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

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

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

Outcomes

Safety during weekly treatment

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 up 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
Huong Pham, MD, Protocol co-chair		Ph: 206-223-6801 Email: huong.pham@vmmc.org
Douglas Dahl, MD, Protocol co-chair		Ph: 617-726-0874; 877-726-5130 Email: ddahl@partners.org

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
	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:  302-623-4450
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Clinical Trials Office - Michael and Dianne Bienes Comprehensive Cancer Center	Ph:  954-776-3239
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Clinical Trials Office - Ella Milbank Foshay Cancer Center	Ph:  561-745-5768
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Leonard Toonkel	Ph:  305-674-2625
	Orlando
	M.D. Anderson Cancer Center at Orlando
		Akash Nanda	Ph:  407-648-3800 800-648-3818
Illinois
	Normal
	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
	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
Indiana
	Fort Wayne
	Parkview Regional Cancer Center at Parkview Health
		Brian Chang	Ph:  260-373-7850
	Radiation Oncology Associates Southwest
		Brian Chang	Ph:  260-436-4116
Iowa
	Ames
	McFarland Clinic, PC
		Clinical Trials Office - McFarland Clinic, PC	Ph:  515-239-2621
	Des Moines
	CCOP - Iowa Oncology Research Association
		Robert Behrens	Ph:  515-244-7586 888-244-6061
	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
		Robert Behrens	Ph:  515-282-2921
	Medical Oncology and Hematology Associates at Mercy Cancer Center
		Robert Behrens	Ph:  515-643-8740
	Mercy Cancer Center at Mercy Medical Center - Des Moines
		Robert Behrens	Ph:  515-643-8206 888-221-4849
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Wender, MD, PhD	Ph:  712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Wender, MD, PhD	Ph:  712-252-0088
	St. Luke's Regional Medical Center
		Donald Wender, MD, PhD	Ph:  712-252-0088
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
	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
	Lawrence
	Lawrence Memorial Hospital
		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
	Cancer Center of Kansas, PA - Wichita
		Shaker Dakhil, MD, FACP	Ph:  316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		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
Mississippi
	Pascagoula
	Regional Cancer Center at Singing River Hospital
		James Clarkson, MD	Ph:  228-374-6296
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
	Bozeman
	Bozeman Deaconess Cancer Center
		Benjamin Marchello, MD	Ph:  406-238-6290
	Great Falls
	Big Sky Oncology
		Clinical Trial Office - Big Sky Oncology	Ph:  406-731-8217
	Great Falls Clinic - Main Facility
		Benjamin Marchello, MD	Ph:  406-238-6290
	Sletten Cancer Institute at Benefis Healthcare
		Grant Harrer, MD, FACP, CCTI	Ph:  406-731-8100
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
	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
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
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
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce Averbook, MD, FACS	Ph:  216-778-4795
	Salem
	Cancer Care Center, Incorporated
		William Demas, MD	Ph:  330-375-3557
	Wooster
	Cancer Treatment Center
		Clinical Trials Office - Cancer Treatment Center	Ph:  330-375-4221
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
	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
Virginia
	Danville
	Danville Regional Medical Center
		Clinical Trials Office - Danville Regional Medical Center	Ph:  434-799-3753
Washington
	Federal Way
	St. Francis Hospital
		Huong Pham, MD	Ph:  206-223-6801
	Puyallup
	Good Samaritan Cancer Center
		Yoshio Inoue	Ph:  253-697-4000
	Tacoma
	CCOP - Northwest
		Yoshio Inoue	Ph:  253-403-1461
	Franciscan Cancer Center at St. Joseph Medical Center
		Clinical Trials Office - Franciscan Cancer Center	Ph:  253-426-6914
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Clinical Trials Office - MultiCare Regional Cancer Center	Ph:  253-403-3229
Wyoming
	Sheridan
	Welch Cancer Center at Sheridan Memorial Hospital
		Benjamin Marchello, MD	Ph:  406-238-6290
Canada
Alberta
	Edmonton
	Cross Cancer Institute at University of Alberta
		Samir Patel	Ph:  780-432-8771
Quebec
	Montreal
	McGill Cancer Centre at McGill University
		Luis Souhami	Ph:  514-398-1444

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		2012-05-24
NCI Grant/Contract Number		CA21661

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