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
PRIMARY OBJECTIVE:
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 TURB 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.
Interventional
Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Acute treatment-related toxicity
For each patient group, the number of patients will be tabulated by the type and grade of toxicity.
At least 90 days
Yes
M. Dror Michaelson
Principal Investigator
Radiation Therapy Oncology Group
United States: Food and Drug Administration
NCI-2009-00730
NCT00238420
July 2005
Name | Location |
---|---|
Cleveland Clinic Foundation | Cleveland, Ohio 44195 |
Medical University of South Carolina | Charleston, South Carolina 29425-0721 |
Beth Israel Deaconess Medical Center | Boston, Massachusetts 02215 |
Bronson Methodist Hospital | Kalamazoo, Michigan 49007 |
West Michigan Cancer Center | Kalamazoo, Michigan 49007-3731 |
Borgess Medical Center | Kalamazooaa, Michigan 49001 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
LDS Hospital | Salt Lake City, Utah 84143 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
University of Kansas Medical Center | Kansas City, Kansas 66160-7353 |
Boston Medical Center | Boston, Massachusetts 02118 |
Providence Alaska Medical Center | Anchorage, Alaska 99508 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Via Christi Regional Medical Center | Wichita, Kansas 67214 |
Wesley Medical Center | Wichita, Kansas 67214 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Iowa Methodist Medical Center | Des Moines, Iowa 50309 |
Iowa Lutheran Hospital | Des Moines, Iowa 50316-2301 |
Great Falls Clinic | Great Falls, Montana 59405 |
MetroHealth Medical Center | Cleveland, Ohio 44109 |
Cancer Center of Kansas - Dodge City | Dodge City, Kansas 67801 |
Cancer Center of Kansas - Salina | Salina, Kansas 67042 |
Cancer Center of Kansas - Wellington | Wellington, Kansas 67152 |
Associates in Womens Health | Wichita, Kansas 67203 |
Cancer Center of Kansas - Winfield | Winfield, Kansas 67156 |
Northern Rockies Radiation Oncology Center | Billings, Montana 59101 |
Big Sky Oncology | Great Falls, Montana 59405 |
Logan Regional Hospital | Logan, Utah 84321 |
Cottonwood Hospital Medical Center | Murray, Utah 84107 |
McKay-Dee Hospital Center | Ogden, Utah 84403 |
Welch Cancer Center | Sheridan, Wyoming 82801 |
University Medical Center of Southern Nevada | Las Vegas, Nevada 89102 |
Beebe Medical Center | Lewes, Delaware 19958 |
Memorial Hospital | Carthage, Illinois 62321 |
Galesburg Cottage Hospital | Galesburg, Illinois 61401 |
Galesburg Clinic | Galesburg, Illinois 61401 |
Mason District Hospital | Havana, Illinois 62644 |
Kewanee Hospital | Kewanee, Illinois 61443 |
McDonough District Hospital | Macomb, Illinois 61455 |
BroMenn Regional Medical Center | Normal, Illinois 61761 |
Proctor Hospital | Peoria, Illinois 61614 |
Perry Memorial Hospital | Princeton, Illinois 61356 |
Valley Cancer Center | Spring Valley, Illinois 61362 |
Bismarck Cancer Center | Bismarck, North Dakota 58501 |
Mercy Medical Center | Springfield, Ohio 45504 |
Danville Regional Medical Center | Danville, Virginia 24541 |
Eureka Hospital | Eureka, Illinois 61530 |
Valley Medical Center | Renton, Washington 98055 |
Graham Hospital Association | Canton, Illinois 61520 |
Holy Family Medical Center | Des Plaines, Illinois 60016 |
Saint Joseph Medical Center | Joliet, Illinois 60435 |
