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Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer

Primary Purpose

Head and Neck Cancer, Lung Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
celecoxib
adjuvant therapy
Sponsored by
Northwestern University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Head and Neck Cancer focused on measuring 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

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Robert H. Lurie Comprehensive Cancer Center at Northwestern University
  • Rush Cancer Institute at Rush University Medical Center
  • University of Chicago Cancer Research Center
  • Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
April 7, 2003
Last Updated
June 7, 2012
Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00058006
Brief Title
Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
Official Title
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
Study Type
Interventional

2. Study Status

Record Verification Date
June 2012
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
December 2006 (Actual)
Study Completion Date
December 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Northwestern University
Collaborators
National Cancer Institute (NCI)

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Chemoprevention therapy is the use of certain drugs to try to prevent the development or recurrence of cancer. The use of celecoxib may be an effective way to prevent the recurrence of stage I or stage II head and neck cancer or stage I non-small cell lung cancer. PURPOSE: This randomized phase II trial is studying celecoxib to see how well it works compared to that of a placebo in preventing disease recurrence in patients with stage I or stage II head and neck cancer or stage I non-small cell lung cancer.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer, Lung Cancer
Keywords
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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Masking
Double
Allocation
Randomized

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
celecoxib
Intervention Type
Procedure
Intervention Name(s)
adjuvant therapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Athanassios Argiris, MD
Organizational Affiliation
Robert H. Lurie Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-3013
Country
United States
Facility Name
Rush Cancer Institute at Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago Cancer Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599-7295
Country
United States

12. IPD Sharing Statement

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Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer

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