Breast Cancer Clinical Trial

Isotretinoin, Interferon Alfa, and Vitamin E in Treating Patients With Stage III or Stage IV Head and Neck Cancer

Summary

RATIONALE: Drugs used in chemotherapy such as isotretinoin use different ways to stop tumor cells from dividing so they stop growing or die. Interferon alfa may interfere with the growth of tumor cells. Vitamin E may be able to decrease side effects caused by isotretinoin. It is not yet known whether combining isotretinoin and interferon alfa with vitamin E is more effective than observation in preventing recurrence of head and neck cancer after surgery and/or radiation therapy.

PURPOSE: Randomized phase III trial to compare the effectiveness of isotretinoin and interferon alfa combined with vitamin E with that of observation in treating patients who have undergone surgery and/or radiation therapy for stage III or stage IV head and neck cancer.

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Full Description

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.

View Eligibility Criteria

Eligibility 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

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00054561

Recruitment Status:

Completed

Sponsor:

Eastern Cooperative Oncology Group

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There are 82 Locations for this study

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University of Alabama at Birmingham Comprehensive Cancer Center
Birmingham Alabama, 35294, United States
CCOP - Mayo Clinic Scottsdale Oncology Program
Scottsdale Arizona, 85259, United States
City of Hope Comprehensive Cancer Center
Duarte California, 91010, United States
Veterans Affairs Medical Center - Palo Alto
Palo Alto California, 94304, United States
Stanford Cancer Center at Stanford University Medical Center
Stanford California, 94305, United States
CCOP - Christiana Care Health Services
Newark Delaware, 19713, United States
MBCCOP - Howard University Cancer Center
Washington District of Columbia, 20060, United States
Veterans Affairs Medical Center - Gainesville
Gainesville Florida, 32608, United States
Veterans Affairs Medical Center - Miami
Miami Florida, 33125, United States
H. Lee Moffitt Cancer Center and Research Institute
Tampa Florida, 33612, United States
Veterans Affairs Medical Center - Tampa (Haley)
Tampa Florida, 33612, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Veterans Affairs Medical Center - Atlanta (Decatur)
Decatur Georgia, 30033, United States
Veterans Affairs Medical Center - Lakeside Chicago
Chicago Illinois, 60611, United States
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago Illinois, 60611, United States
CCOP - Central Illinois
Decatur Illinois, 62526, United States
Decatur Memorial Hospital Cancer Care Institute
Decatur Illinois, 62526, United States
CCOP - Evanston
Evanston Illinois, 60201, United States
CCOP - Illinois Oncology Research Association
Peoria Illinois, 61615, United States
CCOP - Carle Cancer Center
Urbana Illinois, 61801, United States
Indiana University Cancer Center
Indianapolis Indiana, 46202, United States
Veterans Affairs Medical Center - Indianapolis (Roudebush)
Indianapolis Indiana, 46202, United States
CCOP - Northern Indiana CR Consortium
South Bend Indiana, 46601, United States
CCOP - Cedar Rapids Oncology Project
Cedar Rapids Iowa, 52403, United States
CCOP - Iowa Oncology Research Association
Des Moines Iowa, 50309, United States
John Stoddard Cancer Center at Iowa Methodist Medical Center
Des Moines Iowa, 50309, United States
Mercy Cancer Center at Mercy Medical Center - Des Moines
Des Moines Iowa, 50314, United States
John Stoddard Cancer Center at Iowa Lutheran Hospital
Des Moines Iowa, 50316, United States
Burgess Health Center
Onawa Iowa, 51040, United States
CCOP - Wichita
Wichita Kansas, 67214, United States
Veterans Affairs Medical Center - Wichita
Wichita Kansas, 67218, United States
MBCCOP - LSU Health Sciences Center
New Orleans Louisiana, 70112, United States
CCOP - Ochsner
New Orleans Louisiana, 70121, United States
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore Maryland, 21231, United States
Tufts - New England Medical Center
Boston Massachusetts, 02111, United States
Beth Israel Deaconess Medical Center
Boston Massachusetts, 02215, United States
CCOP - Michigan Cancer Research Consortium
Ann Arbor Michigan, 48106, United States
CCOP - Kalamazoo
