Cetuximab, Cisplatin, Fluorouracil, and Radiation Therapy in Treating Patients With Anal Cancer



Status:Active, not recruiting
Conditions:Colorectal Cancer, Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/13/2019
Start Date:January 2007
End Date:May 2022

Use our guide to learn which trials are right for you!

Phase II Trial of Cetuximab Plus Cisplatin, 5- Fluorouracil and Radiation in Immunocompetent Patients With Anal Carcinoma

RATIONALE: Monoclonal antibodies, such as cetuximab, can block tumor growth in different
ways. Some find tumor cells and kill them or carry tumor-killing substances to them. Others
interfere with the ability of tumor cells to grow and spread. Drugs used in chemotherapy,
such as cisplatin and fluorouracil, 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. Cetuximab may help cisplatin and fluorouracil work
better by making tumor cells more sensitive to the drugs. It may also make tumor cells more
sensitive to radiation therapy. Giving cetuximab together with chemotherapy and radiation
therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving cetuximab together with cisplatin,
fluorouracil, and radiation therapy works in treating immunocompetent patients with stage I
(closed to accrual as of 11/3/2008), stage II, (some stage II closed to accrual as of
11/3/2008) or stage III anal cancer.

OBJECTIVES:

Primary Objective:

- Determine whether the addition of cetuximab to combined modality therapy (CMT)
comprising cisplatin, fluorouracil, and radiotherapy reduces the local failure rate by ≥
50% at 3 years (compared with historical data) in immunocompetent patients with stage
I-III invasive anal carcinoma.

Secondary Objectives:

- Determine objective response rate (complete and partial), progression-free survival,
colostomy-free survival, and overall survival.

- Determine the overall toxicity of concurrent cisplatin, fluorouracil, and radiation
therapy combined with cetuximab.

Exploratory Objectives:

- Evaluate the effect of cetuximab and CMT on anogenital herpes papilloma virus (HPV)
infection and anal cytology.

- Evaluate whether moderate to strong expression of epidermal growth factor receptor,
Phosphatidylinositol-4,5-bisphosphate 3-kinase (PI3K), and P-Akt (as determined by
immunohistochemistry) is associated with an increased risk of local failure.

OUTLINE: This is a multicenter study with two sequential arms. Arm I was closed to accrual as
of 11/3/2008, and arm II opened to accrual on 8/18/2009. Patients are assigned to 1 of the 2
treatment arms.

- Arm I (closed to accrual as of 11/3/2008): Patients receive cisplatin intravenously (IV)
over 60 minutes on days 1, 29, 57, and 85 and fluorouracil IV continuously over 96 hours
on days 1-4, 29-32, 57-60, and 85-88. Patients also receive cetuximab IV over 120
minutes on day 50 and then IV over 60 minutes on days 57, 64, 71, 78, 85, 92, and 99 and
undergo radiotherapy once daily 5 days a week for 5 weeks, beginning on day 57.

- Arm II (open to accrual on 8/18/2009): Patients receive cetuximab IV over 120 minutes on
day 1 and then IV over 60 minutes on days 8, 15, 22, 29, 36, 43, and 50. Patients also
receive cisplatin IV over 60 minutes on days 8 and 36, fluorouracil IV continuously over
96 hours on days 8-11 and 36-39, and undergo radiotherapy once daily 5 days a week for 5
weeks beginning on day 8.

After completion of study treatment, patients are followed periodically for up to 10 years.

PROJECTED ACCRUAL: A total of 62 patients will be accrued for this study.

