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


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Anal Cancer

Thank you

Trial Information

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


OBJECTIVES:

Primary

- 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-IIIB invasive anal carcinoma.

Secondary

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

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

- 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,
PI3K, and P-Akt (as determined by immunohistochemistry) is associated with an increased
risk of local failure.

OUTLINE: This is a multicenter study. Patients are assigned to 1 of 2 treatment arms.

- Arm I (closed to accrual as of 11/3/2008): Patients receive cisplatin 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.
Treatment continues in the absence of disease progression or unacceptable toxicity.

- Arm II: 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. Treatment continues in the absence of disease progression or unacceptable
toxicity.

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


DISEASE CHARACTERISTICS:

- 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

PATIENT CHARACTERISTICS:

- 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

- AST and ALT < 3 times ULN

- Not pregnant or nursing

- 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

- None 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

- No history of rheumatic disorders, irritable bowel syndrome, or inflammatory bowel
disease

- No known HIV positivity

- No known risk factors for HIV infection

- Patients with a known risk factor for 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 RNA

PRIOR CONCURRENT THERAPY:

- No prior radiotherapy or chemotherapy for this malignancy

- No prior pelvic radiotherapy

- No prior potentially curative surgery (i.e., abdominal or peritoneal resection) for
anal cancer

- No concurrent intensity-modulated radiotherapy

Type of Study:

Interventional

Study Design:

Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Local failure rate at 3 years

Safety Issue:

No

Principal Investigator

Madhur K. Garg, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Montefiore Medical Center

Authority:

Unspecified

Study ID:

CDR0000470269

NCT ID:

NCT00316888

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Anal Cancer
  • squamous cell carcinoma of the anus
  • stage I anal cancer
  • stage II anal cancer
  • stage IIIA anal cancer
  • stage IIIB anal cancer
  • basaloid carcinoma of the anus
  • cloacogenic carcinoma of the anus
  • Anus Neoplasms

