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

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 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

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