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Last Modified: 11/5/2009     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

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ITreatmentActive18 and overNCIRTOG-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
    • 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 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 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 1 year, every 4 months for 1 year, 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: 916-646-6600
  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: 916-646-6600
  Carmichael
 Mercy Cancer Center at Mercy San Juan Medical Center
 Christopher Jones, MD
Ph: 916-646-6600
  Roseville
 Radiation Oncology Center - Roseville
 Christopher Jones, MD
Ph: 916-646-6600
  Sacramento
 Mercy General Hospital
 Christopher Jones, MD
Ph: 916-646-6600
 Radiological Associates of Sacramento Medical Group, Incorporated
 Christopher Jones, MD
Ph: 916-646-6600
  Vacaville
 Solano Radiation Oncology Center
 Christopher Jones, MD
Ph: 916-646-6600
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
Florida
  Gainesville
 University of Florida Shands Cancer Center
 Clinical Trials Office - University of Florida Shands Cancer Center
Ph: 888-254-7581
Illinois
  Bloomington
 St. Joseph Medical Center
 John Kugler, MD
Ph: 309-243-3605
  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: 309-243-3605
  Normal
 BroMenn Regional Medical Center
 John Kugler, MD
Ph: 309-243-3605
 Community Cancer Center
 John Kugler, MD
Ph: 309-243-3605
  Pekin
 Cancer Treatment Center at Pekin Hospital
 John Kugler, MD
Ph: 309-243-3605
  Peoria
 CCOP - Illinois Oncology Research Association
 John Kugler, MD
Ph: 309-243-3605
 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: 309-243-3605
 OSF St. Francis Medical Center
 John Kugler, MD
Ph: 309-243-3605
 John Kugler, MD
Ph: 309-243-3605
  Spring Valley
 Valley Cancer Center
 John Kugler, MD
Ph: 309-243-3605
  Springfield
 Regional Cancer Center at Memorial Medical Center
 Clinical Trials Office - Regional Cancer Center at Memorial Medical Center
Ph: 217-788-4233
Indiana
  Fort Wayne
 Parkview Regional Cancer Center at Parkview Health
 Brian Chang
Ph: 260-373-7850
 Radiation Oncology Associates Southwest
 Tony Lee
Ph: 260-373-7850
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: 515-282-2921
 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: 515-282-2921
 Medical Oncology and Hematology Associates at Mercy Cancer Center
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
 Mercy Cancer Center at Mercy Medical Center - Des Moines
 Roscoe Morton, MD, FACP
Ph: 515-282-2921
Kansas
  Dodge City
 Cancer Center of Kansas, PA - Dodge City
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  El Dorado
 Cancer Center of Kansas, PA - El Dorado
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Liberal
 Southwest Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wellington
 Cancer Center of Kansas, PA - Wellington
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Wichita
 Associates in Womens Health, PA - North Review
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 CCOP - Wichita
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Via Christi Cancer Center at Via Christi Regional Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
 Wesley Medical Center
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
  Winfield
 Cancer Center of Kansas, PA - Winfield
 Shaker Dakhil, MD, FACP
Ph: 316-262-4467
Massachusetts
  Boston
 Beth Israel Deaconess Medical Center
 Clinical Trials Office - Beth Israel Deaconess Medical Center
Ph: 617-667-9925
 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
Montana
  Billings
 Billings Clinic - Downtown
 Clinical Trials Office - Billings Clinic - Downtown
Ph: 800-996-2663
 Email: research@billingsclinic.org
 CCOP - Montana Cancer Consortium
 Benjamin Marchello, MD
Ph: 406-238-6290
 Northern Rockies Radiation Oncology Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Bozeman
 Bozeman Deaconess Cancer Center
 Benjamin Marchello, MD
Ph: 406-238-6290
  Great Falls
 Benjamin Marchello, MD
Ph: 406-238-6290
 Great Falls Clinic - Main Facility
 Benjamin Marchello, MD
Ph: 406-238-6290
Nevada
  Las Vegas
 CCOP - Nevada Cancer Research Foundation
 John Ellerton, MD, CM
Ph: 702-384-0013
New Hampshire
  Keene
 Kingsbury Center for Cancer Care at Cheshire Medical Center
 Alan Hartford, MD, PhD
Ph: 603-650-6600
  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
New York
  Poughkeepsie
 Hudson Valley Oncology Associates
 Adam Dicker, MD, PhD
Ph: 215-955-6527
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: 252-559-2200ext.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
 Summa Center for Cancer Care at Akron City Hospital
 Clinical Trials Office - Akron City Hospital
Ph: 330-375-6101
  Barberton
 Barberton Citizens Hospital
 William Demas, MD
Ph: 330-375-3557
  Canton
 Mercy Cancer Center at Mercy Medical Center
 Mitchell Haut, MD
Ph: 330-453-9993
  Cleveland
 Cleveland Clinic Taussig Cancer Center
 Clinical Trials Office - Cleveland Clinic Taussig Cancer Center
Ph: 866-223-8100
 MetroHealth Cancer Care Center at MetroHealth Medical Center
 Bruce Averbook, MD, FACS
Ph: 216-778-4795
Oklahoma
  Oklahoma City
 Oklahoma University Cancer Institute
 Terence Herman
Ph: 405-271-6822
Pennsylvania
  Dunmore
 Northeast Radiation Oncology Center
 Adam Dicker, MD, PhD
Ph: 215-955-6527
  Media
 Riddle Memorial Hospital Cancer Center
 Adam Dicker, MD, PhD
Ph: 215-955-6527
  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
Vermont
  Saint Johnsbury
 Norris Cotton Cancer Center - North
 Alan Hartford, MD, PhD
Ph: 603-650-6600
Wisconsin
  Milwaukee
 Medical College of Wisconsin Cancer Center
 Clinical Trials Office - Medical College of Wisconsin Cancer Center
Ph: 414-805-4380
Wyoming
  Sheridan
 Welch Cancer Center at Sheridan Memorial Hospital
 Benjamin Marchello, MD
Ph: 406-238-6290

Related Information

Featured trial article

Registry Information
Official Title 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
Trial Start Date 2005-07-26
Trial Completion Date 2012-07-15 (estimated)
Registered in ClinicalTrials.gov NCT00238420
Date Submitted to PDQ 2005-07-12
Information Last Verified 2009-11-05
NCI Grant/Contract Number CA21661

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.

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