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Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With Stages III/IV Head and Neck Squamous Cell Carcinoma


Phase 3
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

Trial Information

Phase III Randomized Study of Adjuvant Biologic Therapy in Patients With Stages III/IV Head and Neck Squamous Cell Carcinoma


OBJECTIVES:

- Determine the efficacy of adjuvant isotretinoin, interferon alfa, and vitamin E, in
terms of incidence of primary disease recurrence and secondary primary tumor
development, in patients with stage III or IV squamous cell carcinoma of the head and
neck previously treated with definitive surgical excision and/or postoperative
radiotherapy.

- Determine the qualitative and quantitative toxicity of this regimen in these patients.

- Compare the overall and disease-free survival of patients treated with this regimen vs
those who undergo observation only.

- Determine whether alterations of p53 gene, retinoic acid receptors, retinoid-regulated
gene, and interferon-responsive genes are associated with clinical outcome in these
patients.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to T
stage (T1 or T2 vs T3 or T4), N stage (N0 or N1 vs N2 or N3), prior therapy (complete tumor
resection vs resection and radiotherapy/chemoradiotherapy vs radiotherapy or
chemoradiotherapy alone), and prior chemotherapy (yes vs no). Patients are randomized to 1
of 2 treatment arms.

- Arm I: Patients receive oral isotretinoin once daily, interferon alfa subcutaneously 3
times weekly, and oral vitamin E 3 times daily. Treatment repeats every month for 12
courses (1 year) in the absence of disease recurrence or unacceptable toxicity.

- Arm II: Patients undergo observation only for 1 year. Patients are followed every 3
months for 2 years and then every 6 months for 3 years.

PROJECTED ACCRUAL: A total of 376 patients (188 per treatment arm) will be accrued for this
study within 3.75 years.

Inclusion Criteria


DISEASE CHARACTERISTICS:

- Histologically confirmed squamous cell carcinoma of the head and neck

- Primary site must be within the oral cavity, oropharynx, larynx, or hypopharynx

- Stage III or IV primary lesion at diagnosis

- No distant metastatic disease at diagnosis

- No multiple primary lesions

- Currently disease-free after treatment with 1 of the following:

- Complete tumor resection

- Radiotherapy or chemoradiotherapy alone*

- Resection followed by radiotherapy/chemoradiotherapy*

- No more than 4-16 weeks since prior surgery and/or radiotherapy/chemoradiotherapy
NOTE: *Radiotherapy must have been 70-72 Gy in 1.8-2.0 Gy fractions to the primary
tumor and clinically positive neck nodes and 44-50 Gy in 1.8-2.0 Gy fractions to
clinically negative nodes, including the lower neck

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 1,500/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- AST and ALT no greater than 2 times upper limit of normal (ULN)

- Alkaline phosphatase no greater than 2 times ULN

Renal

- Creatinine no greater than 1.2 mg/dL

Other

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception for 1 month prior to, during, and
for 1 month after study therapy

- Electrolytes normal

- Fasting serum triglyceride level no greater than 2 times ULN (anti-triglyceride
medication allowed)

- No other malignancy within the past 2 years except localized basal cell or squamous
cell skin cancer

- No other concurrent medical condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- See Disease Characteristics

- At least 4 weeks since prior chemotherapy and recovered

- Prior neoadjuvant chemotherapy allowed

- Prior chemotherapy administered concurrently with radiotherapy allowed

- No other concurrent chemotherapy

Endocrine therapy

- Not specified

Radiotherapy

- See Disease Characteristics

- Recovered from prior radiotherapy

Surgery

- See Disease Characteristics

- Recovered from prior surgery

Other

- No history of megadose vitamin A (more than 25,000 I.U.)

- No other clinical trial enrollment that would preclude adjuvant systemic therapy

- No concurrent vitamin supplements containing vitamin A

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Treatment

Principal Investigator

Dong M. Shin, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Winship Cancer Institute of Emory University

Authority:

United States: Federal Government

Study ID:

CDR0000271174

NCT ID:

NCT00054561

Start Date:

August 2003

Completion Date:

Related Keywords:

  • Head and Neck Cancer
  • stage III squamous cell carcinoma of the lip and oral cavity
  • stage IV squamous cell carcinoma of the lip and oral cavity
  • 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 squamous cell carcinoma of the hypopharynx
  • stage IV squamous cell carcinoma of the hypopharynx
  • Carcinoma, Squamous Cell
  • Head and Neck Neoplasms