Kalamazoo Michigan, 49007, United States
West Michigan Cancer Center
Kalamazoo Michigan, 49007, United States
CCOP - Duluth
Duluth Minnesota, 55805, United States
Veterans Affairs Medical Center - Minneapolis
Minneapolis Minnesota, 55417, United States
University of Minnesota Cancer Center
Minneapolis Minnesota, 55455, United States
Mayo Clinic Cancer Center
Rochester Minnesota, 55905, United States
CCOP - Metro-Minnesota
Saint Louis Park Minnesota, 55416, United States
Veterans Affairs Medical Center - Omaha
Omaha Nebraska, 68105, United States
CCOP - Missouri Valley Cancer Consortium
Omaha Nebraska, 68106, United States
Midlands Cancer Center at Midlands Community Hospital
Papillion Nebraska, 68128, United States
CCOP - Southern Nevada Cancer Research Foundation
Las Vegas Nevada, 89106, United States
Norris Cotton Cancer Center at Dartmouth-Hitchcock Medical Center
Lebanon New Hampshire, 03756, United States
Veterans Affairs Medical Center - East Orange
East Orange New Jersey, 07018, United States
CCOP - Northern New Jersey
Hackensack New Jersey, 07601, United States
Cancer Institute of New Jersey at Robert Wood Johnson University Hospital
New Brunswick New Jersey, 08903, United States
MBCCOP - University of New Mexico HSC
Albuquerque New Mexico, 87131, United States
Albert Einstein Clinical Cancer Center
Bronx New York, 10461, United States
MBCCOP-Our Lady of Mercy Cancer Center
Bronx New York, 10466, United States
Veterans Affairs Medical Center - Brooklyn
Brooklyn New York, 11209, United States
Veterans Affairs Medical Center - New York
New York New York, 10010, United States
NYU School of Medicine's Kaplan Comprehensive Cancer Center
New York New York, 10016, United States
CCOP - Merit Care Hospital
Fargo North Dakota, 58122, United States
MetroHealth's Cancer Care Center at MetroHealth Medical Center
Cleveland Ohio, 44109, United States
Cleveland Clinic Taussig Cancer Center
Cleveland Ohio, 44195, United States
CCOP - Columbus
Columbus Ohio, 43206, United States
CCOP - Toledo Community Hospital
Toledo Ohio, 43623, United States
CCOP - Oklahoma
Tulsa Oklahoma, 74136, United States
CCOP - Geisinger Clinic and Medical Center
Danville Pennsylvania, 17822, United States
Penn State Cancer Institute at Milton S. Hershey Medical Center
Hershey Pennsylvania, 17033, United States
Hahnemann University Hospital
Philadelphia Pennsylvania, 19102, United States
Abramson Cancer Center of the University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Fox Chase Cancer Center
Philadelphia Pennsylvania, 19111, United States
Hillman Cancer Center at University of Pittsburgh Cancer Institute
Pittsburgh Pennsylvania, 15236, United States
Veterans Affairs Medical Center - Pittsburgh
Pittsburgh Pennsylvania, 15240, United States
CCOP - MainLine Health
Wynnewood Pennsylvania, 19096, United States
CCOP - Sioux Community Cancer Consortium
Sioux Falls South Dakota, 57104, United States
Veterans Affairs Medical Center - Tennessee Valley Healthcare System - Nashville Campus
Nashville Tennessee, 37212, United States
Vanderbilt-Ingram Cancer Center at Vanderbilt Medical Center
Nashville Tennessee, 37232, United States
CCOP - Scott and White Hospital
Temple Texas, 76508, United States
CCOP - St. Vincent Hospital Cancer Center, Green Bay
Green Bay Wisconsin, 54307, United States
Veterans Affairs Medical Center - Madison
Madison Wisconsin, 53705, United States
University of Wisconsin Comprehensive Cancer Center
Madison Wisconsin, 53792, United States
CCOP - Marshfield Clinic Research Foundation
Marshfield Wisconsin, 54449, United States
Medical College of Wisconsin Cancer Center
Milwaukee Wisconsin, 53226, United States
Veterans Affairs Medical Center - Milwaukee (Zablocki)
Milwaukee Wisconsin, 53295, United States
Westmead Breast Centre at NSW Breast Cancer Institute
Westmead New South Wales, 2145, Australia
Westmead Hospital
Westmead New South Wales, 2145, Australia
Instituto de Enfermedades Neoplasicas
Lima , 34, Peru
MBCCOP - San Juan
San Juan , 00921, Puerto Rico
Veterans Affairs Medical Center - San Juan
San Juan , 00927, Puerto Rico
San Juan City Hospital
San Juan , 00936, Puerto Rico
Pretoria Academic Hospital
Pretoria , 0001, South Africa

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Study ID:

NCT00054561

Recruitment Status:

Completed

Sponsor:


Eastern Cooperative Oncology Group

How clear is this clinincal trial information?

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