Pekin Hospital | Pekin, Illinois 61554 |
Medical Oncology and Hematology Associates | Des Moines, Iowa 50309 |
Cancer Treatment Center | Wooster, Ohio 44691 |
Lawrence Memorial Hospital | Lawrence, Kansas 66044 |
Bozeman Deaconess Cancer Center | Bozeman, Montana 59715 |
Singing River Hospital | Pascagoula, Mississippi 39581 |
Union Hospital of Cecil County | Elkton MD, Maryland 21921 |
Presbyterian Hospital | Charlotte, North Carolina 28233-3549 |
Memorial Medical Center | Springfield, Illinois 62781 |
Solano Radiation Oncology Center | Vacaville, California 95687 |
Cancer Care Center, Incorporated | Salem, Ohio 44460 |
Holy Cross Hospital | Fort Lauderdale, Florida 33308 |
Dartmouth Hitchcock Medical Center | Lebanon, New Hampshire 03756 |
Mid Dakota Clinic | Bismarck, North Dakota 58501 |
University of Texas Southwestern Medical Center | Dallas, Texas |
University of Kentucky | Lexington, Kentucky 40536-0098 |
Wichita CCOP | Wichita, Kansas 67214-3882 |
Montana Cancer Consortium CCOP | Billings, Montana 59101 |
Virginia Mason CCOP | Seattle, Washington 98101 |
Thomas Jefferson University Hospital | Philadelphia, Pennsylvania 19131 |
Decatur Memorial Hospital | Decatur, Illinois 62526 |
Providence Saint Joseph Medical Center | Burbank, California 91505-4866 |
Hudson Valley Oncology Associates | Poughkeepsie, New York 12601 |
OSF Saint Francis Medical Center | Peoria, Illinois 61637 |
Penrose-Saint Francis Healthcare | Colorado Springs, Colorado 80907 |
Lombardi Comprehensive Cancer Center at Georgetown University | Washington, District of Columbia 20057 |
M D Anderson Cancer Center- Orlando | Orlando, Florida 32806 |
Rush - Copley Medical Center | Aurora, Illinois 60504 |
Intercommunity Cancer Center | Galesburg, Illinois 61401 |
Hopedale Medical Complex - Hospital | Hopedale, Illinois 61747 |
Joliet Oncology-Hematology Associates Limited | Joliet, Illinois 60435 |
Community Cancer Center Foundation | Normal, Illinois 61761 |
Illinois CancerCare-Ottawa Clinic | Ottawa, Illinois 61350 |
Ottawa Regional Hospital and Healthcare Center | Ottawa, Illinois 61350 |
Pekin Cancer Treatment Center | Pekin, Illinois 61554 |
Illinois Oncology Research Association CCOP | Peoria, Illinois 61615 |
Illinois CancerCare-Peoria | Peoria, Illinois 61615 |
Illinois Valley Hospital | Peru, Illinois 61354 |
Saint Margaret's Hospital | Spring Valley, Illinois 61362 |
Carle Clinic-Urbana Main | Urbana, Illinois 61801 |
Saint Anthony Memorial Health Center | Michigan City, Indiana 46360 |
McFarland Clinic | Ames, Iowa 50010 |
Iowa Oncology Research Association CCOP | Des Moines, Iowa 50309 |
Mercy Capitol | Des Moines, Iowa 50307 |
Mercy Medical Center - Des Moines | Des Moines, Iowa 50314 |
Medical Oncology and Hematology Associates-Des Moines | Des Moines, Iowa 50309 |
Mercy Medical Center-Sioux City | Sioux City, Iowa 51104 |
Saint Luke's Regional Medical Center | Sioux City, Iowa 51104 |
Cancer Center of Kansas - El Dorado | El Dorado, Kansas 67042 |
Cancer Center of Kansas-Wichita Medical Arts Tower | Wichita, Kansas 67208 |
Cancer Center of Kansas - Main Office | Wichita, Kansas 67214 |
Saint John's Hospital | Springfield, Missouri 65804 |
Billings Clinic | Billings, Montana 59107-7000 |
Benefis Healthcare- Sletten Cancer Institute | Great Falls, Montana 59405 |
Berdeaux, Donald MD (UIA Investigator) | Great Falls, Montana 59405 |
Nevada Cancer Research Foundation CCOP | Las Vegas, Nevada 89106 |