INCLUSION CRITERIA:

- Histologically confirmed anal canal or perianal (anal margin) squamous cell carcinoma

- Stage I-IIIB (closed to accrual as of 11/3/2008)

- Stage II (T3, N0 only), IIIA, or IIIB

- Tumors of nonkeratinizing histology, such as basaloid, transitional cell, or
cloacogenic histology, allowed

- No well-differentiated stage I anal margin cancer

- Eastern Cooperative Oncology Group (ECOG) performance status 0-2

- Hemoglobin ≥ 10 g/dL

- Platelet count ≥ 100,000/mm^3

- Absolute neutrophil count > 1,500/mm^3

- Creatinine ≤ 1.5 times upper limit of normal (ULN) OR creatinine clearance > 60 mL/min

- Bilirubin ≤ 2 times ULN

- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) < 3 times ULN

- Negative pregnancy test

- Fertile patients must use effective contraception during and for ≥ 3 months after
completion of study treatment

- No other malignancies except nonmelanomatous skin cancer

- Prior malignancies must be in remission for ≥ 5 years

- Patients with a known risk factor for human immunodeficiency virus (HIV) infection
must undergo HIV testing within 90 days before study entry AND must be HIV negative by
antibody detection, culture, or quantitative assay of plasma HIV ribonucleic acid
(RNA)

EXCLUSION CRITERIA:

- Presence of the following conditions within the past 6 months:

- Active infection

- Uncontrolled diabetes

- New York Heart Association class II-IV congestive heart failure

- Cerebrovascular accident

- Transient ischemic attack

- Uncontrolled hypertension

- Unstable angina

- Myocardial infarction

- History of rheumatic disorders, irritable bowel syndrome, or inflammatory bowel
disease

- Known HIV positivity

- Known risk factors for HIV infection

- Prior radiotherapy or chemotherapy for this malignancy

- Prior pelvic radiotherapy

- Prior potentially curative surgery (i.e., abdominal or peritoneal resection) for anal
cancer

