A Phase I/II Trial in Patients With Muscle-Invading Bladder Cancer of Transurethral Surgery Plus Taxol, Cisplatin and Bid Irradiation Followed by Either Selective Bladder Preservation or Radical Cystectomy and Adjuvant Chemotherapy
OBJECTIVES:
- Evaluate the safety and tolerability of induction chemoradiotherapy with paclitaxel and
cisplatin followed by selective bladder preservation or radical cystectomy and adjuvant
chemotherapy in patients with stage II or III muscle invasive carcinoma of the bladder
previously treated with transurethral tumor resection.
- Evaluate the efficacy of transurethral tumor resection and induction chemoradiotherapy
in achieving a complete response in this patient population.
- Assess the value of tumor parameters as prognostic factors for initial tumor response
and recurrence-free survival in this patient population.
OUTLINE: Four to six weeks after prior transurethral resection, patients receive induction
therapy comprising paclitaxel IV over 1 hour on days 1, 8, and 15, cisplatin IV over 1 hour
on days 1, 2, 8, 9, 15, and 16, and radiotherapy twice daily on days 1-5, 8-12, and 17.
Four weeks after induction therapy, patients undergo urologic evaluation. At 1-2 weeks after
evaluation, patients with complete response receive consolidation therapy comprising
paclitaxel IV over 1 hour on days 1 and 8, cisplatin IV over 1 hour on days 1, 2, 8, and 9,
and radiotherapy twice daily on days 1-5 and 8-10. Patients with poor tumor response undergo
a cystectomy.
At 12 weeks postconsolidation therapy or 8 weeks post radical cystectomy, patients receive
adjuvant chemotherapy comprising gemcitabine IV over 30-60 minutes followed by cisplatin IV
over 1 hour every 3 weeks. Treatment repeats every 4 weeks for 4 courses in the absence of
disease progression or unacceptable toxicity.
Patients are followed every 4 months for 1 year, every 6 months for 3 years, and then
annually thereafter.
PROJECTED ACCRUAL: A total of 84 patients will be accrued for this study within 3 years.
Interventional
Primary Purpose: Treatment
Donald S. Kaufman, MD
Study Chair
Massachusetts General Hospital
United States: Federal Government
CDR0000067122
NCT00003930
September 1999
Name | Location |
---|---|
Akron City Hospital | Akron, Ohio 44304 |
University of Texas - MD Anderson Cancer Center | Houston, Texas 77030-4009 |
University of Michigan Comprehensive Cancer Center | Ann Arbor, Michigan 48109-0752 |
Mayo Clinic Cancer Center | Rochester, Minnesota 55905 |
Jonsson Comprehensive Cancer Center, UCLA | Los Angeles, California 90095-1781 |
University of Colorado Cancer Center | Denver, Colorado 80262 |
H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
Emory University Hospital - Atlanta | Atlanta, Georgia 30322 |
MBCCOP - Hawaii | Honolulu, Hawaii 96813 |
Albert B. Chandler Medical Center, University of Kentucky | Lexington, Kentucky 40536-0084 |
CCOP - Ann Arbor Regional | Ann Arbor, Michigan 48106 |
Barbara Ann Karmanos Cancer Institute | Detroit, Michigan 48201 |
Cancer Center of Albany Medical Center | Albany, New York 12208 |
State University of New York Health Science Center at Brooklyn | Brooklyn, New York 11203 |
University of Rochester Cancer Center | Rochester, New York 14642 |
Lineberger Comprehensive Cancer Center, UNC | Chapel Hill, North Carolina 27599-7295 |
Barrett Cancer Center, The University Hospital | Cincinnati, Ohio 45219 |
Ireland Cancer Center | Cleveland, Ohio 44106-5065 |
Arthur G. James Cancer Hospital - Ohio State University | Columbus, Ohio 43210 |
Milton S. Hershey Medical Center | Hershey, Pennsylvania 17033 |
Kimmel Cancer Center of Thomas Jefferson University - Philadelphia | Philadelphia, Pennsylvania 19107 |
University of Pennsylvania Cancer Center | Philadelphia, Pennsylvania 19104 |
Fox Chase Cancer Center | Philadelphia, Pennsylvania 19111 |
CCOP - Upstate Carolina | Spartanburg, South Carolina 29303 |
St. Luke's Medical Center | Milwaukee, Wisconsin 53215 |
Sylvester Cancer Center, University of Miami | Miami, Florida 33136 |
