Know Cancer

or
forgot password

A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Head and Neck Cancer

Thank you

Trial Information

A Phase II Randomized Trial Of Surgery Followed By Chemoradiotherapy Plus Cetuximab For Advanced Squamous Cell Carcinoma Of The Head and Neck


OBJECTIVES:

Primary

- Compare disease-free survival of patients with resected stage III or IV squamous cell
carcinoma or lymphoepithelioma of the head and neck treated with adjuvant cetuximab in
combination with chemoradiotherapy comprising docetaxel vs cisplatin.

Secondary

- Compare the safety and efficacy of these regimens in these patients.

- Compare locoregional control and overall survival rates in patients treated with these
regimens.

- Correlate epidermal growth factor receptor (total and phosphorylated), pMAPK, pAKT,
Stat-3, Ki-67, cyclo-oxygenase-2, and cyclin B1 expression with outcome in patients
treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
Zubrod performance status (0 vs 1), risk category (positive margins vs high risk [i.e., ≥ 2
positive nodes or extracapsular nodal extension]) and use of intensity-modulated
radiotherapy (no vs yes). Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive cetuximab IV over 2 hours on day 1 (week 1). Patients then
receive cetuximab IV over 1 hour and cisplatin IV over 1 hour before radiotherapy on
days 8, 15, 22, 29, 36, and 43 (weeks 2-7). Patients undergo radiotherapy once daily, 5
days a week, beginning on day 8 for a total of 6 weeks (weeks 2-7).

- Arm II: Patients receive cetuximab and undergo radiotherapy as in arm I. Patients also
receive docetaxel IV over 30 minutes before radiotherapy on days 8, 15, 22, 29, 36, and
43 (weeks 2-7).

Treatment in both arms continues in the absence of disease progression or unacceptable
toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 4 years, and
then annually thereafter.

PROJECTED ACCRUAL: A total of 230 patients (115 per treatment arm) will be accrued for this
study within approximately 29 months.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck meeting the
following criteria:

- Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx
(excluding lip, nasopharynx, or sinuses)

- Gross total resection must be completed within 7 weeks of randomization, with
pathology demonstrating one or more of the following risk factors:

- Histologic extracapsular nodal extension

- Histologic involvement of ≥ 2 regional lymph nodes

- Invasive cancer seen on microscopic evaluation of the resection margin,
with no evidence of gross tumor residual. or lymphoepithelioma of the oral
cavity, oropharynx, larynx, or hypopharynx

- Tonsillar cancer patients who undergo transoral excision of all gross tumor
are eligible provided extracapsular nodal extension or involvement of ≥ 2
regional lymph nodes is histologically confirmed

- Stage III or IV disease after gross total resection completed within the past 7
weeks

- No evidence of distant metastases

- No synchronous or concurrent head and neck primary tumors

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Zubrod 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count ≥ 2,000/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin > 8.0 g/dL

Hepatic

- Bilirubin ≤ 1.5 times upper limit of normal (ULN)

- AST or ALT, and alkaline phosphatase meeting 1 of the following parameters:

- Alkaline phosphatase ≤ ULN AND AST or ALT ≤ 5 times ULN

- Alkaline phosphatase ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN

- Alkaline phosphatase ≤ 5 times ULN AND AST or ALT ≤ ULN

Renal

- Creatinine ≤ 1.5 mg/dL

Cardiovascular

- No unstable angina

- No uncontrolled hypertension

- No myocardial infarction within the past 6 months (unless successfully treated with
coronary artery bypass surgery or percutaneous transluminal coronary angioplasty)

- No uncontrolled arrhythmia

- No congestive heart failure

- No more than 2 heart-related hospitalizations within the past year

- No other active cardiac disease

Pulmonary

- No more than 2 hospitalizations for chronic obstructive pulmonary disease within the
past year

Neurologic

- No pre-existing peripheral neuropathy ≥ grade 2

- No uncontrolled seizure disorder

- No active neurological disease

Other

- No prior severe hypersensitivity reaction to docetaxel or other drugs formulated with
polysorbate 80

- No other invasive malignancy within the past 3 years except nonmelanoma skin cancer

- No other concurrent illness that would preclude study participation

- No concurrent psychiatric illness that would preclude study participation

- No other concurrent physical condition (e.g., infectious disease) that would preclude
study participation

- No prisoners

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for 3 months after study
participation

PRIOR CONCURRENT THERAPY:

Biologic therapy

- No prior anti-epidermal growth factor receptor antibody therapy

Chemotherapy

- More than 3 years since prior cytotoxic chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- No prior head and neck radiotherapy

- No concurrent intensity-modulated radiotherapy

Surgery

- See Disease Characteristics

Other

- No prior tyrosine kinase inhibitor therapy

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Outcome Measure:

Disease-free survival

Safety Issue:

No

Principal Investigator

Paul M. Harari, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Federal Government

Study ID:

CDR0000360850

NCT ID:

NCT00084318

Start Date:

April 2004

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • stage III squamous cell carcinoma of the oropharynx
  • stage IV squamous cell carcinoma of the oropharynx
  • stage III squamous cell carcinoma of the larynx
  • stage IV squamous cell carcinoma of the larynx
  • stage III lymphoepithelioma of the oropharynx
  • stage IV lymphoepithelioma of the oropharynx
  • Carcinoma
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Akron City HospitalAkron, Ohio  44304
Roswell Park Cancer InstituteBuffalo, New York  14263
Memorial Sloan-Kettering Cancer CenterNew York, New York  10021
Mayo Clinic ScottsdaleScottsdale, Arizona  85259
Mayo Clinic - JacksonvilleJacksonville, Florida  32224
Mayo Clinic Cancer CenterRochester, Minnesota  55905
Cardinal Bernardin Cancer Center at Loyola University Medical CenterMaywood, Illinois  60153-5500
CCOP - Upstate CarolinaSpartanburg, South Carolina  29303
Hurley Medical CenterFlint, Michigan  48503
CCOP - Kansas CityKansas City, Missouri  64131
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
CCOP - Mount Sinai Medical CenterMiami Beach, Florida  33140
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
Genesys Hurley Cancer InstituteFlint, Michigan  48503
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
United HospitalSt. Paul, Minnesota  55102
Ridgeview Medical CenterWaconia, Minnesota  55387
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Gundersen Lutheran Cancer Center at Gundersen Lutheran Medical CenterLa Crosse, Wisconsin  54601
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
Massachusetts General Hospital Cancer CenterBoston, Massachusetts  02114
Rapid City Regional HospitalRapid City, South Dakota  57709
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
Providence Saint Joseph Medical Center - BurbankBurbank, California  91505
CCOP - Bay Area Tumor InstituteOakland, California  94609-3305
Memorial Hospital of South BendSouth Bend, Indiana  46601
Reading Hospital and Medical CenterReading, Pennsylvania  19612-6052
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
CCOP - GreenvilleGreenville, South Carolina  29615
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
University of Colorado Cancer Center at University of Colorado Health Sciences CenterDenver, Colorado  80010
University of Miami Sylvester Comprehensive Cancer CenterMiami, Florida  33136
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
CCOP - Grand RapidsGrand Rapids, Michigan  49503
Siteman Cancer Center at Barnes-Jewish HospitalSaint Louis, Missouri  63110
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
Charles M. Barrett Cancer Center at University HospitalCincinnati, Ohio  45267-0526
Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State UniversityColumbus, Ohio  43210-1240
Kimmel Cancer Center at Thomas Jefferson University - PhiladelphiaPhiladelphia, Pennsylvania  19107
CCOP - Scott and White HospitalTemple, Texas  76508
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
CCOP - St. Louis-Cape GirardeauSaint Louis, Missouri  63141
CCOP - Virginia Mason Research CenterSeattle, Washington  98101
Utah Valley Regional Medical Center - ProvoProvo, Utah  84604
Veterans Affairs Medical Center - RichmondRichmond, Virginia  23249
University of California Davis Cancer CenterSacramento, California  95817
Dana-Farber/Harvard Cancer Center at Dana Farber Cancer InstituteBoston, Massachusetts  02115