- Pregnant or nursing
We found this trial at
125
sites
100 Provena Way
Kankakee, Illinois 60914
815.937.8780
Provena St. Mary's Regional Cancer Center - Kankakee For over 20 years, Presence St. Mary's...
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1300 Morris Park Avenue
Bronx, New York 10461
718.430.2302
Albert Einstein Cancer Center at Albert Einstein College of Medicine The Albert Einstein Cancer Center...
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1300 Jefferson Park Avenue
Charlottesville, Virginia 22908
434-243-6784
University of Virginia Cancer Center We are fortunate in having state of the art clinical...
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675 N Saint Clair St # 21-100
Chicago, Illinois 60611
(312) 695-1156
Robert H. Lurie Comprehensive Cancer Center at Northwestern University The cancer center was first established...
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Chicago, IL
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3535 Olentangy River Road
Columbus, Ohio 43214
(614) 566-5000
Riverside Methodist Hospital Cancer Care Serving central Ohio since 1892, Riverside Methodist is consistently ranked...
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200 North Park Street
Kalamazoo, Michigan 49007
(269) 382-2500
West Michigan Cancer Center In 1994, Borgess Health Alliance and Bronson Healthcare Group opened the...
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524 South Park Street
Kalamazoo, Michigan 49007
(269) 341-7654
Bronson Methodist Hospital Our healthcare system serves patients and families throughout southwest Michigan and northern...
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825 N Emporia Ave
Wichita, Kansas 67214
(316) 261-3200
Via Christi Cancer Center at Via Christi Regional Medical Center Via Christi Health's rich history...
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777 Kimole Ln
Adrian, Michigan 49221
517-265-0900
Hickman Cancer Center at Bixby Medical Center At ProMedica Bixby Hospital, we
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6701 North Charles Street
Baltimore, Maryland 21204
443-849-3051
Greater Baltimore Medical Center Cancer Center The Sandra & Malcolm Berman Cancer Institute's comprehensive, multidisciplinary...
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4950 Essen Ln
Baton Rouge, Louisiana 70809
(225) 767-0847
Mary Bird Perkins Cancer Center - Baton Rouge Mary Bird Perkins Cancer Center (MBPCC) and...
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960 W. Wooster
Bowling Green, Ohio 43402
419-352-9498
Wood County Oncology Center The Cancer Care Center at Wood County Hospital opened March 2014,...
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201 E Nicollet Blvd
Burnsville, Minnesota 55337
(952) 892-2000
Fairview Ridges Hospital Fairview Ridges Hospital is a 150-bed, Level III Trauma Care facility, offering...
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701 10th St SE
Cedar Rapids, Iowa 52403
(319) 365-4673
Mercy Regional Cancer Center at Mercy Medical Center Hall-Perrine Cancer Center is a part of...
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525 10th St SE
Cedar Rapids, Iowa 52403
(319) 363-8303
Cedar Rapids Oncology Associates Oncology Associates at Mercy Medical Center in Cedar Rapids (also known...
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505 S Plummer Ave
Chanute, Kansas 66720
(620) 431-7580
Cancer Center of Kansas, PA - Chanute Dr. H.E. Hynes founded Cancer Center of Kansas,...
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676 N St Clair St #2140
Chicago, Illinois 60611
(312) 664-5400
Hematology and Oncology Associates Northwestern Medical Faculty Foundation (the Foundation) is a premier, multi-specialty physician...
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272 Hospital Rd
Chillicothe, Ohio 45601
740-779-7500
Adena Regional Medical Center Since 1895, Adena Health System has remained focused on its commitment...
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12961 27th Ave
Chippewa Falls, Wisconsin 54729
715-738-3700
Marshfield Clinic - Chippewa Center The 15,000 square foot Lake Hallie Center provides urgent care...
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111 S Grant Avenue
Columbus, Ohio 43215
(614) 566-4321
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Columbus, Ohio 43228
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1335 Dublin Road, Suite 124A
Columbus, Ohio 43215
(614) 488-2118
CCOP - Columbus As one of the original 20 CCOPs, the Columbus Community Clinical Oncology...
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793 West State Street
Columbus, Ohio 43222
614-234-5000
Mount Carmel Health - West Hospital Located near downtown Columbus, Mount Carmel West is the...
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11850 Blackfoot St. NW Suite 130
Coon Rapids, Minnesota 55433
763-236-0808
Mercy and Unity Cancer Center at Mercy Hospital The Virginia Piper Cancer Institute - Mercy...
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2300 N. Edward Street
Decatur, Illinois 62526
217-876-8121
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561 W. Central Avenue
Delaware, Ohio 43015
(740) 615-1000
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2020 Central Ave
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(620) 227-2488
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6401 France Ave S
Edina, Minnesota 55435
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700 West Central
El Dorado, Kansas 67042
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41201 Schadden Rd
Elyria, Ohio 44035
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Community Cancer Center When you have cancer, you might think first of treatments
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6282 Linton Blvd
Elyria, Ohio 44035
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1024 S Lemay Ave
Fort Collins, Colorado 80524
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2315 E Harmony Rd #110
Fort Collins, Colorado 80528
(970) 212-7600
Front Range Cancer Specialists At Front Range Cancer Specialists, we are dedicated to providing quality...
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Fort Scott, Kansas 66701
(620) 223-8589
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Fredericksburg, Virginia 22401
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550 Osborne Road
Fridley, Minnesota 55432
763-236-5000
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Highland Park, Illinois 60035
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1095 Minnesota 15
