A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
18 Years
N/A
Both
Head and Neck Cancer
Trial Information
A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck
OBJECTIVES:
Primary
- Determine the antiangiogenic effects of PEG-interferon alfa-2b, in terms of pre- and
post-treatment levels of microvessel density (MVD), endothelial cell apoptosis,
vascular endothelial growth factor (VEGF), interleukin-8, basic fibroblast growth
factor (bFGF), Nuclear Factor-KappaB (NF-KB), matrix metalloproteinase/MMP-9, and NF-KB
in biopsy specimens, from patients with resectable stage II-IV squamous cell carcinoma
of the head and neck.
Secondary
- Determine the toxicity profile of this drug in these patients.
- Determine the clinical response in patients treated with this drug.
OUTLINE: This is a randomized, controlled study. Patients are randomized to 1 of 4 treatment
arms.
- Arm I: Patients undergo surgery within 3 weeks after randomization.
- Arm II: Patients receive PEG-interferon alfa-2b subcutaneously on days 1, 8, and 15.
- Arm III: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose.
- Arm IV: Patients receive PEG-interferon alfa-2b as in arm II but at a higher dose than
in arm III.
In arms II, III, and IV, patients undergo surgery within 1 week after completion of
PEG-interferon alfa-2b.
After completion of study treatment, patients are followed for up to 30 days.
PROJECTED ACCRUAL: A maximum of 72 patients will be accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed squamous cell carcinoma of the head and neck
- Stage II, III, or IV disease
- One of the following primary tumor sites:
- Oral cavity
- Oropharynx
- Hypopharynx
- Larynx
- Resectable disease
- Scheduled to undergo surgery as primary treatment
- Distant metastases or a second primary tumor allowed provided tumor deemed
resectable by the surgeon
- No squamous cell carcinoma of the nasopharynx or skin
PATIENT CHARACTERISTICS:
- Eastern Cooperative Oncology Group (ECOG) performance status 0-2
- White Blood Cells (WBC) > 3,000/mm^3
- Platelet count ≥ 150,000/mm^3
- Hemoglobin ≥ 10 g/dL
- Transfusion and/or epoetin alfa support allowed provided it is given ≥ 1 week
before study entry AND the patient is stable
- Bilirubin < 1.5 times upper limit of normal (ULN)
- serum glutamic pyruvic transaminase (SGPT) ≤ 5 times ULN
- Creatinine < 1.5 times ULN
- No hemolytic anemia
- No hemoglobinopathies (e.g., thalassemia)
- No prior or current ascites
- No bleeding varices
- No other evidence of decompensated liver disease
- No symptomatic ischemic heart disease
- No symptomatic congestive heart failure
- No other uncontrolled heart condition
- No chronic obstructive pulmonary disease
- No documented pulmonary hypertension
- No other chronic pulmonary disease
- No known HIV positivity
- No AIDS-related illness
- No active uncontrolled infection
- No immunologically mediated disease, including any of the following:
- Inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis)
- Rheumatoid arthritis
- Idiopathic thrombocytopenia purpura
- Systemic lupus erythematosus
- Autoimmune hemolytic anemia
- Scleroderma
- Severe psoriasis
- No Central Nervous System (CNS) trauma
- No confusion or disorientation
- No active seizure disorders requiring medication
- No spontaneous encephalopathy
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception
- No pre-existing uncontrolled thyroid abnormality
- No poorly controlled diabetes mellitus
- No history of major psychiatric illness that would prelude giving informed consent
- No nonmalignant systemic disease that would preclude study participation
PRIOR CONCURRENT THERAPY:
- More than 4 weeks since prior biologic therapy and recovered
- More than 4 weeks since prior chemotherapy and recovered
- More than 4 weeks since prior radiotherapy and recovered
- More than 4 weeks since prior surgery
- No prior interferon
- No other concurrent immunotherapy
- No concurrent chemotherapy
- No concurrent hormonal antineoplastic therapy
- No concurrent systemic corticosteroids
- No concurrent radiotherapy
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
Outcome Measure:
Response rate
Outcome Time Frame:
3 weeks following treatment
Safety Issue:
No
Principal Investigator
Roy S. Herbst, MD, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
M.D. Anderson Cancer Center
Authority:
United States: Institutional Review Board
Study ID:
CDR0000441020
NCT ID:
NCT00276523
Start Date:
February 2004
Completion Date:
March 2006
Related Keywords:
- Head and Neck Cancer
- stage II squamous cell carcinoma of the lip and oral cavity
- stage III squamous cell carcinoma of the lip and oral cavity
- stage IV squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the oropharynx
- stage III squamous cell carcinoma of the oropharynx
- stage IV squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the hypopharynx
- stage III squamous cell carcinoma of the hypopharynx
- stage IV squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage III squamous cell carcinoma of the larynx
- stage IV squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the hypopharynx
- recurrent squamous cell carcinoma of the larynx
- recurrent squamous cell carcinoma of the lip and oral cavity
- recurrent squamous cell carcinoma of the oropharynx
- Head and Neck Neoplasms
Name | Location |
|---|---|
| M.D. Anderson Cancer Center at University of Texas | Houston, Texas 77030 |