Mobile Infirmary Medical CenterMobile, Alabama  36640-0460
Markey Cancer Center at University of Kentucky Chandler Medical CenterLexington, Kentucky  40536-0084
Cancer Research Center at Boston Medical CenterBoston, Massachusetts  02118
Josephine Ford Cancer Center at Henry Ford HospitalDetroit, Michigan  48202
Thompson Cancer Survival CenterKnoxville, Tennessee  37916
Blumenthal Cancer Center at Carolinas Medical CenterCharlotte, North Carolina  28232-2861
Hulston Cancer Center at Cox Medical Center SouthSpringfield, Missouri  65807
St. John's Regional Health CenterSpringfield, Missouri  65804
McDowell Cancer Center at Akron General Medical CenterAkron, Ohio  44307
M.D. Anderson Cancer Center at University of TexasHouston, Texas  77030
Latter Day Saints HospitalSalt Lake City, Utah  84143
Loma Linda University Cancer Institute at Loma Linda University Medical CenterLoma Linda, California  92354
Curtis & Elizabeth Anderson Cancer Institute at Memorial Health University Medical CenterSavannah, Georgia  31403-3089
SUNY Upstate Medical University HospitalSyracuse, New York  13210
Mission Hospitals - Memorial CampusAsheville, North Carolina  28801
Hollings Cancer Center at Medical University of South CarolinaCharleston, South Carolina  29425
St. Vincent Hospital Regional Cancer CenterGreen Bay, Wisconsin  54307-3508
Saint Peter's University HospitalNew Brunswick, New Jersey  08901-1780
Mount Nittany Medical CenterState College, Pennsylvania  16803
St. Mary's Hospital Medical Center - Green BayGreen Bay, Wisconsin  54303
Green Bay Oncology, Limited at St. Mary's HospitalGreen Bay, Wisconsin  54303
Bay Area Cancer Care Center at Bay Area Medical CenterMarinette, Wisconsin  54143
Torrance Memorial Medical CenterTorrance, California  90505
Tallahassee Memorial HospitalTallahassee, Florida  32308
Baptist Cancer Institute - JacksonvilleJacksonville, Florida  32207
Saint Anthony's Hospital at Saint Anthony's Health CenterAlton, Illinois  62002
Good Samaritan Regional Health CenterMt. Vernon, Illinois  62864
Southeast Missouri Regional Cancer Center at Southeast Missouri HospitalGape Girardeau, Missouri  63701
David C. Pratt Cancer Center at St. John's MercySt. Louis, Missouri  63141
Wayne Memorial Hospital, IncorporatedGoldsboro, North Carolina  27534
Cottonwood Hospital Medical CenterMurray, Utah  84107
McKay-Dee Hospital CenterOgden, Utah  84403
Utah Cancer Specialists at UCS Cancer CenterSalt Lake City, Utah  84106
University Cancer Center at University of Washington Medical CenterSeattle, Washington  98195
Lakeland Cancer Care Center at Lakeland Hospital - St. JosephSaint Joseph, Michigan  49085
Virginia Commonwealth University Massey Cancer CenterRichmond, Virginia  23298-0037
Huntsman Cancer Institute at University of UtahSalt Lake City, Utah  84112
Elkhart General HospitalElkhart, Indiana  46515
Fox Chase Virtua Health Cancer Program at Virtua Memorial Hospital MarltonMarlton, New Jersey  08053
Fox Chase Virtua Health Cancer Program at Virtua West JerseyVoorhees, New Jersey  08043
Hillcrest Cancer Center at Hillcrest HospitalMayfield Heights, Ohio  44124
Rosenfeld Cancer Center at Abington Memorial HospitalAbington, Pennsylvania  19001
Fox Chase Cancer Center - PhiladelphiaPhiladelphia, Pennsylvania  19111-2497
Michael & Dianne Bienes Comprehensive Cancer Center at Holy Cross HospitalFort Lauderdale, Florida  33308
Ella Milbank Foshay Cancer Center at Jupiter Medical CenterJupiter, Florida  33458
Ingalls Cancer Care Center at Ingalls Memorial HospitalHarvey, Illinois  60426
Center for Cancer Therapy at LaPorte Hospital and Health ServicesLa Porte, Indiana  46350
St. Joseph Mercy Cancer Center at St. Joseph Mercy HospitalAnn Arbor, Michigan  48106-0995
Upper Michigan Cancer Center at Marquette General HospitalMarquette, Michigan  49855
Virginia Piper Cancer Institute at Abbott-Northwestern HospitalMinneapolis, Minnesota  55407
Hubert H. Humphrey Cancer Center at North Memorial Medical CenterRobbinsdale, Minnesota  55422-2900
