Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer
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
6 other identifiers
interventional
70
2 countries
184
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jul 2005
Longer than P75 for phase_1
184 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2005
CompletedFirst Submitted
Initial submission to the registry
October 12, 2005
CompletedFirst Posted
Study publicly available on registry
October 13, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 5, 2014
CompletedResults Posted
Study results publicly available
May 23, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedJuly 19, 2022
May 1, 2022
8.5 years
October 12, 2005
December 10, 2015
June 28, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Treatment Completion
From registration to end of treatment; up to 64 days."
Complete Response to Treatment
At 12 weeks from treatment start
Progression-free Survival
From start of treatment to last follow-up. Maximum follow-up at time of analysis was 9.9 years.
Overall Survival
From the date of treatment started to death, assessed up to at least 5 years
Study Arms (2)
Group I (paclitaxel, trastuzumab, radiation therapy)
EXPERIMENTALPatients 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.
Group II (paclitaxel, radiation therapy)
EXPERIMENTALPatients 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.
Interventions
Given IV
Undergo radiation therapy
Given IV
Eligibility Criteria
You may qualify if:
- 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
- +23 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- National Cancer Institute (NCI)lead
- Radiation Therapy Oncology Groupcollaborator
Study Sites (184)
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 D.C., 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
University of Miami Miller School of Medicine-Sylvester Cancer Center
Miami, Florida, 33136, United States
Mount Sinai Medical Center
Miami Beach, Florida, 33140, 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
Mercy Hospital Springfield
Springfield, Missouri, 65804, United States
Washington University School of Medicine
St Louis, Missouri, 63110, 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
Utah Cancer Specialists-Salt Lake City
Salt Lake City, Utah, 84106, United States
LDS Hospital
Salt Lake City, Utah, 84143, United States
Saint George Regional Medical Center
St. George, Utah, 84770, 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 1Z2, Canada
Atlantic Health Sciences Corporation-Saint John Regional Hospital
Saint John, New Brunswick, E2L 4L2, Canada
London Regional Cancer Program
London, Ontario, N6A 4L6, Canada
McGill University Department of Oncology
Montreal, Quebec, H2W 1S6, Canada
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Accrual of patients with her2/neu overexpression stopped early due to unmet targeted accrual goals, with 22 subject accrued out of 40 planned.
Results Point of Contact
- Title
- Wendy Seiferheld, M.S.
- Organization
- NRG Oncology
Study Officials
- PRINCIPAL INVESTIGATOR
M. D Michaelson
Radiation Therapy Oncology Group
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 12, 2005
First Posted
October 13, 2005
Study Start
July 26, 2005
Primary Completion
February 5, 2014
Study Completion
May 20, 2022
Last Updated
July 19, 2022
Results First Posted
May 23, 2016
Record last verified: 2022-05