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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


Phase 1/Phase 2
18 Years
N/A
Open (Enrolling)
Both
Stage I Bladder Cancer, Stage II Bladder Cancer, Stage III Bladder Cancer, Transitional Cell Carcinoma of the Bladder

Thank you

Trial Information

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 (HerceptinĀ®) 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.


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

- SGOT and SGPT < 2.5 times upper limit of normal

- No hepatic insufficiency resulting in clinical jaundice and/or coagulation defects

- Creatinine =< 3.0 mg/dL

- LVEF >= 40% by 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 [HerceptinĀ®])

- 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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Acute treatment-related toxicity

Outcome Description:

For each patient group, the number of patients will be tabulated by the type and grade of toxicity.

Outcome Time Frame:

At least 90 days

Safety Issue:

Yes

Principal Investigator

M. Dror Michaelson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Therapy Oncology Group

Authority:

United States: Food and Drug Administration

Study ID:

NCI-2009-00730

NCT ID:

NCT00238420

Start Date:

July 2005

Completion Date:

Related Keywords:

  • Stage I Bladder Cancer
  • Stage II Bladder Cancer
  • Stage III Bladder Cancer
  • Transitional Cell Carcinoma of the Bladder
  • Urinary Bladder Neoplasms
  • Carcinoma
  • Carcinoma, Transitional Cell

