Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

Trial Description

Summary

This phase I/II trial is studying the side effects of giving paclitaxel together with radiation therapy with or without trastuzumab and to see how well it works to kill any remaining tumor cells in patients who have undergone surgery for bladder cancer. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Radiation therapy uses high-energy x-rays to kill tumor cells. Paclitaxel may also make tumor cells more sensitive to radiation therapy. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving paclitaxel together with radiation therapy and trastuzumab may kill more tumor cells. Giving these treatments after surgery may kill any remaining tumor cells

Further Study Information

PRIMARY OBJECTIVE:

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.

SECONDARY OBJECTIVES:

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.

Eligibility Criteria

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 mapping

• 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 AIDS

• No other severe active comorbidity

• No prior systemic chemotherapy with anthracyclines or taxanes

• No prior systemic chemotherapy for TCC

• No prior pelvic radiotherapy

Trial Contact Information

Trial Lead Organizations/Sponsors

National Cancer Institute

M. Dror Michaelson

Principal Investigator

U.S.A.
Alaska
	Anchorage
	Providence Cancer Center
		John B Halligan	Ph: 907-261-3109
California
	Auburn
	Auburn Radiation Oncology
		Christopher Jones	Ph: 916-646-8300
	Cameron Park
	Radiation Oncology Centers - Cameron Park
		Christopher Jones	Ph: 916-646-8300
	Carmichael
	Mercy Cancer Center at Mercy San Juan Medical Center
		Christopher Jones	Ph: 916-646-8300
	Roseville
	Radiation Oncology Center - Roseville
		Christopher Jones	Ph: 916-646-8300
	Sacramento
	Mercy General Hospital
		Christopher Jones	Ph: 916-646-8300
	Radiological Associates of Sacramento Medical Group, Incorporated
		Christopher Jones	Ph: 916-646-8300
	Vacaville
	Solano Radiation Oncology Center
		Christopher Jones	Ph: 916-646-8300
Colorado
	Colorado Springs
	Penrose Cancer Center at Penrose Hospital
		Anuj Peddada	Ph: 888-785-6789
Delaware
	Newark
	Helen F. Graham Cancer Center at Christiana Hospital
		Adam Raben	Ph: 302-733-6227
Florida
	Fort Lauderdale
	Michael and Dianne Bienes Comprehensive Cancer Center at Holy Cross Hospital
		Leonard M Toonkel	Ph: 305-674-2625
			Email: info@msccop.com
	Jupiter
	Ella Milbank Foshay Cancer Center at Jupiter Medical Center
		Leonard M Toonkel	Ph: 305-674-2625
			Email: info@msccop.com
	Miami Beach
	CCOP - Mount Sinai Medical Center
		Leonard M Toonkel	Ph: 305-674-2625
			Email: info@msccop.com
Illinois
	Peoria
	CCOP - Illinois Oncology Research Association
		John W. Kugler	Ph: 800-793-2262
	Illinois CancerCare - Peoria
		John W. Kugler	Ph: 800-793-2262
Indiana
	Fort Wayne
	Parkview Regional Cancer Center at Parkview Health
		Brian K Chang	Ph: 260-373-8888
			Email: parkviewresearch@parkview.com
	Radiation Oncology Associates Southwest
		Brian K Chang	Ph: 260-373-8888
			Email: parkviewresearch@parkview.com
Iowa
	Ames
	McFarland Clinic, PC
		Joseph James Merchant	Ph: 515-239-2621
	Sioux City
	Mercy Medical Center - Sioux City
		Donald Bruce Wender	Ph: 712-252-0088
	Siouxland Hematology-Oncology Associates, LLP
		Donald Bruce Wender	Ph: 712-252-0088
	St. Luke's Regional Medical Center
		Donald Bruce Wender	Ph: 712-252-0088
Kansas
	Dodge City
	Cancer Center of Kansas, PA - Dodge City
		Shaker R. Dakhil	Ph: 316-262-4467
	El Dorado
	Cancer Center of Kansas, PA - El Dorado
		Shaker R. Dakhil	Ph: 316-262-4467
	Kansas City
	Kansas Masonic Cancer Research Institute at the University of Kansas Medical Center
		Parvesh Kumar	Ph: 913-588-4709
	Lawrence
	Lawrence Memorial Hospital
		Shaker R. Dakhil	Ph: 316-262-4467
	Salina
	Cancer Center of Kansas, PA - Salina
		Shaker R. Dakhil	Ph: 316-262-4467
	Wellington
	Cancer Center of Kansas, PA - Wellington