Hurley Medical Center | Flint, Michigan 48503 |
East Carolina University School of Medicine | Greenville, North Carolina 27858-4354 |
Vermont Cancer Center | Burlington, Vermont 05401-3498 |
CCOP - Atlanta Regional | Atlanta, Georgia 30342-1701 |
CCOP - Kansas City | Kansas City, Missouri 64131 |
CCOP - Southern Nevada Cancer Research Foundation | Las Vegas, Nevada 89106 |
UCSF Cancer Center and Cancer Research Institute | San Francisco, California 94115-0128 |
CCOP - Christiana Care Health Services | Wilmington, Delaware 19899 |
CCOP - Mount Sinai Medical Center | Miami Beach, Florida 33140 |
Sinai Hospital of Baltimore | Baltimore, Maryland 21225 |
Ellis Fischel Cancer Center - Columbia | Columbia, Missouri 65203 |
Norris Cotton Cancer Center | Lebanon, New Hampshire 03756 |
CCOP - North Shore University Hospital | Manhasset, New York 11030 |
CCOP - Southeast Cancer Control Consortium | Winston-Salem, North Carolina 27104-4241 |
University of Tennessee, Memphis Cancer Center | Memphis, Tennessee 38103 |
Veterans Affairs Medical Center - Indianapolis (Roudebush) | Indianapolis, Indiana 46202 |
CCOP - Kalamazoo | Kalamazoo, Michigan 49007-3731 |
CCOP - Metro-Minnesota | Saint Louis Park, Minnesota 55416 |
Veterans Affairs Medical Center - East Orange | East Orange, New Jersey 07018-1095 |
University of Pittsburgh Cancer Institute | Pittsburgh, Pennsylvania 15213 |
Bloomington Hospital | Bloomington, Indiana 47402 |
Geisinger Medical Center | Danville, Pennsylvania 17822-0001 |
Vanderbilt-Ingram Cancer Center | Nashville, Tennessee 37232-6838 |
MD Anderson Cancer Center Orlando | Orlando, Florida 32806 |
Loyola University Medical Center | Maywood, Illinois 60153 |
CCOP - Ochsner | New Orleans, Louisiana 70121 |
Massachusetts General Hospital Cancer Center | Boston, Massachusetts 02114 |
CCOP - Toledo Community Hospital Oncology Program | Toledo, Ohio 43623-3456 |
Rapid City Regional Hospital | Rapid City, South Dakota 57709 |
University of Alabama at Birmingham Comprehensive Cancer Center | Birmingham, Alabama 35294-3300 |
Comprehensive Cancer Center at Wake Forest University | Winston-Salem, North Carolina 27157-1082 |
Cancer Center at the University of Virginia | Charlottesville, Virginia 22908 |
Henry Ford Hospital | Detroit, Michigan 48202 |
Marshfield Clinic | Marshfield, Wisconsin 54449 |
Medical College of Wisconsin | Milwaukee, Wisconsin 53226 |
Huntsville Hospital System | Huntsville, Alabama 35801 |
Alabama Oncology, LLC | Montgomery, Alabama 36106-2801 |
Radiation Oncology Associates of West Alabama | Tuscallosa, Alabama 35401 |
Mount Diablo Medical Center | Concord, California 94524-4110 |
California Cancer Center | Fresno, California 93720 |
Saint Agnes Cancer Center | Fresno, California 93720 |
Loma Linda University Medical Center | Loma Linda, California 92354 |
Veterans Affairs Medical Center - Long Beach | Long Beach, California 90822 |
CCOP - Bay Area Tumor Institute | Oakland, California 94609-3305 |
Cancer Care Center | Pomona, California 91767 |
Radiation Oncology Center - Sacramento | Sacramento, California 95816 |
O'Connor Hospital | San Jose, California 95128 |
CCOP - Santa Rosa Memorial Hospital | Santa Rosa, California 95403 |
David Grant Medical Center | Travis Air Force Base, California 94535 |
Memorial Hospital Cancer Center | Colorado Springs, Colorado 80909 |
University of Florida Health Science Center | Gainesville, Florida 32610-0296 |
Health First Holmes Regional Medical Center | Melbourne, Florida 32901 |
Baptist Hospital of Miami | Miami, Florida 33176-2197 |
Florida Radiation Oncology Group | Orange Park, Florida 32073 |
Gulf Coast Cancer Treatment Center | Panama City, Florida 32405-4587 |
Sarasota Radiation and Medical Oncology Center | Sarasota, Florida 34233 |
Medical Center/John B. Amos Community Cancer Center | Columbus, Georgia 31902 |
Northwest Community Hospital | Arlington Heights, Illinois 60005 |
Northwestern Memorial Hospital | Chicago, Illinois 60611 |
