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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Bladder Cancer

Thank you

Trial Information

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.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed stage II or III (T2-4a, Nx or N0, M0) primary carcinoma of
the bladder with muscle invasion

- Resectable disease

- Prostatic urethral involvement with transitional cell carcinoma allowed, if
completely resected and no evidence of stromal invasion

- No tumor-related hydronephrosis

- Positive lymph node must be evaluated by lymphadenectomy or percutaneous needle
biopsy

- No nodal metastases

- No distant metastases

- No more than 6 weeks since prior transurethral resection of the bladder tumor

- Functioning bladder

PATIENT CHARACTERISTICS:

Age:

- Adult

Performance status:

- Zubrod 0-1

Life expectancy:

- Not specified

Hematopoietic:

- Hemoglobin at least 10 g/dL

- WBC at least 4,000/mm^3

- Absolute neutrophil count at least 1,800/mm^3

- Platelet count at least 100,000/mm^3

Hepatic:

- Bilirubin no greater than 2.0 mg/dL

Renal:

- Creatinine no greater than 1.5 mg/dL

- Creatinine clearance at least 60 mL/min

Other:

- No other prior or concurrent malignancy within the past 5 years except curatively
treated nonmelanoma skin cancer, stage I prostate cancer, or carcinoma in situ of the
cervix

- Not pregnant

- Negative pregnancy test

- Fertile patients must use effective contraception

- Medically operable

PRIOR CONCURRENT THERAPY:

Biologic therapy:

- Not specified

Chemotherapy:

- No prior systemic chemotherapy

Endocrine therapy:

- Not specified

Radiotherapy:

- No prior pelvic radiotherapy

Surgery:

- See Disease Characteristics

Other:

- No concurrent potential nephrotoxic or ototoxic drugs (e.g., aminoglycosides)

Type of Study:

Interventional

Study Design:

Primary Purpose: Treatment

Principal Investigator

Donald S. Kaufman, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Federal Government

Study ID:

CDR0000067122

NCT ID:

NCT00003930

Start Date:

September 1999

Completion Date:

Related Keywords:

  • Bladder Cancer
  • stage II bladder cancer
  • stage III bladder cancer
  • Urinary Bladder Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
University of Texas - MD Anderson Cancer CenterHouston, Texas  77030-4009
University of Michigan Comprehensive Cancer CenterAnn Arbor, Michigan  48109-0752
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Jonsson Comprehensive Cancer Center, UCLALos Angeles, California  90095-1781
University of Colorado Cancer CenterDenver, Colorado  80262
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Emory University Hospital - AtlantaAtlanta, Georgia  30322
MBCCOP - HawaiiHonolulu, Hawaii  96813
Albert B. Chandler Medical Center, University of KentuckyLexington, Kentucky  40536-0084
CCOP - Ann Arbor RegionalAnn Arbor, Michigan  48106
Barbara Ann Karmanos Cancer InstituteDetroit, Michigan  48201
Cancer Center of Albany Medical CenterAlbany, New York  12208
State University of New York Health Science Center at BrooklynBrooklyn, New York  11203
University of Rochester Cancer CenterRochester, New York  14642
Lineberger Comprehensive Cancer Center, UNCChapel Hill, North Carolina  27599-7295
Barrett Cancer Center, The University HospitalCincinnati, Ohio  45219
Ireland Cancer CenterCleveland, Ohio  44106-5065
Arthur G. James Cancer Hospital - Ohio State UniversityColumbus, Ohio  43210
Milton S. Hershey Medical CenterHershey, Pennsylvania  17033
Kimmel Cancer Center of Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
University of Pennsylvania Cancer CenterPhiladelphia, Pennsylvania  19104
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
St. Luke's Medical CenterMilwaukee, Wisconsin  53215
Sylvester Cancer Center, University of MiamiMiami, Florida  33136
Hurley Medical CenterFlint, Michigan  48503
East Carolina University School of MedicineGreenville, North Carolina  27858-4354
Vermont Cancer CenterBurlington, Vermont  05401-3498
CCOP - Atlanta RegionalAtlanta, Georgia  30342-1701
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
UCSF Cancer Center and Cancer Research InstituteSan Francisco, California  94115-0128
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
Sinai Hospital of BaltimoreBaltimore, Maryland  21225
Ellis Fischel Cancer Center - ColumbiaColumbia, Missouri  65203
Norris Cotton Cancer CenterLebanon, New Hampshire  03756
CCOP - North Shore University HospitalManhasset, New York  11030
CCOP - Southeast Cancer Control ConsortiumWinston-Salem, North Carolina  27104-4241
University of Tennessee, Memphis Cancer CenterMemphis, Tennessee  38103
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15213
Bloomington HospitalBloomington, Indiana  47402
Geisinger Medical CenterDanville, Pennsylvania  17822-0001
Vanderbilt-Ingram Cancer CenterNashville, Tennessee  37232-6838
MD Anderson Cancer Center OrlandoOrlando, Florida  32806
Loyola University Medical CenterMaywood, Illinois  60153
CCOP - OchsnerNew Orleans, Louisiana  70121
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
CCOP - Toledo Community Hospital Oncology ProgramToledo, Ohio  43623-3456
Rapid City Regional HospitalRapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Comprehensive Cancer Center at Wake Forest UniversityWinston-Salem, North Carolina  27157-1082
Cancer Center at the University of VirginiaCharlottesville, Virginia  22908
Henry Ford HospitalDetroit, Michigan  48202
Marshfield ClinicMarshfield, Wisconsin  54449
Medical College of WisconsinMilwaukee, Wisconsin  53226
Huntsville Hospital SystemHuntsville, Alabama  35801
Alabama Oncology, LLCMontgomery, Alabama  36106-2801
Radiation Oncology Associates of West AlabamaTuscallosa, Alabama  35401
Mount Diablo Medical CenterConcord, California  94524-4110
California Cancer CenterFresno, California  93720
Saint Agnes Cancer CenterFresno, California  93720
Loma Linda University Medical CenterLoma Linda, California  92354
Veterans Affairs Medical Center - Long BeachLong Beach, California  90822
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Cancer Care CenterPomona, California  91767
Radiation Oncology Center - SacramentoSacramento, California  95816
O'Connor HospitalSan Jose, California  95128
CCOP - Santa Rosa Memorial HospitalSanta Rosa, California  95403
David Grant Medical CenterTravis Air Force Base, California  94535
Memorial Hospital Cancer CenterColorado Springs, Colorado  80909
University of Florida Health Science CenterGainesville, Florida  32610-0296
Health First Holmes Regional Medical CenterMelbourne, Florida  32901
Baptist Hospital of MiamiMiami, Florida  33176-2197
Florida Radiation Oncology GroupOrange Park, Florida  32073
Gulf Coast Cancer Treatment CenterPanama City, Florida  32405-4587
Sarasota Radiation and Medical Oncology CenterSarasota, Florida  34233
Medical Center/John B. Amos Community Cancer CenterColumbus, Georgia  31902
Northwest Community HospitalArlington Heights, Illinois  60005
Northwestern Memorial HospitalChicago, Illinois  60611
Ingalls Memorial HospitalHarvey, Illinois  60426
Lutheran General Cancer Care CenterPark Ridge, Illinois  60068
Methodist Medical Center of IllinoisPeoria, Illinois  61636
CCOP - Central IllinoisSpringfield, Illinois  62526
St. John's Medical CenterAnderson, Indiana  46016
Community Hospitals of Indianapolis - Regional Cancer CenterIndianapolis, Indiana  46219
Ball Memorial HospitalMuncie, Indiana  47303-3499
Wendt Regional Cancer Center of Finley HospitalDubuque, Iowa  52001
James Graham Brown Cancer CenterLouisville, Kentucky  40202
Louisville Radiation OncologyLouisville, Kentucky  40215
Merle M. Mahr Cancer CenterMadisonville, Kentucky  42431
Mary Bird Perkins Cancer CenterBaton Rouge, Louisiana  70809
Tulane University School of MedicineNew Orleans, Louisiana  70112
Maine Medical CenterPortland, Maine  04102
Anne Arundel Oncology CenterAnnapolis, Maryland  21401
Greater Baltimore Medical Center and Cancer CenterBaltimore, Maryland  21204
Harbor Hospital CenterBaltimore, Maryland  21225
Cape Cod HospitalHyannis, Massachusetts  02601
Veterans Affairs Medical Center - Boston (Jamaica Plain)Jamaica Plain, Massachusetts  02130
