Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
18 Years
N/A
Both
Head and Neck Cancer, Lung Cancer
Trial Information
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
OBJECTIVES:
- Compare the rate of new malignancies (recurrences and second primary tumors) in
patients with early-stage head and neck cancer or non-small cell lung cancer treated
with celecoxib vs placebo.
- Compare the event-free and overall survival of patients treated with this drug vs
placebo.
- Determine the toxic effects associated with long-term use of celecoxib in these
patients.
- Correlate cyclooxygenase-2 and transforming growth factor (TGF)-beta expression and
CYP2C9 and TGF-beta genotypes with the rate of new malignancies and survival of
patients treated with this drug vs placebo.
OUTLINE: This is a randomized, placebo-controlled, double-blind, multicenter study. Patients
are stratified according to smoking history (active smokers [including those who quit within
1 year of diagnosis] vs former smokers vs non-smokers), tumor type (lung cancer vs head and
neck cancer), and stage (I vs II for head and neck cancer or T1 vs T2 for lung cancer).
Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral celecoxib twice daily.
- Arm II: Patients receive oral placebo twice daily. In both arms, treatment continues
for 24 months in the absence of disease recurrence or unacceptable toxicity.
Patients are followed every 6 months for 5 years or until disease recurrence.
PROJECTED ACCRUAL: A total of 121 patients (approximately 60 per treatment arm) will be
accrued for this study.
Inclusion Criteria
DISEASE CHARACTERISTICS:
- One of the following histologically confirmed diagnoses:
- Stage I non-small cell lung cancer (NSCLC)
- No small cell component
- Stage I-II squamous cell cancer of the head and neck
- No WHO type II or III nasopharyngeal cancer
- No sinonasal undifferentiated carcinoma
- No evidence of disease
- Must have undergone surgery or radiotherapy with curative intent within the past 4-24
weeks
PATIENT CHARACTERISTICS:
Age
- 18 and over
Performance status
- ECOG 0-1
Life expectancy
- Not specified
Hematopoietic
- Platelet count at least 50,000/mm^3
Hepatic
- Bilirubin normal
- AST/ALT no greater than 2 times upper limit of normal
Renal
- Creatinine no greater than 2.0 mg/dL
Cardiovascular
- No uncontrolled hypertension
- No severe congestive heart failure
Pulmonary
- No history of asthma caused by cyclooxygenase-2 (COX-2) inhibitors, nonsteroidal
anti-inflammatory drugs (NSAIDs), salicylates, or sulfonamides
Other
- Not pregnant or nursing
- Negative pregnancy test
- Fertile patients must use effective contraception during and for 3 months after study
participation
- No other prior malignancy (including skin cancer and in situ malignancies)
- No diagnosis of peptic ulcer disease or gastritis/esophagitis within the past 60 days
- No prior hypersensitivity reaction to COX-2 inhibitors, NSAIDs, salicylates, or
sulfonamides
- No other concurrent medical condition that would preclude study compliance
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No cumulative oral or IV corticosteroid use totalling more than 2 weeks within the
past 3 months
- No concurrent oral steroids for more than 2 consecutive weeks
- Concurrent inhaled steroids allowed
Radiotherapy
- See Disease Characteristics
- No prior definitive radiotherapy for stage I NSCLC
Surgery
- See Disease Characteristics
- Prior pneumonectomy or lobectomy with mediastinal lymph node sampling or dissection
for stage I NSCLC allowed
- No prior segmentectomies or wedge resections for stage I NSCLC
Other
- More than 60 days since prior treatment for peptic ulcer disease or
gastritis/esophagitis
- No prior NSAID use within the past 30 days at a frequency of 3 or more times a week
for more than 2 weeks
- No concurrent NSAIDs (including low-dose aspirin)
- No other concurrent COX-2 inhibitors
- No concurrent fluconazole
- No concurrent lithium
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Treatment
Principal Investigator
Athanassios Argiris, MD
Investigator Role:
Study Chair
Investigator Affiliation:
Robert H. Lurie Cancer Center
Authority:
United States: Federal Government
Study ID:
NU 02V2
NCT ID:
NCT00058006
Start Date:
September 2002
Completion Date:
December 2006
Related Keywords:
- Head and Neck Cancer
- Lung Cancer
- stage I non-small cell lung cancer
- stage I squamous cell carcinoma of the hypopharynx
- stage I squamous cell carcinoma of the larynx
- stage I squamous cell carcinoma of the lip and oral cavity
- stage I squamous cell carcinoma of the nasopharynx
- stage I squamous cell carcinoma of the oropharynx
- stage I squamous cell carcinoma of the paranasal sinus and nasal cavity
- stage II squamous cell carcinoma of the hypopharynx
- stage II squamous cell carcinoma of the larynx
- stage II squamous cell carcinoma of the lip and oral cavity
- stage II squamous cell carcinoma of the nasopharynx
- stage II squamous cell carcinoma of the oropharynx
- stage II squamous cell carcinoma of the paranasal sinus and nasal cavity
- salivary gland squamous cell carcinoma
- stage I salivary gland cancer
- stage II salivary gland cancer
- Carcinoma, Non-Small-Cell Lung
- Head and Neck Neoplasms
- Lung Neoplasms
Name | Location |
|---|---|
| University of Chicago Cancer Research Center | Chicago, Illinois 60637 |
| Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | Chapel Hill, North Carolina 27599-7570 |
| Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |
| Rush Cancer Institute at Rush University Medical Center | Chicago, Illinois 60612 |
