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Last Modified: 8/19/2008     First Published: 9/16/2005  
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Phase I/II Study of Paclitaxel and Radiotherapy With or Without Trastuzumab (Herceptin®) in Patients Who Have Undergone Prior Transurethral Bladder Resection for Muscle-Invasive Transitional Cell Carcinoma of the Bladder

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Related Information
Registry Information

Alternate Title

Paclitaxel and Radiation Therapy With or Without Trastuzumab in Treating Patients Who Have Undergone Surgery for Bladder Cancer

Basic Trial Information

Phase
Type
Status
Age
Sponsor
Protocol IDs

Phase II, Phase I


Treatment


Active


18 and over


NCI


RTOG-0524
RTOG-0524, NCT00238420

Special Category: NCI Web site featured trial

Objectives

Primary

  1. Determine the acute toxicity of paclitaxel and radiotherapy with or without trastuzumab (Herceptin®) in patients who have undergone prior transurethral bladder resection for muscle-invasive transitional cell carcinoma of the bladder.

Secondary

  1. Determine the ability of these patients to complete these regimens.
  2. Determine the efficacy of these regimens, in terms of achieving a complete response of the primary tumor, in these patients.
  3. Determine the 5-year disease-free and overall survival of patients treated with these regimens.
  4. Determine the value of tumor and/or serum biomarkers as predictors of initial tumor response and recurrence-free survival of patients treated with these regimens.

Entry Criteria

Disease Characteristics:

  • Histologically or cytologically confirmed primary transitional cell carcinoma (TCC) of the bladder within the past 12 weeks
    • 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 CT scan AND abdominal/pelvic CT scan


  • 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


Prior/Concurrent Therapy:

Biologic therapy

  • Not specified

Chemotherapy

  • No prior systemic chemotherapy with anthracyclines or taxanes
  • No prior systemic chemotherapy for TCC

Endocrine therapy

  • Not specified

Radiotherapy

  • No prior pelvic radiotherapy

Surgery

  • See Disease Characteristics

Patient Characteristics:

Age

  • 18 and over

Performance status

  • Zubrod 0-2

Life expectancy

  • Not specified

Hematopoietic

  • Absolute neutrophil count ≥ 1,800/mm3
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 8.0 g/dL (transfusion or other intervention allowed)

Hepatic

  • 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

Renal

  • Creatinine ≤ 3.0 mg/dL

Cardiovascular

  • 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

Other

  • 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 AIDS
  • No other severe active comorbidity

Expected Enrollment

88

A total of 88 patients (44 per treatment group) will be accrued for this study within approximately 3 years.

Outcomes

Primary Outcome(s)

Safety during weekly treatment

Secondary Outcome(s)

Complete response rate by cystoscopy at 12 weeks

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 1: Patients receive paclitaxel IV over 1 hour and trastuzumab IV over 30-90 minutes on days 1, 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 2: 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 2 years, every 6 months for 3 years, and then annually thereafter.

Trial Contact Information

Trial Lead Organizations

Radiation Therapy Oncology Group

M. Dror Michaelson, MD, PhD, Protocol chair
Ph: 617-726-1594; 877-726-5130
Alan Pollack, MD, PhD, Protocol co-chair
Ph: 215-728-2940; 888-369-2427
Email: alan.pollack@fccc.edu
Douglas Dahl, MD, Protocol co-chair
Ph: 617-726-0874; 877-726-5130
Email: ddahl@partners.org