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Medical University of South CarolinaCharleston, South Carolina  29425-0721
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Methodist Medical Center of IllinoisPeoria, Illinois  61636
Delaware County Memorial HospitalDrexel Hill, Pennsylvania  19026
LDS HospitalSalt Lake City, Utah  84143
Virginia Mason Medical CenterSeattle, Washington  98111
University of Kansas Medical CenterKansas City, Kansas  66160-7353
Boston Medical CenterBoston, Massachusetts  02118
Providence Alaska Medical CenterAnchorage, Alaska  99508
Cancer Institute of New JerseyNew Brunswick, New Jersey  08901
Via Christi Regional Medical CenterWichita, Kansas  67214
Wesley Medical CenterWichita, Kansas  67214
University of Oklahoma Health Sciences CenterOklahoma City, Oklahoma  73104
Iowa Methodist Medical CenterDes Moines, Iowa  50309
Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Great Falls ClinicGreat Falls, Montana  59405
MetroHealth Medical CenterCleveland, Ohio  44109
Cancer Center of Kansas - Dodge CityDodge City, Kansas  67801
Cancer Center of Kansas - SalinaSalina, Kansas  67042
Cancer Center of Kansas - WellingtonWellington, Kansas  67152
Associates in Womens HealthWichita, Kansas  67203
Cancer Center of Kansas - WinfieldWinfield, Kansas  67156
Northern Rockies Radiation Oncology CenterBillings, Montana  59101
Big Sky OncologyGreat Falls, Montana  59405
Logan Regional HospitalLogan, Utah  84321
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Welch Cancer CenterSheridan, Wyoming  82801
University Medical Center of Southern NevadaLas Vegas, Nevada  89102
Beebe Medical CenterLewes, Delaware  19958
Memorial HospitalCarthage, Illinois  62321
Galesburg Cottage HospitalGalesburg, Illinois  61401
Galesburg ClinicGalesburg, Illinois  61401
Mason District HospitalHavana, Illinois  62644
Kewanee HospitalKewanee, Illinois  61443
McDonough District HospitalMacomb, Illinois  61455
BroMenn Regional Medical CenterNormal, Illinois  61761
Proctor HospitalPeoria, Illinois  61614
Perry Memorial HospitalPrinceton, Illinois  61356
Valley Cancer CenterSpring Valley, Illinois  61362
Bismarck Cancer CenterBismarck, North Dakota  58501
Mercy Medical CenterSpringfield, Ohio  45504
Danville Regional Medical CenterDanville, Virginia  24541
Eureka HospitalEureka, Illinois  61530
Valley Medical CenterRenton, Washington  98055
Graham Hospital AssociationCanton, Illinois  61520
Holy Family Medical CenterDes Plaines, Illinois  60016
Saint Joseph Medical CenterJoliet, Illinois  60435
Pekin HospitalPekin, Illinois  61554
Medical Oncology and Hematology AssociatesDes Moines, Iowa  50309
Cancer Treatment CenterWooster, Ohio  44691
Lawrence Memorial HospitalLawrence, Kansas  66044
Bozeman Deaconess Cancer CenterBozeman, Montana  59715
Singing River HospitalPascagoula, Mississippi  39581
Union Hospital of Cecil CountyElkton MD, Maryland  21921
Presbyterian HospitalCharlotte, North Carolina  28233-3549
Memorial Medical CenterSpringfield, Illinois  62781
Solano Radiation Oncology CenterVacaville, California  95687
Cancer Care Center, IncorporatedSalem, Ohio  44460
Holy Cross HospitalFort Lauderdale, Florida  33308
Dartmouth Hitchcock Medical CenterLebanon, New Hampshire  03756
Mid Dakota ClinicBismarck, North Dakota  58501
University of Texas Southwestern Medical CenterDallas, Texas  
University of KentuckyLexington, Kentucky  40536-0098
Wichita CCOPWichita, Kansas  67214-3882
Montana Cancer Consortium CCOPBillings, Montana  59101
Virginia Mason CCOPSeattle, Washington  98101
Thomas Jefferson University HospitalPhiladelphia, Pennsylvania  19131
Decatur Memorial HospitalDecatur, Illinois  62526
Providence Saint Joseph Medical CenterBurbank, California  91505-4866
Hudson Valley Oncology AssociatesPoughkeepsie, New York  12601
OSF Saint Francis Medical CenterPeoria, Illinois  61637
Penrose-Saint Francis HealthcareColorado Springs, Colorado  80907
Lombardi Comprehensive Cancer Center at Georgetown UniversityWashington, District of Columbia  20057
M D Anderson Cancer Center- OrlandoOrlando, Florida  32806
Rush - Copley Medical CenterAurora, Illinois  60504
Intercommunity Cancer CenterGalesburg, Illinois  61401
Hopedale Medical Complex - HospitalHopedale, Illinois  61747
Joliet Oncology-Hematology Associates LimitedJoliet, Illinois  60435
Community Cancer Center FoundationNormal, Illinois  61761
Illinois CancerCare-Ottawa ClinicOttawa, Illinois  61350
Ottawa Regional Hospital and Healthcare CenterOttawa, Illinois  61350
