Know Cancer

forgot password

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
Open (Enrolling)
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


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.


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.

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

- 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 [Herceptin®])

- 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 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:


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:


Principal Investigator

M. Dror Michaelson

Investigator Role:

Principal Investigator

Investigator Affiliation:

Radiation Therapy Oncology Group


United States: Food and Drug Administration

Study ID:




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



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