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A Randomized Phase II Study of SCH 54031 in Surgically Resectable Squamous Cell Tumors of the Head and Neck


Phase 2
18 Years
N/A
Not Enrolling
Both
Head and Neck Cancer

Thank you

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 TexasHouston, Texas  77030