McLaren Regional Cancer CenterFlint, Michigan  48432
Marquette General HospitalMarquette, Michigan  49855
Mallinckrodt Institute of RadiologySaint Louis, Missouri  63110
St. Louis University Health Sciences CenterSaint Louis, Missouri  63110-0250
Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Cancer Research for the OzarksSpringfield, Missouri  65807
CCOP - Montana Cancer ConsortiumBillings, Montana  59101
Methodist Cancer Center - OmahaOmaha, Nebraska  68114
Elliot Regional Cancer CenterManchester, New Hampshire  03103
John F. Kennedy Medical CenterEdison, New Jersey  08818
Newark Beth Israel Medical CenterNewark, New Jersey  07112
Community Medical CenterToms River, New Jersey  08755
St. Francis Medical CenterTrenton, New Jersey  08629
New York Methodist HospitalBrooklyn, New York  11215-3609
Champlain Valley Physicians Hospital Medical CenterPlattsburgh, New York  12901
Vassar Brothers HospitalPoughkeepsie, New York  12601
Northeast Medical CenterConcord, North Carolina  28025
Akron General Medical CenterAkron, Ohio  44302
Christ HospitalCincinnati, Ohio  45219
University Hospitals of ClevelandCleveland, Ohio  44106
CCOP - ColumbusColumbus, Ohio  43206
CCOP - DaytonKettering, Ohio  45429
CCOP - Columbia River ProgramPortland, Oregon  97213
Lehigh Valley HospitalAllentown, Pennsylvania  18103
St. Luke's Hospital Regional Cancer CenterBethlehem, Pennsylvania  18015
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
Albert Einstein Cancer CenterPhiladelphia, Pennsylvania  19141
Veterans Affairs Medical Center - PhiladelphiaPhiladelphia, Pennsylvania  19104
Western Pennsylvania HospitalPittsburgh, Pennsylvania  15224
Mercy Hospital of PittsburghPittsburgh, Pennsylvania  15219
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
Mercy Hospital Cancer Center - ScrantonScranton, Pennsylvania  18501
Wilkes Barre General HospitalWilkes-Barre, Pennsylvania  18764
York HospitalYork, Pennsylvania  17315
Roger Williams Medical Center/BUSMProvidence, Rhode Island  02908-4735
CCOP - GreenvilleGreenville, South Carolina  29615
Jackson-Madison County General HospitalJackson, Tennessee  38301
Harrington Cancer CenterAmarillo, Texas  79106
University of Texas Medical BranchGalveston, Texas  77555-1329
Wilford Hall - 59th Medical WingLackland Air Force Base, Texas  78236-5300
Joe Arrington Cancer Research and Treatment CenterLubbock, Texas  79410-1894
Bayshore Medical CenterPasadena, Texas  77504
Dixie Regional Medical CenterSaint George, Utah  84770
Green Mountain Oncology GroupRutland, Vermont  05701
Naval Medical Center, PortsmouthPortsmouth, Virginia  23708-2197
Massey Cancer CenterRichmond, Virginia  23298-0037
Virginia Mason Medical CenterSeattle, Washington  98111
Deaconess Medical CenterSpokane, Washington  99210-0248
Yakima Valley Memorial HospitalYakima, Washington  98902
St. Vincent HospitalGreen Bay, Wisconsin  54307-3508
Gundersen Lutheran Medical FoundationLa Crosse, Wisconsin  54601
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Southern Wisconsin Radiotherapy CenterMadison, Wisconsin  53713
Community Memorial HospitalMenomonee Falls, Wisconsin  53051
Columbia HospitalMilwaukee, Wisconsin  53211
Southeastern Wisconsin Regional Cancer CenterRacine, Wisconsin  53405
Waukesha Memorial HospitalWaukesha, Wisconsin  53188
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
MBCCOP - Gulf CoastMobile, Alabama  36688
Cancer Center and Beckman Research Institute, City of HopeDuarte, California  91010-3000
USC/Norris Comprehensive Cancer Center and HospitalLos Angeles, California  90033-0804
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
Herbert Irving Comprehensive Cancer CenterNew York, New York  10032
CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.Syracuse, New York  13217
Comprehensive Cancer Institute of HuntsvilleHuntsville, Alabama  35801
Foundation for Cancer Research and EducationPhoenix, Arizona  85013
Radiation Medical Group, Inc.San Diego, California  92101-1492
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Bay Medical CenterPanama City, Florida  32401
Tallahassee Memorial HealthcareTallahassee, Florida  32308
Peninsula Regional Medical CenterSalisbury, Maryland  21801
MidMichigan Medical Center - MidlandMidland, Michigan  48670
William Beaumont HospitalRoyal Oak, Michigan  48073
Nebraska Health SystemOmaha, Nebraska  68105-1018
Trinitas Hospital - Jersey Street CampusElizabeth, New Jersey  07201
Monmouth Medical CenterLong Branch, New Jersey  07740-6395
South Jersey Regional Cancer CenterMillville, New Jersey  08332
Fox Chase Cancer Center at Virtua Memorial Hospital Burlington CountyMount Holly, New Jersey  08060
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Atlantic City Medical CenterPomona, New Jersey  08240
Associated Radiologists, P.A.Warren, New Jersey  07059
St. Anthony HospitalOklahoma City, Oklahoma  73101
St. John Health SystemTulsa, Oklahoma  74104
University of Utah Health Sciences CenterSalt Lake City, Utah  84132
Schiffler Cancer CenterWheeling, West Virginia  26003
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Cooper Cancer InstituteCamden, New Jersey  08103
Sutter Health West Cancer Research GroupGreenbrae, California  94904
Huntington Cancer CenterPasadena, California  91105
Saint Mary's Hospital and Medical CenterGrand Junction, Colorado  81502-1628
Regional Radiation Oncology Center at RomeRome, Georgia  30165
Clarian Health Partners Inc.Indianapolis, Indiana  46206-1367
Central Baptist HospitalLexington, Kentucky  40503
William Beaumont Hospital - TroyTroy, Michigan  48098
Valley HospitalRidgewood, New Jersey  07450
Radiation Oncology Associates of AlbuquerqueAlbuquerque, New Mexico  87109
Finger Lakes Radiation Oncology CenterClifton Springs, New York  14432
Riverhill Radiation OncologyYonkers, New York  10701
Trinity Cancer Care CenterMinot, North Dakota  58701
Pocono Cancer CenterEast Stroudsburg, Pennsylvania  18301
Latter Day Saints HospitalSalt Lake City, Utah  84143
RMH Regional Cancer CenterHarrisonburg, Virginia  22801
Bon-Secours - St. Mary's HospitalRichmond, Virginia  23226
Fitzgerald Mercy HospitalDarby, Pennsylvania  19023