical Center Normal Illinois
United States Carle Cancer Institute Normal Normal Illinois
United States Illinois CancerCare-Community Cancer Center Normal Illinois
United States McKay-Dee Hospital Center Ogden Utah
United States University of Oklahoma Health Sciences Center Oklahoma City Oklahoma
United States Orlando Health Cancer Institute Orlando Florida
United States Illinois CancerCare-Ottawa Clinic Ottawa Illinois
United States Ottawa Regional Hospital and Healthcare Center Ottawa Illinois
United States Bay Medical Center Panama City Florida
United States Singing River Hospital Pascagoula Mississippi
United States Illinois CancerCare-Pekin Pekin Illinois
United States OSF Saint Francis Radiation Oncology at Pekin Cancer Treatment Center Pekin Illinois
United States Pekin Hospital Pekin Illinois
United States Illinois CancerCare-Peoria Peoria Illinois
United States Methodist Medical Center of Illinois Peoria Illinois
United States OSF Saint Francis Medical Center Peoria Illinois
United States OSF Saint Francis Radiation Oncology at Peoria Cancer Center Peoria Illinois
United States Proctor Hospital Peoria Illinois
United States Illinois CancerCare-Peru Peru Illinois
United States Illinois Valley Hospital Peru Illinois
United States Valley Radiation Oncology Peru Illinois
United States Fox Chase Cancer Center Philadelphia Pennsylvania
United States Thomas Jefferson University Hospital Philadelphia Pennsylvania
United States Providence Portland Medical Center Portland Oregon
United States Providence Saint Vincent Medical Center Portland Oregon
United States Hudson Valley Oncology Associates Poughkeepsie New York
United States Illinois CancerCare-Princeton Princeton Illinois
United States Perry Memorial Hospital Princeton Illinois
United States Utah Valley Regional Medical Center Provo Utah
United States The Reverend Roger Patrick Dorcy Cancer Center at Saint Mary-Corwin Medical Center Pueblo Colorado
United States MultiCare Good Samaritan Hospital Puyallup Washington
United States Valley Medical Center Renton Washington
United States Sutter Cancer Centers Radiation Oncology Services-Roseville Roseville California
United States Mercy General Hospital Radiation Oncology Center Sacramento California
United States Sutter Medical Center Sacramento Sacramento California
United States Saint George Regional Medical Center Saint George Utah
United States Norris Cotton Cancer Center-North Saint Johnsbury Vermont
United States Washington University School of Medicine Saint Louis Missouri
United States UH Seidman Cancer Center at Salem Regional Medical Center Salem Ohio
United States Cancer Center of Kansas - Salina Salina Kansas
United States LDS Hospital Salt Lake City Utah
United States Utah Cancer Specialists-Salt Lake City Salt Lake City Utah
United States Virginia Mason Medical Center Seattle Washington
United States Welch Cancer Center Sheridan Wyoming
United States Mercy Medical Center-Sioux City Sioux City Iowa
United States Saint Luke's Regional Medical Center Sioux City Iowa
United States Siouxland Regional Cancer Center Sioux City Iowa
United States Illinois CancerCare-Spring Valley Spring Valley Illinois
United States Saint Margaret's Hospital Spring Valley Illinois
United States Memorial Medical Center Springfield Illinois
United States Mercy Hospital Springfield Springfield Missouri
United States Springfield Regional Medical Center Springfield Ohio
United States MultiCare Tacoma General Hospital Tacoma Washington
United States Northwest NCI Community Oncology Research Program Tacoma Washington
United States Saint Joseph Medical Center Tacoma Washington
United States Carle Cancer Center Urbana Illinois
United States Sutter Cancer Centers Radiation Oncology Services-Vacaville Vacaville California
United States Compass Oncology Vancouver Vancouver Washington
United States PeaceHealth Southwest Medical Center Vancouver Washington
United States Inspira Medical Center Vineland Vineland New Jersey
United States MedStar Georgetown University Hospital Washington District of Columbia
United States Cancer Center of Kansas - Wellington Wellington Kansas
United States Ascension Via Christi Hospitals Wichita Wichita Kansas
United States Associates In Womens Health Wichita Kansas
United States Cancer Center of Kansas - Wichita Wichita Kansas
United States Cancer Center of Kansas-Wichita Medical Arts Tower Wichita Kansas
United States Wesley Medical Center Wichita Kansas
United States Wichita NCI Community Oncology Research Program Wichita Kansas
United States Saint Francis Hospital - Wilmington Wilmington Delaware
United States Cancer Center of Kansas - Winfield Winfield Kansas
United States Cancer Treatment Center Wooster Ohio
United States Lankenau Medical Center Wynnewood Pennsylvania
United States Main Line Health NCORP Wynnewood Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
National Cancer Institute (NCI) Radiation Therapy Oncology Group

Countries where clinical trial is conducted

United States,  Canada, 

Outcome
Type Measure Description Time frame Safety issue
Primary Acute Treatment-related Toxicity In each group, the number of patients was tabulated by type and grade (gr) of treatment-related toxicity (CTCAE v3.0). Only the following types of toxicity within 90 days of treatment start were considered: = gr4 neutropenia, = gr4 febrile neutropenia, = gr3 diarrhea, = gr3 nausea/vomiting, = gr3 thrombocytopenia, = gr3 renal, pulmonary, hepatic, or neurologic toxicity, = gr3 rectal or genitourinary bleeding, = gr3 left ventricular failure, or = gr2 other cardiac toxicity. The study was designed to estimate the rate of acute treatment-related toxicity separately in each group of patients. Using the Fleming's one-sample multiple test procedure with Type I and II errors each set at 10%, 40 cases/group were required to reject the null hypothesis that the true toxicity rate is greater than 25% in favor of the alternative hypothesis that the true rate is no more than 10%. Six or more patients with the designated toxicities out of 40 would result in rejecting the null hypothesis. From start of protocol treatment to 90 days
Secondary Treatment Completion The number of patients within each group who completed all elements of protocol treatment are reported. From registration to end of treatment; up to 64 days."
Secondary Complete Response to Treatment The number of patients within each group who achieved a complete response to protocol treatment by 12 weeks are reported. Complete response is defined as no gross tumor at cystoscopy or negative biopsies or both by week 12 after completion of protocol treatment. At 12 weeks from treatment start
Secondary Progression-free Survival Disease (failure) is defined as any bladder cancer progression determined by all measures of disease including physical exam, imaging, and biopsies. Disease-free survival time is defined as time from treatment start to the date of first progression, death, or last known follow-up (censored). Disease-free survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared. From start of treatment to last follow-up. Maximum follow-up at time of analysis was 9.9 years.
Secondary Overall Survival Overall survival time is defined as time from treatment start to the date of death from any cause or last known follow-up (censored). Overall survival rates are estimated using the Kaplan-Meier method. Analysis occurred after all patients had been on study for at least 5 years. This is a non-randomized phase I/II trial in which the two patient groups are not compared. From the date of treatment started to death, assessed up to at least 5 years
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