Ingalls Memorial Hospital | Harvey, Illinois 60426 |
Lutheran General Cancer Care Center | Park Ridge, Illinois 60068 |
Methodist Medical Center of Illinois | Peoria, Illinois 61636 |
CCOP - Central Illinois | Springfield, Illinois 62526 |
St. John's Medical Center | Anderson, Indiana 46016 |
Community Hospitals of Indianapolis - Regional Cancer Center | Indianapolis, Indiana 46219 |
Ball Memorial Hospital | Muncie, Indiana 47303-3499 |
Wendt Regional Cancer Center of Finley Hospital | Dubuque, Iowa 52001 |
James Graham Brown Cancer Center | Louisville, Kentucky 40202 |
Louisville Radiation Oncology | Louisville, Kentucky 40215 |
Merle M. Mahr Cancer Center | Madisonville, Kentucky 42431 |
Mary Bird Perkins Cancer Center | Baton Rouge, Louisiana 70809 |
Tulane University School of Medicine | New Orleans, Louisiana 70112 |
Maine Medical Center | Portland, Maine 04102 |
Anne Arundel Oncology Center | Annapolis, Maryland 21401 |
Greater Baltimore Medical Center and Cancer Center | Baltimore, Maryland 21204 |
Harbor Hospital Center | Baltimore, Maryland 21225 |
Cape Cod Hospital | Hyannis, Massachusetts 02601 |
Veterans Affairs Medical Center - Boston (Jamaica Plain) | Jamaica Plain, Massachusetts 02130 |
McLaren Regional Cancer Center | Flint, Michigan 48432 |
Marquette General Hospital | Marquette, Michigan 49855 |
Mallinckrodt Institute of Radiology | Saint Louis, Missouri 63110 |
St. Louis University Health Sciences Center | Saint Louis, Missouri 63110-0250 |
Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Cancer Research for the Ozarks | Springfield, Missouri 65807 |
CCOP - Montana Cancer Consortium | Billings, Montana 59101 |
Methodist Cancer Center - Omaha | Omaha, Nebraska 68114 |
Elliot Regional Cancer Center | Manchester, New Hampshire 03103 |
John F. Kennedy Medical Center | Edison, New Jersey 08818 |
Newark Beth Israel Medical Center | Newark, New Jersey 07112 |
Community Medical Center | Toms River, New Jersey 08755 |
St. Francis Medical Center | Trenton, New Jersey 08629 |
New York Methodist Hospital | Brooklyn, New York 11215-3609 |
Champlain Valley Physicians Hospital Medical Center | Plattsburgh, New York 12901 |
Vassar Brothers Hospital | Poughkeepsie, New York 12601 |
Northeast Medical Center | Concord, North Carolina 28025 |
Akron General Medical Center | Akron, Ohio 44302 |
Christ Hospital | Cincinnati, Ohio 45219 |
University Hospitals of Cleveland | Cleveland, Ohio 44106 |
CCOP - Columbus | Columbus, Ohio 43206 |
CCOP - Dayton | Kettering, Ohio 45429 |
CCOP - Columbia River Program | Portland, Oregon 97213 |
Lehigh Valley Hospital | Allentown, Pennsylvania 18103 |
St. Luke's Hospital Regional Cancer Center | Bethlehem, Pennsylvania 18015 |
Delaware County Memorial Hospital | Drexel Hill, Pennsylvania 19026 |
Albert Einstein Cancer Center | Philadelphia, Pennsylvania 19141 |
Veterans Affairs Medical Center - Philadelphia | Philadelphia, Pennsylvania 19104 |
Western Pennsylvania Hospital | Pittsburgh, Pennsylvania 15224 |
Mercy Hospital of Pittsburgh | Pittsburgh, Pennsylvania 15219 |
Reading Hospital and Medical Center | Reading, Pennsylvania 19612-6052 |
Mercy Hospital Cancer Center - Scranton | Scranton, Pennsylvania 18501 |
Wilkes Barre General Hospital | Wilkes-Barre, Pennsylvania 18764 |
York Hospital | York, Pennsylvania 17315 |
Roger Williams Medical Center/BUSM | Providence, Rhode Island 02908-4735 |
CCOP - Greenville | Greenville, South Carolina 29615 |
Jackson-Madison County General Hospital | Jackson, Tennessee 38301 |
Harrington Cancer Center | Amarillo, Texas 79106 |
University of Texas Medical Branch | Galveston, Texas 77555-1329 |
Wilford Hall - 59th Medical Wing | Lackland Air Force Base, Texas 78236-5300 |
Joe Arrington Cancer Research and Treatment Center | Lubbock, Texas 79410-1894 |
Bayshore Medical Center | Pasadena, Texas 77504 |
Dixie Regional Medical Center | Saint George, Utah 84770 |
Green Mountain Oncology Group | Rutland, Vermont 05701 |
Naval Medical Center, Portsmouth | Portsmouth, Virginia 23708-2197 |