Name

Location

Mayo Clinic Cancer CenterRochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research InstituteTampa, Florida  33612
Indiana University Cancer CenterIndianapolis, Indiana  46202-5265
University of Minnesota Cancer CenterMinneapolis, Minnesota  55455
Fox Chase Cancer CenterPhiladelphia, Pennsylvania  19111
CCOP - WichitaWichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer ConsortiumOmaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research FoundationLas Vegas, Nevada  89106
CCOP - Christiana Care Health ServicesWilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur)Decatur, Georgia  30033
CCOP - Illinois Oncology Research AssociationPeoria, Illinois  61602
CCOP - Carle Cancer CenterUrbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush)Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research AssociationDes Moines, Iowa  50309-1016
Beth Israel Deaconess Medical CenterBoston, Massachusetts  02215
CCOP - KalamazooKalamazoo, Michigan  49007-3731
CCOP - Metro-MinnesotaSaint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East OrangeEast Orange, New Jersey  07018-1095
CCOP - Northern New JerseyHackensack, New Jersey  07601
Hahnemann University HospitalPhiladelphia, Pennsylvania  19102-1192
CCOP - Michigan Cancer Research ConsortiumAnn Arbor, Michigan  48106
West Michigan Cancer CenterKalamazoo, Michigan  49007-3731
CCOP - DuluthDuluth, Minnesota  55805
Penn State Cancer Institute at Milton S. Hershey Medical CenterHershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of PennsylvaniaPhiladelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer CenterMilwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology ProjectCedar Rapids, Iowa  52403-1206
CCOP - OchsnerNew Orleans, Louisiana  70121
CCOP - Merit Care HospitalFargo, North Dakota  58122
CCOP - Sioux Community Cancer ConsortiumSioux Falls, South Dakota  57105-1080
University of Alabama at Birmingham Comprehensive Cancer CenterBirmingham, Alabama  35294-3300
NYU School of Medicine's Kaplan Comprehensive Cancer CenterNew York, New York  10016
CCOP - Central IllinoisSpringfield, Illinois  62526
CCOP - ColumbusColumbus, Ohio  43206
CCOP - MainLine HealthWynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - MadisonMadison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer CenterMadison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki)Milwaukee, Wisconsin  53295
CCOP - EvanstonEvanston, Illinois  60201
CCOP - Northern Indiana CR ConsortiumSouth Bend, Indiana  46601
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical CenterLebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSCAlbuquerque, New Mexico  87131
MetroHealth's Cancer Care Center at MetroHealth Medical CenterCleveland, Ohio  44106
CCOP - Geisinger Clinic and Medical CenterDanville, Pennsylvania  17822-2001
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical CenterNashville, Tennessee  37232-2516
CCOP - Scott and White HospitalTemple, Texas  76508
Veterans Affairs Medical Center - Lakeside ChicagoChicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New YorkNew York, New York  10010
CCOP - St. Vincent Hospital Cancer Center, Green BayGreen Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer CenterCleveland, Ohio  44195
Veterans Affairs Medical Center - WichitaWichita, Kansas  67218
MBCCOP - LSU Health Sciences CenterNew Orleans, Louisiana  70112
CCOP - OklahomaTulsa, Oklahoma  74136
Veterans Affairs Medical Center - PittsburghPittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - MiamiMiami, Florida  33125
Veterans Affairs Medical Center - MinneapolisMinneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo AltoPalo Alto, California  94304
City of Hope Comprehensive Cancer CenterDuarte, California  91010
Albert Einstein Clinical Cancer CenterBronx, New York  10461
John Stoddard Cancer Center at Iowa Methodist Medical CenterDes Moines, Iowa  50309
Midlands Cancer Center at Midlands Community HospitalPapillion, Nebraska  68128-4157
Hillman Cancer Center at University of Pittsburgh Cancer InstitutePittsburgh, Pennsylvania  15236
Veterans Affairs Medical Center - BrooklynBrooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley)Tampa, Florida  33612
Tufts - New England Medical CenterBoston, Massachusetts  02111
Stanford Cancer Center at Stanford University Medical CenterStanford, California  94305
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville CampusNashville, Tennessee  37212
CCOP - Toledo Community HospitalToledo, Ohio  43623-3456
Winship Cancer Institute of Emory UniversityAtlanta, Georgia  30322
CCOP - Marshfield Clinic Research FoundationMarshfield, Wisconsin  54449
MBCCOP - Howard University Cancer CenterWashington, District of Columbia  20060
Cancer Institute of New Jersey at Robert Wood Johnson University HospitalNew Brunswick, New Jersey  08903
MBCCOP-Our Lady of Mercy Cancer CenterBronx, New York  10466
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Decatur Memorial Hospital Cancer Care InstituteDecatur, Illinois  62526
Veterans Affairs Medical Center - GainesvilleGainesville, Florida  32608-1197
John Stoddard Cancer Center at Iowa Lutheran HospitalDes Moines, Iowa  50316-2301
Mercy Cancer Center at Mercy Medical Center - Des MoinesDes Moines, Iowa  50314
Burgess Health CenterOnawa, Iowa  51040
Veterans Affairs Medical Center - OmahaOmaha, Nebraska  68105
CCOP - Mayo Clinic Scottsdale Oncology ProgramScottsdale, Arizona  85259