Coborn Cancer CenterSaint Cloud, Minnesota  56303
CentraCare Clinic - River CampusSt. Cloud, Minnesota  56303
Park Nicollet Health ServicesSt. Louis Park, Minnesota  55416
Saint Francis Medical CenterCape Girardeau, Missouri  63701
Iredell Memorial HospitalStatesville, North Carolina  28677
Forsyth Regional Cancer Center at Forsyth Medical CenterWinston-Salem, North Carolina  27103
Bryn Mawr HospitalBryn Mawr, Pennsylvania  19010
Lankenau Cancer Center at Lankenau HospitalWynnewood, Pennsylvania  19096
Bon Secours St. Francis Health SystemGreenville, South Carolina  29601
Christine LaGuardia Phillips Cancer Center at Wellmont Holston Valley Medical CenterKingsport, Tennessee  37662
Dixie Regional Medical Center - East CampusSaint George, Utah  84770
Danville Regional Medical CenterDanville, Virginia  24541
Green Bay Oncology, Limited at St. Vincent HospitalGreen Bay, Wisconsin  54301-3526
Providence Holy Cross Cancer CenterMission Hills, California  91346-9600
H. Lee Moffitt Cancer Center and Research Institute at University of South FloridaTampa, Florida  33612
Northeast Georgia Medical CenterGainesville, Georgia  30501
Wendt Regional Cancer Center at Finley HospitalDubuque, Iowa  52001
Tulane Cancer CenterNew Orleans, Louisiana  70112
Regional Cancer Center at Singing River HospitalPascagoula, Mississippi  39581
All Saints Cancer Center at All Saints HealthcareRacine, Wisconsin  53405
John B. Amos Cancer CenterColumbus, Georgia  31904
Leo W. Jenkins Cancer Center at ECU Medical SchoolGreenville, North Carolina  27834
Guthrie Cancer Center at Guthrie Clinic SayreSayre, Pennsylvania  18840
York Cancer Center at Apple Hill Medical CenterYork, Pennsylvania  17405
St. Joseph Cancer CenterBellingham, Washington  98225
Schiffler Cancer Center at Wheeling HospitalWheeling, West Virginia  26003
University of Minnesota Medical Center & Children's Hospital - FairviewMinneapolis, Minnesota  55455
Methodist Cancer Center at Methodist Hospital - OmahaOmaha, Nebraska  68114
Oregon Health & Science University Cancer InstitutePortland, Oregon  97239-3098
Arizona Oncology Services FoundationPhoenix, Arizona  85013
Radiological Associates of Sacramento Medical Group, IncorporatedSacramento, California  95815
Hospital of Saint RaphaelNew Haven, Connecticut  06511
Good Samaritan Cancer Center at Good Samaritan HospitalKearney, Nebraska  68848-1990
Long Island College HospitalBrooklyn, New York  11201
Mercy Cancer Institute at Mercy HospitalPittsburgh, Pennsylvania  15219
Gibbs Regional Cancer Center at Spartanburg Regional Medical CenterSpartanburg, South Carolina  29303
Dana-Farber/Brigham and Women's Cancer CenterBoston, Massachusetts  02115
Cancer Institute at St. John's HospitalSpringfield, Illinois  62701
Lacks Cancer Center at Saint Mary's Health CareGrand Rapids, Michigan  49503
Solano Radiation Oncology CenterVacaville, California  95687
Lynn Regional Cancer Center at Boca Raton Community Hospital - Main CenterBoca Raton, Florida  33486
Mercy General HospitalSacramento, California  95819
Virginia G. Piper Cancer Center at Scottsdale Healthcare - SheaScottsdale, Arizona  85260
Virginia G. Piper Cancer Center at Scottsdale Healthcare - OsbornScottsdale, Arizona  85251
Cancer Center of Paoli Memorial HospitalPaoli, Pennsylvania  19301-1792
Dale and Frances Hughes Cancer Center at Pocono Medical CenterEast Stroudsburg, Pennsylvania  18301
J. Phillip Citta Regional Cancer Center at Community Medical CenterToms River, New Jersey  08755
Cancer Institute of New Jersey at Cooper University Hospital - CamdenCamden, New Jersey  08103
Hudner Oncology Center at Saint Anne's Hospital - Fall RiverFall River, Massachusetts  02721
Auburn Radiation OncologyAuburn, California  95603
Radiation Oncology Centers - Cameron ParkCameron Park, California  95682
Radiation Oncology Center - RosevilleRoseville, California  95661
Mercy Cancer Center at Mercy San Juan Medical CenterCarmichael, California  95608
M.D. Anderson Cancer Center OrlandoOrlando, Florida  32806
John D. Cronin Cancer CenterLexington, Kentucky  40504