Massey Cancer Center | Richmond, Virginia 23298-0037 |
Virginia Mason Medical Center | Seattle, Washington 98111 |
Deaconess Medical Center | Spokane, Washington 99210-0248 |
Yakima Valley Memorial Hospital | Yakima, Washington 98902 |
St. Vincent Hospital | Green Bay, Wisconsin 54307-3508 |
Gundersen Lutheran Medical Foundation | La Crosse, Wisconsin 54601 |
University of Wisconsin Comprehensive Cancer Center | Madison, Wisconsin 53792 |
Southern Wisconsin Radiotherapy Center | Madison, Wisconsin 53713 |
Community Memorial Hospital | Menomonee Falls, Wisconsin 53051 |
Columbia Hospital | Milwaukee, Wisconsin 53211 |
Southeastern Wisconsin Regional Cancer Center | Racine, Wisconsin 53405 |
Waukesha Memorial Hospital | Waukesha, Wisconsin 53188 |
CCOP - Northern Indiana CR Consortium | South Bend, Indiana 46601 |
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins | Baltimore, Maryland 21231-2410 |
Cleveland Clinic Taussig Cancer Center | Cleveland, Ohio 44195 |
MBCCOP - Gulf Coast | Mobile, Alabama 36688 |
Cancer Center and Beckman Research Institute, City of Hope | Duarte, California 91010-3000 |
USC/Norris Comprehensive Cancer Center and Hospital | Los Angeles, California 90033-0804 |
MBCCOP - LSU Health Sciences Center | New Orleans, Louisiana 70112 |
Herbert Irving Comprehensive Cancer Center | New York, New York 10032 |
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C. | Syracuse, New York 13217 |
Comprehensive Cancer Institute of Huntsville | Huntsville, Alabama 35801 |
Foundation for Cancer Research and Education | Phoenix, Arizona 85013 |
Radiation Medical Group, Inc. | San Diego, California 92101-1492 |
Veterans Affairs Medical Center - Miami | Miami, Florida 33125 |
Bay Medical Center | Panama City, Florida 32401 |
Tallahassee Memorial Healthcare | Tallahassee, Florida 32308 |
Peninsula Regional Medical Center | Salisbury, Maryland 21801 |
MidMichigan Medical Center - Midland | Midland, Michigan 48670 |
William Beaumont Hospital | Royal Oak, Michigan 48073 |
Nebraska Health System | Omaha, Nebraska 68105-1018 |
Trinitas Hospital - Jersey Street Campus | Elizabeth, New Jersey 07201 |
Monmouth Medical Center | Long Branch, New Jersey 07740-6395 |
South Jersey Regional Cancer Center | Millville, New Jersey 08332 |
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington County | Mount Holly, New Jersey 08060 |
Cancer Institute of New Jersey | New Brunswick, New Jersey 08901 |
Atlantic City Medical Center | Pomona, New Jersey 08240 |
Associated Radiologists, P.A. | Warren, New Jersey 07059 |
St. Anthony Hospital | Oklahoma City, Oklahoma 73101 |
St. John Health System | Tulsa, Oklahoma 74104 |
University of Utah Health Sciences Center | Salt Lake City, Utah 84132 |
Schiffler Cancer Center | Wheeling, West Virginia 26003 |
University of Oklahoma Health Sciences Center | Oklahoma City, Oklahoma 73104 |
Cooper Cancer Institute | Camden, New Jersey 08103 |
Sutter Health West Cancer Research Group | Greenbrae, California 94904 |
Huntington Cancer Center | Pasadena, California 91105 |
Saint Mary's Hospital and Medical Center | Grand Junction, Colorado 81502-1628 |
Regional Radiation Oncology Center at Rome | Rome, Georgia 30165 |
Clarian Health Partners Inc. | Indianapolis, Indiana 46206-1367 |
Central Baptist Hospital | Lexington, Kentucky 40503 |
William Beaumont Hospital - Troy | Troy, Michigan 48098 |
Valley Hospital | Ridgewood, New Jersey 07450 |
Radiation Oncology Associates of Albuquerque | Albuquerque, New Mexico 87109 |
Finger Lakes Radiation Oncology Center | Clifton Springs, New York 14432 |
Riverhill Radiation Oncology | Yonkers, New York 10701 |
Trinity Cancer Care Center | Minot, North Dakota 58701 |
Pocono Cancer Center | East Stroudsburg, Pennsylvania 18301 |
Latter Day Saints Hospital | Salt Lake City, Utah 84143 |
RMH Regional Cancer Center | Harrisonburg, Virginia 22801 |
Bon-Secours - St. Mary's Hospital | Richmond, Virginia 23226 |
Fitzgerald Mercy Hospital | Darby, Pennsylvania 19023 |