Name

Location

CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Carle Cancer CenterUrbana, Illinois  61801
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Cedar Rapids Oncology AssociatesCedar Rapids, Iowa  52403
Mercy Medical Center - Sioux CitySioux City, Iowa  51104
Siouxland Hematology-Oncology Associates, LLPSioux City, Iowa  51101
St. Luke's Regional Medical CenterSioux City, Iowa  51104
Bronson Methodist HospitalKalamazoo, Michigan  49007
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
Borgess Medical CenterKalamazooaa, Michigan  49001
Fairview Ridges HospitalBurnsville, Minnesota  55337
Mercy and Unity Cancer Center at Mercy HospitalCoon Rapids, Minnesota  55433
Fairview Southdale HospitalEdina, Minnesota  55435
Mercy and Unity Cancer Center at Unity HospitalFridley, Minnesota  55432
Hutchinson Area Health CareHutchinson, Minnesota  55350
HealthEast Cancer Care at St. John's HospitalMaplewood, Minnesota  55109
Hennepin County Medical Center - MinneapolisMinneapolis, Minnesota  55415
Virginia Piper Cancer Institute at Abbott - Northwestern HospitalMinneapolis, Minnesota  55407
St. Francis Cancer Center at St. Francis Medical CenterShakopee, Minnesota  55379
Park Nicollet Cancer CenterSt. Louis Park, Minnesota  55416
Regions Hospital Cancer Care CenterSt. Paul, Minnesota  55101
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
University of Wisconsin Paul P. Carbone Comprehensive Cancer CenterMadison, Wisconsin  53792-6164
Marshfield Clinic - Marshfield CenterMarshfield, Wisconsin  54449
Marshfield Clinic - Indianhead CenterRice Lake, Wisconsin  54868
CCOP - ColumbusColumbus, Ohio  43206
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
St. Vincent Mercy Medical CenterToledo, Ohio  43608
Overlook HospitalSummit, New Jersey  07902-0220
Carol G. Simon Cancer Center at Morristown Memorial HospitalMorristown, New Jersey  07962
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Via Christi Cancer Center at Via Christi Regional Medical CenterWichita, Kansas  67214
Albert Einstein Cancer Center at Albert Einstein College of MedicineBronx, New York  10461
NYU Cancer Institute at New York University Medical CenterNew York, New York  10016
Medical University of Ohio Cancer CenterToledo, Ohio  43614
Toledo HospitalToledo, Ohio  43606
Adena Regional Medical CenterChillicothe, Ohio  54601
Doctors Hospital at Ohio HealthColumbus, Ohio  43228
Riverside Methodist Hospital Cancer CareColumbus, Ohio  43214
Grady Memorial HospitalDelaware, Ohio  43015
Fairfield Medical CenterLancaster, Ohio  43130
Strecker Cancer Center at Marietta Memorial HospitalMarietta, Ohio  45750
Licking Memorial Cancer Care Program at Licking Memorial HospitalNewark, Ohio  43055
Community Hospital of Springfield and Clark CountySpringfield, Ohio  45505
Genesis - Good Samaritan HospitalZanesville, Ohio  43701
Swedish-American Regional Cancer CenterRockford, Illinois  61104-2315
Indiana University Melvin and Bren Simon Cancer CenterIndianapolis, Indiana  46202-5289
University of Virginia Cancer CenterCharlottesville, Virginia  22908
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Mount Carmel Health - West HospitalColumbus, Ohio  43222
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Front Range Cancer SpecialistsFort Collins, Colorado  80528
Hematology Oncology Associates - SkokieSkokie, Illinois  60076
Joan Karnell Cancer Center at Pennsylvania HospitalPhiladelphia, Pennsylvania  19107
Poudre Valley HospitalFort Collins, Colorado  80524
Hematology and Oncology AssociatesChicago, Illinois  60611
North Shore Oncology and Hematology Associates, Limited - LibertyvilleLibertyville, Illinois  60048
Mercy Regional Cancer Center at Mercy Medical CenterCedar Rapids, Iowa  52403
Cancer Center of Kansas, PA - Dodge CityDodge City, Kansas  67801
Mary Bird Perkins Cancer Center - Baton RougeBaton Rouge, Louisiana  70809
Medical Center of Louisiana - New OrleansNew Orleans, Louisiana  70112
Hickman Cancer Center at Bixby Medical CenterAdrian, Michigan  49221
Community Cancer Center of MonroeMonroe, Michigan  48162
Immanuel Medical CenterOmaha, Nebraska  68122
Creighton University Medical CenterOmaha, Nebraska  68131-2197
Wood County Oncology CenterBowling Green, Ohio  43402
Lima Memorial HospitalLima, Ohio  45804
Northwest Ohio Oncology CenterMaumee, Ohio  43537
Toledo Clinic - OregonOregon, Ohio  43616
St. Charles Mercy HospitalOregon, Ohio  43616
Mercy Hospital of TiffinTiffin, Ohio  44883
Toledo Clinic, Incorporated - Main ClinicToledo, Ohio  43623
Fulton County Health CenterWauseon, Ohio  43567
Cancer Resource Center - LincolnLincoln, Nebraska  68510
Stanford Cancer CenterStanford, California  94305-5824
Kellogg Cancer Care CenterHighland Park, Illinois  60035
Cancer Care and Hematology Specialists of Chicagoland - NilesNiles, Illinois  60714
William N. Wishard Memorial HospitalIndianapolis, Indiana  46202
Cancer Center of Kansas, PA - ChanuteChanute, Kansas  66720
Cancer Center of Kansas, PA - El DoradoEl Dorado, Kansas  67042
Cancer Center of Kansas - Fort ScottFort Scott, Kansas  66701
Cancer Center of Kansas-IndependenceIndependence, Kansas  67301
Cancer Center of Kansas, PA - KingmanKingman, Kansas  67068
Lawrence Memorial HospitalLawrence, Kansas  66044
Cancer Center of Kansas, PA - LiberalLiberal, Kansas  67905
Cancer Center of Kansas, PA - NewtonNewton, Kansas  67114
Cancer Center of Kansas, PA - ParsonsParsons, Kansas  67357
Cancer Center of Kansas, PA - PrattPratt, Kansas  67124
Cancer Center of Kansas, PA - SalinaSalina, Kansas  67401
Cancer Center of Kansas, PA - WellingtonWellington, Kansas  67152
Cancer Center of Kansas, PA - WichitaWichita, Kansas  67214
Associates in Womens Health, PA - North ReviewWichita, Kansas  67208
Cancer Center of Kansas, PA - Medical Arts TowerWichita, Kansas  67208
Cancer Center of Kansas, PA - WinfieldWinfield, Kansas  67156
Greater Baltimore Medical Center Cancer CenterBaltimore, Maryland  21204
Mercy Memorial Hospital - MonroeMonroe, Michigan  48162
Willmar Cancer Center at Rice Memorial HospitalWillmar, Minnesota  56201
Alegant Health Cancer Center at Bergan Mercy Medical CenterOmaha, Nebraska  68124
Grant Medical Center Cancer CareColumbus, Ohio  43215
Hematology Oncology CenterElyria, Ohio  44035
Community Cancer CenterElyria, Ohio  44035
Knox Community HospitalMount Vernon, Ohio  43050
Flower Hospital Cancer CenterSylvania, Ohio  43560
St. Anne Mercy HospitalToledo, Ohio  43623
Hematology and Oncology Associates of Northeastern PennsylvaniaScranton, Pennsylvania  18510
Fredericksburg Oncology, IncorporatedFredericksburg, Virginia  22401
Marshfield Clinic - Chippewa CenterChippewa Falls, Wisconsin  54729
Marshfield Clinic Cancer Care at Regional Cancer CenterEau Claire, Wisconsin  54701
UW Cancer Center Johnson CreekJohnson Creek, Wisconsin  53038
Marshfield Clinic - Lakeland CenterMinocqua, Wisconsin  54548
Ministry Medical Group at Saint Mary's HospitalRhinelander, Wisconsin  54501
Marshfield Clinic at Saint Michael's HospitalStevens Point, Wisconsin  54481
Marshfield Clinic - Wausau CenterWausau, Wisconsin  54401
Marshfield Clinic - Weston CenterWeston, Wisconsin  54476
Marshfield Clinic - Wisconsin Rapids CenterWisconsin Rapids, Wisconsin  54494
Provena St. Mary's Regional Cancer Center - KankakeeKankakee, Illinois  60901
Minnesota Oncology - MaplewoodMaplewood, Minnesota  55109
Humphrey Cancer Center at North Memorial Outpatient CenterRobbinsdale, Minnesota  55422-2900
Lakeview HospitalStillwater, Minnesota  55082
Minnesota Oncology - WoodburyWoodbury, Minnesota  55125
Lakeside HospitalOmaha, Nebraska  68130
Southern Ohio Medical Center Cancer CenterPortsmouth, Ohio  45662