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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 Center Rochester, Minnesota  55905
H. Lee Moffitt Cancer Center and Research Institute Tampa, Florida  33612
Indiana University Cancer Center Indianapolis, Indiana  46202-5265
University of Minnesota Cancer Center Minneapolis, Minnesota  55455
Fox Chase Cancer Center Philadelphia, Pennsylvania  19111
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Southern Nevada Cancer Research Foundation Las Vegas, Nevada  89106
CCOP - Christiana Care Health Services Wilmington, Delaware  19899
Veterans Affairs Medical Center - Atlanta (Decatur) Decatur, Georgia  30033
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
Veterans Affairs Medical Center - Indianapolis (Roudebush) Indianapolis, Indiana  46202
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
Beth Israel Deaconess Medical Center Boston, Massachusetts  02215
CCOP - Kalamazoo Kalamazoo, Michigan  49007-3731
CCOP - Metro-Minnesota Saint Louis Park, Minnesota  55416
Veterans Affairs Medical Center - East Orange East Orange, New Jersey  07018-1095
CCOP - Northern New Jersey Hackensack, New Jersey  07601
Hahnemann University Hospital Philadelphia, Pennsylvania  19102-1192
CCOP - Michigan Cancer Research Consortium Ann Arbor, Michigan  48106
West Michigan Cancer Center Kalamazoo, Michigan  49007-3731
CCOP - Duluth Duluth, Minnesota  55805
Penn State Cancer Institute at Milton S. Hershey Medical Center Hershey, Pennsylvania  17033-0850
Abramson Cancer Center of the University of Pennsylvania Philadelphia, Pennsylvania  19104-4283
Medical College of Wisconsin Cancer Center Milwaukee, Wisconsin  53226
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
CCOP - Ochsner New Orleans, Louisiana  70121
CCOP - Merit Care Hospital Fargo, North Dakota  58122
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
University of Alabama at Birmingham Comprehensive Cancer Center Birmingham, Alabama  35294-3300
NYU School of Medicine's Kaplan Comprehensive Cancer Center New York, New York  10016
CCOP - Central Illinois Springfield, Illinois  62526
CCOP - Columbus Columbus, Ohio  43206
CCOP - MainLine Health Wynnewood, Pennsylvania  19096
Veterans Affairs Medical Center - Madison Madison, Wisconsin  53705
University of Wisconsin Comprehensive Cancer Center Madison, Wisconsin  53792
Veterans Affairs Medical Center - Milwaukee (Zablocki) Milwaukee, Wisconsin  53295
CCOP - Evanston Evanston, Illinois  60201
CCOP - Northern Indiana CR Consortium South Bend, Indiana  46601
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center Lebanon, New Hampshire  03756-0002
MBCCOP - University of New Mexico HSC Albuquerque, New Mexico  87131
MetroHealth's Cancer Care Center at MetroHealth Medical Center Cleveland, Ohio  44106
CCOP - Geisinger Clinic and Medical Center Danville, Pennsylvania  17822-2001
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center Nashville, Tennessee  37232-2516
CCOP - Scott and White Hospital Temple, Texas  76508
Veterans Affairs Medical Center - Lakeside Chicago Chicago, Illinois  60611
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Baltimore, Maryland  21231-2410
Veterans Affairs Medical Center - New York New York, New York  10010
CCOP - St. Vincent Hospital Cancer Center, Green Bay Green Bay, Wisconsin  54301
Cleveland Clinic Taussig Cancer Center Cleveland, Ohio  44195
Veterans Affairs Medical Center - Wichita Wichita, Kansas  67218
MBCCOP - LSU Health Sciences Center New Orleans, Louisiana  70112
CCOP - Oklahoma Tulsa, Oklahoma  74136
Veterans Affairs Medical Center - Pittsburgh Pittsburgh, Pennsylvania  15240
Veterans Affairs Medical Center - Miami Miami, Florida  33125
Veterans Affairs Medical Center - Minneapolis Minneapolis, Minnesota  55417
Veterans Affairs Medical Center - Palo Alto Palo Alto, California  94304
City of Hope Comprehensive Cancer Center Duarte, California  91010
Albert Einstein Clinical Cancer Center Bronx, New York  10461
John Stoddard Cancer Center at Iowa Methodist Medical Center Des Moines, Iowa  50309
Midlands Cancer Center at Midlands Community Hospital Papillion, Nebraska  68128-4157
Hillman Cancer Center at University of Pittsburgh Cancer Institute Pittsburgh, Pennsylvania  15236
Veterans Affairs Medical Center - Brooklyn Brooklyn, New York  11209
Veterans Affairs Medical Center - Tampa (Haley) Tampa, Florida  33612
Tufts - New England Medical Center Boston, Massachusetts  02111
Stanford Cancer Center at Stanford University Medical Center Stanford, California  94305
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus Nashville, Tennessee  37212
CCOP - Toledo Community Hospital Toledo, Ohio  43623-3456
Winship Cancer Institute of Emory University Atlanta, Georgia  30322
CCOP - Marshfield Clinic Research Foundation Marshfield, Wisconsin  54449
MBCCOP - Howard University Cancer Center Washington, District of Columbia  20060
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital New Brunswick, New Jersey  08903
MBCCOP-Our Lady of Mercy Cancer Center Bronx, New York  10466
Robert H. Lurie Comprehensive Cancer Center at Northwestern University Chicago, Illinois  60611
Decatur Memorial Hospital Cancer Care Institute Decatur, Illinois  62526
Veterans Affairs Medical Center - Gainesville Gainesville, Florida  32608-1197
John Stoddard Cancer Center at Iowa Lutheran Hospital Des Moines, Iowa  50316-2301
Mercy Cancer Center at Mercy Medical Center - Des Moines Des Moines, Iowa  50314
Burgess Health Center Onawa, Iowa  51040
Veterans Affairs Medical Center - Omaha Omaha, Nebraska  68105
CCOP - Mayo Clinic Scottsdale Oncology Program Scottsdale, Arizona  85259