Pekin Cancer Treatment CenterPekin, Illinois  61554
Illinois Oncology Research Association CCOPPeoria, Illinois  61615
Illinois CancerCare-PeoriaPeoria, Illinois  61615
Illinois Valley HospitalPeru, Illinois  61354
Saint Margaret's HospitalSpring Valley, Illinois  61362
Carle Clinic-Urbana MainUrbana, Illinois  61801
Saint Anthony Memorial Health CenterMichigan City, Indiana  46360
McFarland ClinicAmes, Iowa  50010
Iowa Oncology Research Association CCOPDes Moines, Iowa  50309
Mercy CapitolDes Moines, Iowa  50307
Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Medical Oncology and Hematology Associates-Des MoinesDes Moines, Iowa  50309
Mercy Medical Center-Sioux CitySioux City, Iowa  51104
Saint Luke's Regional Medical CenterSioux City, Iowa  51104
Cancer Center of Kansas - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas-Wichita Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas - Main OfficeWichita, Kansas  67214
Saint John's HospitalSpringfield, Missouri  65804
Billings ClinicBillings, Montana  59107-7000
Benefis Healthcare- Sletten Cancer InstituteGreat Falls, Montana  59405
Berdeaux, Donald MD (UIA Investigator)Great Falls, Montana  59405
Nevada Cancer Research Foundation CCOPLas Vegas, Nevada  89106
Cheshire Medical Center-Dartmouth-Hitchcock KeeneKeene, New Hampshire  03431
Cooper Hospital University Medical CenterCamden, New Jersey  08103
Fox Chase Cancer Center at Virtua Memorial Hospital of Burlington CountyMount Holly, New Jersey  08060
South Jersey HealthcareVineland, New Jersey  08360
Kinston Medical Specialists PAKinston, North Carolina  28501
Saint Alexius Medical CenterBismarck, North Dakota  58501
Summa Barberton HospitalBarberton, Ohio  44203
Riddle HospitalMedia, Pennsylvania  19063
Saint Francis HospitalFederal Way, Washington  98003
Evergreen Hospital Medical CenterKirkland, Washington  98033
Good Samaritan Community HospitalPuyallup, Washington  98372
Northwest CCOPTacoma, Washington  98405
Multicare Health SystemTacoma, Washington  98415
Saint Joseph Medical CenterTacoma, Washington  98405
Northeast Radiation Oncology CenterDunmore, Pennsylvania  18512
Radiological Associates of SacramentoSacramento, California  95816
Jupiter Medical CenterJupiter, Florida  33458
Mount Sinai Medical Center CCOPMiami Beach, Florida  33140
Illinois CancerCare-BloomingtonBloomington%, Illinois  61701
Illinois CancerCare-CantonCanton, Illinois  61520
Illinois CancerCare-CarthageCarthage, Illinois  62321
Illinois CancerCare-EurekaEureka, Illinois  61530
Illinois CancerCare-HavanaHavana, Illinois  62644
Illinois CancerCare-Kewanee ClinicKewanee, Illinois  61443
Illinois CancerCare-MacombMacomb, Illinois  61455
Illinois CancerCare-MonmouthMonmouth, Illinois  61462
Illinois CancerCare-Community Cancer CenterNormal, Illinois  61761
Illinois CancerCare-PekinPekin, Illinois  61603
Illinois CancerCare-PeruPeru, Illinois  61354
Illinois CancerCare-PrincetonPrinceton, Illinois  61356
Illinois CancerCare-Spring ValleySpring Valley, Illinois  61362
University of Michigan University HospitalAnn Arbor, Michigan  48109
Sandra L Maxwell Cancer CenterCedar City, Utah  84720
Intermountain Medical CenterMurray, Utah  84157
Utah Valley Regional Medical CenterProvo, Utah  84603
Dixie Medical Center Regional Cancer CenterSaint George, Utah  84770
Utah Cancer Specialists-Salt Lake CitySalt Lake City, Utah  84106
University of Miami Miller School of Medicine-Sylvester Cancer CenterMiami, Florida  33136
OSF Saint Francis Medical Center Radiation Oncology Service at the Central Illinois Comprehensive CCPeoria, Illinois  61615-7827
Siouxland Hematology Oncology AssociatesSioux City, Iowa  51101
Fox Chase Cancer Center BuckinghamFurlong, Pennsylvania  18925
UMDNJ - Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
Radiation Oncology Associates PCFort Wayne, Indiana  46804
Summa Akron City HospitalAkron, Ohio  44304
Sanford Bismarck Medical CenterBismarck, North Dakota  58501
Christiana Care Health System-Christiana HospitalNewark, Delaware  19718
Auburn Radiation Oncology CenterAuburn, California  95603
Marshall Radiation Oncology CenterCameron Park, California  95682
Mercy San Juan Medical CenterCarmichael, California  95608
Roseville Radiation Oncology CenterRoseville, California  95661
Mercy General Hospital Radiation Oncology CenterSacramento, California  95819
Parkview HospitalFort Wayne, Indiana  46805
Norris Cotton Cancer Center-NorthSaint Johnsbury, Vermont  05819