Trial Sites

U.S.A.
Alaska
  Anchorage
 Providence Cancer Center
 Clinical Trials Office - Providence Cancer Center
Ph: 907-261-3109
California
  Auburn
 Auburn Radiation Oncology
 Christopher Jones, MD
Ph: 916-888-1266
  Burbank
 Providence Saint Joseph Medical Center - Burbank
 Clinical Trials Office - Providence Saint Joseph Medical Center - Burbank
Ph: 818-847-3220
  Cameron Park
 Radiation Oncology Centers - Cameron Park
 Christopher Jones, MD
Ph: 916-622-9700
  Carmichael
 Mercy Cancer Center at Mercy San Juan Medical Center
 Christopher Jones, MD
Ph: 916-904-3440
  Roseville
 Radiation Oncology Center - Roseville
 Christopher Jones, MD
Ph: 916-969-4422
  Sacramento
 Mercy General Hospital
 Christopher Jones, MD
Ph: 916-453-4453
 Radiological Associates of Sacramento Medical Group, Incorporated
 Christopher Jones, MD
Ph: 916-646-8300
  Vacaville
 Solano Radiation Oncology Center
 Christopher Jones, MD
Ph: 707-447-0400
Colorado
  Colorado Springs
 Penrose Cancer Center at Penrose Hospital
 Clinical Trials Office - Penrose Cancer Center
Ph: 719-776-5275
Delaware
  Newark
 CCOP - Christiana Care Health Services
 Clinical Trial Office - CCOP - Christiana Care Health Services
Ph: 302-733-6227
District of Columbia
  Washington
 Lombardi Comprehensive Cancer Center at Georgetown University Medical Center
 Clinical Trials Office - Lombardi Comprehensive Cancer Center
Ph: 202-444-0381
Florida
  Panama City
 Bay Medical
 R. Charles Nichols, MD
Ph: 850-763-0036
Illinois
  Aurora
 Rush-Copley Cancer Care Center
 Kendrith Rowland, MD
Ph: 217-383-3010
  Bloomington
 St. Joseph Medical Center
 John Kugler, MD
Ph: 309-243-3000
  Decatur
 Decatur Memorial Hospital Cancer Care Institute
 Clinical Trials Office - Decatur Memorial Hospital Cancer Care Institute
Ph: 217-876-6601
  Galesburg
 InterCommunity Cancer Center of Western Illinois
 John Kugler, MD
Ph: 309-243-3000
  Joliet
 Joliet Oncology-Hematology Associates, Limited - West
 Kendrith Rowland, MD
Ph: 217-383-3010
  Normal
 BroMenn Regional Medical Center
 John Kugler, MD
Ph: 309-243-3000
 Community Cancer Center
 John Kugler, MD
Ph: 309-243-3000
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John Kugler, MD
Ph: 309-243-3000
  Peoria
 CCOP - Illinois Oncology Research Association
 John Kugler, MD
Ph: 309-243-3000
 Methodist Medical Center of Illinois
 Clinical Trials Office - Methodist Medical Center of Illinois
Ph: 309-243-3000
 Oncology Hematology Associates of Central Illinois, PC - Peoria
 John Kugler, MD
Ph: 309-243-3000
 OSF St. Francis Medical Center
 John Kugler, MD
Ph: 309-243-3000
  Spring Valley
 Valley Cancer Center
 John Kugler, MD
Ph: 309-243-3000
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
  Urbana
 Carle Cancer Center at Carle Foundation Hospital
 Clinical Trials Office - Carle Cancer Center
Ph: 800-446-5532
 CCOP - Carle Cancer Center
 Clinical Trials Office - CCOP - Carle Cancer Center
Ph: 800-446-5532
Indiana
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Tony Lee
Ph: 260-373-7850
 Radiation Oncology Associates Southwest
 Tony Lee
Ph: 260-436-4116
  Michigan City
 Saint Anthony Memorial Health Centers
 Kendrith Rowland, MD
Ph: 217-383-3010
Iowa
  Ames
 McFarland Clinic, PC
 Clinical Trials Office - McFarland Clinic, PC
Ph: 515-239-2621
  Des Moines
 CCOP - Iowa Oncology Research Association
 Roscoe Morton, MD, FACP
Ph: 515-244-7586
 John Stoddard Cancer Center at Iowa Lutheran Hospital
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Lutheran Hospital
Ph: 515-241-8704
 John Stoddard Cancer Center at Iowa Methodist Medical Center
 Clinical Trials Office - John Stoddard Cancer Center at Iowa Methodist Medical Center
Ph: 515-241-6727
 Medical Oncology and Hematology Associates at John Stoddard Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-244-7586
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-244-7586
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Roscoe Morton, MD, FACP
Ph: 515-244-7586
 Mercy Capitol Hospital
 Roscoe Morton, MD, FACP
Ph: 515-244-7586
  Sioux City
 Siouxland Hematology-Oncology Associates, LLP
 Donald Wender, MD, PhD
Ph: 712-252-9326
Kansas
  Kansas City
 Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
 Clinical Trials Office - Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
Ph: 913-588-4709
  Wichita
 Wesley Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Kentucky
  Lexington
 Lucille P. Markey Cancer Center at University of Kentucky
 Clinical Trials Office - Markey Cancer Center at University of Kentucky Chandler Medical Center
Ph: 859-257-3379
Massachusetts
