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Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers


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

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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 CenterChicago, Illinois  60637
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel HillChapel Hill, North Carolina  27599-7570
Robert H. Lurie Comprehensive Cancer Center at Northwestern UniversityChicago, Illinois  60611
Rush Cancer Institute at Rush University Medical CenterChicago, Illinois  60612