Hutchinson, Minnesota 55350
(320) 234-5000
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800 W. Laurel
Independence, Kansas 67301
620-331-4099
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Indianapolis, Indiana 46202
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535 Barnhill Dr
Indianapolis, Indiana 46202
(888) 600-4822
Indiana University Melvin and Bren Simon Cancer Center At the IU Simon Cancer Center, more...
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250 Doctors Ct
Johnson Creek, Wisconsin 53038
(920) 699-3500
UW Cancer Center Johnson Creek UW Cancer Center Johnson Creek is a collaboration between Fort...
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1521 Gull Rd
Kalamazoo, Michigan 49048
269) 226-7000
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750 Avenue D West
Kingman, Kansas 67068
(620) 532-3147
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401 N Ewing St
Lancaster, Ohio 43130
(740) 687-8000
Fairfield Medical Center We are people you know offering care you trust. Serving more than...
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325 Maine Street
Lawrence, Kansas 66044
(785) 505-5000
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315 W. 15th St.
Liberal, Kansas 67905
(620) 629-6727
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1800 Hollister Drive, Suite 112
Libertyville, Illinois 60048
847-367-6781
North Shore Oncology and Hematology Associates, Limited - Libertyville Welcome to North Shore Oncology and...
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1001 Bellefontaine Ave
Lima, Ohio 45804
(419) 228-3335
Lima Memorial Hospital We also offer an extended network of primary care, pediatric and specialist...
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4600 Valley Rd # 336
Lincoln, Nebraska 68510
(402) 483-2827
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1580 Beam Ave
Maplewood, Minnesota 55109
(651) 779-7978
Minnesota Oncology - Maplewood At Minnesota Oncology, we join together with you in a firm...
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1575 Beam Avenue
Maplewood, Minnesota 55109
651-232-7970
HealthEast Cancer Care at St. John's Hospital From the moment patients and visitors walk into...
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401 Matthew St
Marietta, Ohio 45750
(740) 376-5000
Strecker Cancer Center at Marietta Memorial Hospital The Memorial Health System's Strecker Cancer Center combines...
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1000 N Oak Ave
Marshfield, Wisconsin 54449
(715) 387-5511
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5805 Monclova Rd
Maumee, Ohio 43537
(419) 891-5600
Northwest Ohio Oncology Center The Northwest Ohio Oncology Center, located on the campus of ProMedica...
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800 E 28th St
Minneapolis, Minnesota 55407
612-863-4000
Virginia Piper Cancer Institute at Abbott - Northwestern Hospital As the largest hospital in the...
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701 Park Ave
Minneapolis, Minnesota 55415
(612) 873-3000
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Minocqua, Wisconsin 54548
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Monroe, Michigan 48162
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800 Stewart Rd
Monroe, Michigan 48162
(734) 242-7902
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100 Madison Avenue
Morristown, New Jersey 07960
973-971-6100
Carol G. Simon Cancer Center at Morristown Memorial Hospital Located in northern New Jersey, we...
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1330 Coshocton Ave
Mount Vernon, Ohio 43050
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New Orleans, Louisiana 70112
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533 Bolivar Street, Room 420
New Orleans, Louisiana 70112
(504) 568-3435
MBCCOP - LSU Health Sciences Center Established in 1990, the Stanley S. Scott Cancer Center...
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160 E 34th St
New York, New York 10016
(212) 731-5001
NYU Cancer Institute at New York University Medical Center The Perlmutter Cancer Center takes a...
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1320 West Main Street
Newark, Ohio 43055
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720 Medical Center Drive
Newton, Kansas 67114
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8915 W Golf Rd
Niles, Illinois 60714
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6901 N 72nd St
Omaha, Nebraska 68122
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7500 Mercy Rd
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601 N 30th St
Omaha, Nebraska 68131
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2600 Navarre Ave
Oregon, Ohio 43616
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1902 S. US Hwy 59
Parsons, Kansas 67357
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Philadelphia, Pennsylvania 19111
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1121 Kinneys Ln
Portsmouth, Ohio 45662
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124 Commodore, Ste. A
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2251 North Shore Drive
Rhinelander, Wisconsin 54501
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Rice Lake, Wisconsin 54868
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3435 W Broadway Ave
Robbinsdale, Minnesota 55422
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3535 N Bell School Rd
Rockford, Illinois 61114
(779) 696-9400
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Saint Louis Park, Minnesota 55416
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3931 Louisiana Ave S
Saint Louis Park, Minnesota 55426
(952) 993-3248
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Saint Paul, Minnesota 55101
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333 Smith Ave
Saint Paul, Minnesota 55102
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600 S Santa Fe Ave
Salina, Kansas 67401
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1455 St. Francis Ave.
Shakopee, Minnesota 55379
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230 Nebraska St.
Sioux City, Iowa 51101
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801 5th St
Sioux City, Iowa 51104
(712) 279-2010
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2720 Stone Park Blvd
Sioux City, Iowa 51104
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100 Medical Center Drive
Springfield, Ohio 45504
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630 Medical Dr
Stillwater, Minnesota 84010
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