Cheshire Medical Center-Dartmouth-Hitchcock Keene | Keene, New Hampshire 03431 |
Cooper Hospital University Medical Center | Camden, New Jersey 08103 |
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington County | Mount Holly, New Jersey 08060 |
South Jersey Healthcare | Vineland, New Jersey 08360 |
Kinston Medical Specialists PA | Kinston, North Carolina 28501 |
Saint Alexius Medical Center | Bismarck, North Dakota 58501 |
Summa Barberton Hospital | Barberton, Ohio 44203 |
Riddle Hospital | Media, Pennsylvania 19063 |
Saint Francis Hospital | Federal Way, Washington 98003 |
Evergreen Hospital Medical Center | Kirkland, Washington 98033 |
Good Samaritan Community Hospital | Puyallup, Washington 98372 |
Northwest CCOP | Tacoma, Washington 98405 |
Multicare Health System | Tacoma, Washington 98415 |
Saint Joseph Medical Center | Tacoma, Washington 98405 |
Northeast Radiation Oncology Center | Dunmore, Pennsylvania 18512 |
Radiological Associates of Sacramento | Sacramento, California 95816 |
Jupiter Medical Center | Jupiter, Florida 33458 |
Mount Sinai Medical Center CCOP | Miami Beach, Florida 33140 |
Illinois CancerCare-Bloomington | Bloomington%, Illinois 61701 |
Illinois CancerCare-Canton | Canton, Illinois 61520 |
Illinois CancerCare-Carthage | Carthage, Illinois 62321 |
Illinois CancerCare-Eureka | Eureka, Illinois 61530 |
Illinois CancerCare-Havana | Havana, Illinois 62644 |
Illinois CancerCare-Kewanee Clinic | Kewanee, Illinois 61443 |
Illinois CancerCare-Macomb | Macomb, Illinois 61455 |
Illinois CancerCare-Monmouth | Monmouth, Illinois 61462 |
Illinois CancerCare-Community Cancer Center | Normal, Illinois 61761 |
Illinois CancerCare-Pekin | Pekin, Illinois 61603 |
Illinois CancerCare-Peru | Peru, Illinois 61354 |
Illinois CancerCare-Princeton | Princeton, Illinois 61356 |
Illinois CancerCare-Spring Valley | Spring Valley, Illinois 61362 |
University of Michigan University Hospital | Ann Arbor, Michigan 48109 |
Sandra L Maxwell Cancer Center | Cedar City, Utah 84720 |
Intermountain Medical Center | Murray, Utah 84157 |
Utah Valley Regional Medical Center | Provo, Utah 84603 |
Dixie Medical Center Regional Cancer Center | Saint George, Utah 84770 |
Utah Cancer Specialists-Salt Lake City | Salt Lake City, Utah 84106 |
University of Miami Miller School of Medicine-Sylvester Cancer Center | Miami, Florida 33136 |
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CC | Peoria, Illinois 61615-7827 |
Siouxland Hematology Oncology Associates | Sioux City, Iowa 51101 |
Fox Chase Cancer Center Buckingham | Furlong, Pennsylvania 18925 |
UMDNJ - Robert Wood Johnson University Hospital | New Brunswick, New Jersey 08903 |
Radiation Oncology Associates PC | Fort Wayne, Indiana 46804 |
Summa Akron City Hospital | Akron, Ohio 44304 |
Sanford Bismarck Medical Center | Bismarck, North Dakota 58501 |
Christiana Care Health System-Christiana Hospital | Newark, Delaware 19718 |
Auburn Radiation Oncology Center | Auburn, California 95603 |
Marshall Radiation Oncology Center | Cameron Park, California 95682 |
Mercy San Juan Medical Center | Carmichael, California 95608 |
Roseville Radiation Oncology Center | Roseville, California 95661 |
Mercy General Hospital Radiation Oncology Center | Sacramento, California 95819 |
Parkview Hospital | Fort Wayne, Indiana 46805 |
Norris Cotton Cancer Center-North | Saint Johnsbury, Vermont 05819 |