Clinical trial · Interventional
Celecoxib and Radiation Therapy in Treating Patients With Locally Advanced Non-Small Cell Lung Cancer
A Phase I/II Trial of a COX-2 Inhibitor, Celebrex (Celecoxib), [National Screening Committee# 719627] With Limited Field Radiation for Intermediate Prognosis Patients With Locally Advanced Non-Small Cell Lung Cancer, With Analysis of Prognostic Factors
NCT00046839CI-TRIAL-00019825completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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: Radiation therapy uses high-energy x-rays to damage tumor cells. Celecoxib may stop the growth of tumor cells by stopping blood flow to the tumor and may make the tumor cells more sensitive to radiation therapy. PURPOSE: Phase I/II trial to study the effectiveness of combining celecoxib with radiation therapy in treating patients who have locally advanced non-small cell lung cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Lung Cancer | Malignant Lung Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Phase I: Celecoxib 200mg BID + RT
- description
- COX-2 Inhibitor: Celecoxib 200 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
- interventionNames
- Drug: celecoxib
- Radiation: radiation therapy
- type
- EXPERIMENTAL
- label
- Phase I: Celecoxib 400mg BID + RT
- description
- COX-2 Inhibitor: Celecoxib 400 mg b.i.d, 7 days/week begins 5 days prior to start of radiation therapy (RT). Once RT begins, Celecoxib a.m. dose 1-2 hours prior to RT. Administer for 2 years or until disease progression. Concurrent Radiation Therapy: 2 Gy daily, 30-33 fractions, 5 days/week for 6-7 weeks, for a total dose of 60-66 Gy; or 3 Gy daily, 15 fractions, 5 days/week for 3-4 weeks for a total dose of 45 Gy.
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed non-small cell lung cancer * Inoperable stage IIB OR * Unresectable stage IIIA or IIIB * No evidence of hematogenous metastases PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Zubrod 2 AND more than 5% weight loss over the past 3 months OR * Zubrod 0-1 AND less than 5% weight loss over the past 3 months and refuses chemotherapy or are medically unable to tolerate combined modality therapy Life expectancy * Not specified Hematopoietic * Not specified Hepatic * Bilirubin no greater than 2 times upper limit of normal * International Normalized Ratio (INR) no greater than 3.0 if taking warfarin Renal * Creatinine clearance at least 50 mL/min Other * No active gastrointestinal ulcers or bleeding within the past 3 months * No other malignancy within the past 3 years except nonmelanoma skin cancer * No known hypersensitivity to celecoxib * No prior allergic-type reactions to sulfonamides * No prior asthma, urticaria, or allergic-type reactions to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs) * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * No prior neoadjuvant chemotherapy * No concurrent chemotherapy Endocrine therapy * No concurrent corticosteroids Radiotherapy * No prior thoracic radiotherapy Surgery * No prior complete or subtotal tumor resection Other * No concurrent NSAIDs, lithium, furosemide, or angiotensin-converting enzyme inhibitors * Concurrent aspirin (325 mg/day) for cardioprotection allowed
References
Publications (1)
- RESULTGore E, Bae K, Langer C, Extermann M, Movsas B, Okunieff P, Videtic G, Choy H. Phase I/II trial of a COX-2 inhibitor with limited field radiation for intermediate prognosis patients who have locally advanced non-small-cell lung cancer: radiation therapy oncology group 0213. Clin Lung Cancer. 2011 Mar;12(2):125-30. doi: 10.1016/j.cllc.2011.03.007. Epub 2011 Apr 11. PMID 21550559