Clinical trial · Interventional
Celecoxib in Treating Patients With Early-Stage Head and Neck Cancer or Non-Small Cell Lung Cancer
Pilot Randomized Trial Of Adjuvant Celecoxib In Patients With Early Stage Head And Neck And Non-Small Cell Lung Cancers
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| adjuvant therapy | Procedure | — | UNRESOLVED |
| celecoxib | Drug | Celecoxib | ALIAS |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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 lithiumReferences
Publications (0)
Data not yet available