		Shaker R. Dakhil	Ph: 316-262-4467
	Wichita
	Associates in Women's Health, PA - North Hillside
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Medical Arts Tower
		Shaker R. Dakhil	Ph: 316-262-4467
	Cancer Center of Kansas, PA - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	CCOP - Wichita
		Shaker R. Dakhil	Ph: 316-262-4467
	Via Christi Cancer Center at Via Christi Regional Medical Center
		Shaker R. Dakhil	Ph: 316-262-4467
	Wesley Medical Center
		Shaker R. Dakhil	Ph: 316-262-4467
	Winfield
	Cancer Center of Kansas, PA - Winfield
		Shaker R. Dakhil	Ph: 316-262-4467
Massachusetts
	Boston
	Massachusetts General Hospital
		M. Dror Michaelson	Ph: 877-726-5130
Michigan
	Kalamazoo
	Borgess Medical Center
		Raymond Sterling Lord	Ph: 269-373-7458
	Bronson Methodist Hospital
		Raymond Sterling Lord	Ph: 269-373-7458
	West Michigan Cancer Center
		Raymond Sterling Lord	Ph: 269-373-7458
Montana
	Great Falls
	Benefis Sletten Cancer Institute
		Grant William Harrer	Ph: 406-731-8217
Nevada
	Las Vegas
	CCOP - Nevada Cancer Research Foundation
		John Allan Ellerton	Ph: 702-731-8274
New Hampshire
	Keene
	Kingsbury Center for Cancer Care at Cheshire Medical Center
		Alan C. Hartford	Ph: 800-639-6918
			Email: cancer.research.nurse@dartmouth.edu
	Lebanon
	Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
		Alan C. Hartford	Ph: 800-639-6918
			Email: cancer.research.nurse@dartmouth.edu
North Dakota
	Bismarck
	Medcenter One Hospital Cancer Care Center
		John T Reynolds	Ph: 701-323-5760
			Email: tfischer@mohs.org
	Mid Dakota Clinic, PC
		John T Reynolds	Ph: 701-323-5760
			Email: tfischer@mohs.org
	St. Alexius Medical Center Cancer Center
		John T Reynolds	Ph: 701-323-5760
			Email: tfischer@mohs.org
Ohio
	Canton
	Mercy Cancer Center at Mercy Medical Center
		Mitchell Haut	Ph: 888-293-4673
	Cleveland
	MetroHealth Cancer Care Center at MetroHealth Medical Center
		Bruce J. Averbook	Ph: 216-778-8526
			Email: kbauchens@metrohealth.org
Pennsylvania
	Philadelphia
	Kimmel Cancer Center at Thomas Jefferson University - Philadelphia
		Adam P. Dicker	Ph: 215-955-6084
South Carolina
	Charleston
	Hollings Cancer Center at Medical University of South Carolina
		David T Marshall	Ph: 843-792-9321
Utah
	Cedar City
	Sandra L. Maxwell Cancer Center
		R. Jeffrey Lee	Ph: 801-507-3950
	Logan
	Logan Regional Hospital
		R. Jeffrey Lee	Ph: 801-507-3950
	Murray
	Jon and Karen Huntsman Cancer Center at Intermountain Medical Center
		R. Jeffrey Lee	Ph: 801-507-3950
	Ogden
	Val and Ann Browning Cancer Center at McKay-Dee Hospital Center
		R. Jeffrey Lee	Ph: 801-507-3950
	Provo
	Utah Valley Regional Medical Center - Provo
		R. Jeffrey Lee	Ph: 801-507-3950
	Saint George
	Dixie Regional Medical Center - East Campus
		R. Jeffrey Lee	Ph: 801-507-3950
	Salt Lake City
	LDS Hospital
		R. Jeffrey Lee	Ph: 801-507-3950
	Utah Cancer Specialists at UCS Cancer Center
		R. Jeffrey Lee	Ph: 801-507-3950
Vermont
	Saint Johnsbury
	Norris Cotton Cancer Center - North
		Alan C. Hartford	Ph: 800-639-6918
			Email: cancer.research.nurse@dartmouth.edu
Virginia
	Danville
	Danville Regional Medical Center
		Kiran Patel	Ph: 434-799-3753
Washington
	Federal Way
	St. Francis Hospital
		Huong T. Pham	Ph: 425-899-3181
	Puyallup
	Good Samaritan Cancer Center
		Yoshio Inoue	Ph: 253-403-2394
	Tacoma
	CCOP - Northwest
		Yoshio Inoue	Ph: 253-403-2394
	Franciscan Cancer Center at St. Joseph Medical Center
		Yoshio Inoue	Ph: 253-403-2394
	MultiCare Regional Cancer Center at Tacoma General Hospital
		Yoshio Inoue	Ph: 253-403-2394
Canada
Alberta
	Edmonton
	Cross Cancer Institute at University of Alberta
		Samir I Patel	Ph: 780-432-8500
Quebec
	Montreal
	McGill Cancer Centre at McGill University
		Luis Souhami	Ph: 514-934-1934ext42953
			Email: evelyn.ortega@muhc.mcgill.ca

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00238420
Information obtained from ClinicalTrials.gov on March 19, 2013

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