  Boston
 Beth Israel Deaconess Medical Center
 Clinical Trials Office - Beth Israel Deaconess Medical Center
Ph: 617-667-9925
 Boston University Cancer Research Center
 Clinical Trials Office - Boston University Cancer Research Center
Ph: 617-353-7571
 Massachusetts General Hospital
 Clinical Trials Office - Massachusetts General Hospital
Ph: 877-726-5130
  Fall River
 Hudner Oncology Center at Saint Anne's Hospital - Fall River
 Clinical Trials Office - Hudner Oncology Center at Saint Anne's Hospital - Fall River
Ph: 508-674-5600 ext. 2019
Michigan
  Ann Arbor
 University of Michigan Comprehensive Cancer Center
 Clinical Trials Office - University of Michigan Comprehensive Cancer Center
Ph: 800-865-1125
  Kalamazoo
 Borgess Medical Center
 Raymond Lord, MD
Ph: 269-373-7488
 Bronson Methodist Hospital
 Raymond Lord, MD
Ph: 269-373-7488
 West Michigan Cancer Center
 Clinical Trials Office - West Michigan Cancer Center
Ph: 269-373-7458
Missouri
  Springfield
 St. John's Regional Health Center
 Robert Carolla
Ph: 417-820-2000
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Ellerton, MD, CM
Ph: 702-384-0013
 Nevada Cancer Institute
 Clinical Trials Office - Nevada Cancer Institute
Ph: 702-822-5136
New Hampshire
  Keene
 Kingsbury Center for Cancer Care at Cheshire Medical Center
 Alan Hartford, MD, PhD
Ph: 603-354-5400
  Lebanon
 Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
 Clinical Trials Office - Norris Cotton Cancer Center
Ph: 603-650-7609
 Email: cancerhelp@dartmouth.edu
New Jersey
  Marlton
 Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
 Clinical Trials Office - Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital Marlton
Ph: 888-847-8823
  New Brunswick
 Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School
 Clinical Trials Office - Cancer Institute of New Jersey
Ph: 732-235-8675
  Vineland
 Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
 Clinical Trials Office - Franklin & Edith Scarpa Regional Cancer Center at South Jersey Healthcare
Ph: 856-641-7933
  Voorhees
 Cancer Institute of New Jersey at Cooper - Voorhees
 Clinical Trials Office - Cancer Institute of New Jersey at Cooper University Hospital - Voorhees
Ph: 856-325-6757
North Carolina
  Charlotte
 Presbyterian Cancer Center at Presbyterian Hospital
 Clinical Trials Office - Presbyterian Cancer Center at Presbyterian Hospital
Ph: 704-384-5369
  Kinston
 Kinston Medical Specialists
 Peter Watson, MD
Ph: 252-559-2200 ext. 201
North Dakota
  Bismarck
 Bismarck Cancer Center
 Edward Wos, DO
Ph: 701-323-5741
 Medcenter One Hospital Cancer Care Center
 Edward Wos, DO
Ph: 701-323-5741
 Mid Dakota Clinic, PC
 Clinical Trials Office - Mid Dakota Clinic, PC
Ph: 701-530-6950
 St. Alexius Medical Center Cancer Center
 Clinical Trials Office - St. Alexius Medical Center Cancer Center
Ph: 701-530-6950
Ohio
  Akron
 McDowell Cancer Center at Akron General Medical Center
 Mitchell Fromm, MD
Ph: 330-344-6448
 Summa Center for Cancer Care at Akron City Hospital
 Clinical Trials Office - Akron City Hospital
Ph: 330-375-6101
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence Herman
Pennsylvania
  Drexel Hill
 Delaware County Regional Cancer Center at Delaware County Memorial Hospital
 Rachelle Lanciano, MD
Ph: 610-284-8240
  Philadelphia
 Fox Chase Cancer Center - Philadelphia
 Clinical Trials Office - Fox Chase Cancer Center - Philadelphia
Ph: 215-728-4790
 Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
 Clinical Trials Office - Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
Ph: 215-955-6084
South Carolina
  Charleston
 Hollings Cancer Center at Medical University of South Carolina
 Clinical Trials Office - Hollings Cancer Center at Medical University of South Carolina
Ph: 843-792-9321
Utah
  Cedar City
 Sandra L. Maxwell Cancer Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Murray
 Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
  Ogden
 Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
 Clinical Trials Office - McKay-Dee Hospital Center
Ph: 801 387-7426
  Provo
 Utah Valley Regional Medical Center - Provo
 Clinical Trials Office - Utah Valley Regional Medical Center - Provo
Ph: 801-357-7965
  Saint George
 Dixie Regional Medical Center - East Campus
 Clinical Trials Office - Dixie Regional Medical Center - East Campus
Ph: 435-688-4167
  Salt Lake City
 LDS Hospital
 R. Jeffrey Lee, MD
Ph: 801-408-1146
 Utah Cancer Specialists at UCS Cancer Center
 R. Jeffrey Lee, MD
Ph: 801-408-1146
Vermont
  Saint Johnsbury
 Norris Cotton Cancer Center - North
 Alan Hartford, MD, PhD
Ph: 802-473-4100