Clinical trial · Interventional
Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
A Phase II Study of OSI 774 (IND Number 63383) in Combination With Celecoxib (Celebrex, Pharmacia) as Second-Line Therapy in Advanced Non-Small Cell Lung Cancer
NCT00062101CI-TRIAL-00010640completedPhase 2ClinicalTrials.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)
This phase II trial is studying how well giving erlotinib together with celecoxib works in treating patients with recurrent stage IIIB or stage IV non-small cell lung cancer. Erlotinib and celecoxib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth. Celecoxib may slow the growth of a tumor by stopping blood flow to the tumor. Combining erlotinib with celecoxib may kill more tumor cells. .
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Recurrent Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIIB Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
| Stage IV Non-small Cell Lung Cancer | Lung Non-Small Cell Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| celecoxib | Drug | Celecoxib | ALIAS |
| erlotinib hydrochloride | Drug | Erlotinib Hydrochloride | ALIAS |
| laboratory biomarker analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Group I (erlotinib hydrochloride, celecoxib)
- description
- Patients receive oral erlotinib once daily and oral celecoxib twice daily.
- interventionNames
- Drug: erlotinib hydrochloride
- Drug: celecoxib
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Group II (erlotinib hydrochloride)
- description
- Patients receive erlotinib as in group 1.
- interventionNames
- Drug: erlotinib hydrochloride
- Other: laboratory biomarker analysis
Primary outcomes (1)
- measure
- Response rate according to the Response Evaluation Criteria in Solid Tumors (RECIST)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically confirmed non-small cell lung cancer * Stage IIIB (malignant pleural effusion only) or IV * Recurrent disease that has progressed after 1 or 2 prior chemotherapy regimens (platinum- or nonplatinum-based) * At least 1 unidimensionally measurable lesion\* * At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan * Must have tissue specimen available for assays * No brain metastases * Performance status - ECOG 0-2 * Performance status - Karnofsky 60-100% * More than 3 months * WBC at least 3,000/mm\^3 * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 * Bilirubin normal * AST/ALT no greater than 2.5 times upper normal limit (ULN) * Creatinine normal * Creatinine clearance at least 60 mL/min * No symptomatic congestive heart failure * No unstable angina pectoris * No cardiac arrhythmia * No prior abnormalities of the cornea (e.g., dry eye syndrome or Sjögren's syndrome) * No congenital abnormality (e.g., Fuch's dystrophy) * No abnormal slit-lamp examination using a vital dye (e.g., fluorescein or Bengal-Rose) * No abnormal corneal sensitivity test (e.g., Schirmer test or similar tear production test) * Able to ingest oral medication * No requirement for IV alimentation * No history of peptic ulcer disease * No active gastrointestinal ulcers * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No other concurrent uncontrolled illness * No ongoing or active infection * No significant traumatic injury within the past 21 days * No psychiatric illness or social situation that would preclude study compliance * No prior allergic reactions to sulfonamides, aspirin, and other nonsteroidal anti-inflammatory drugs * No prior monoclonal antibodies to epidermal growth factor receptor (EGFR) * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin) and recovered * No concurrent chemotherapy * No concurrent glucocorticoids * More than 4 weeks since prior radiotherapy and recovered * More than 21 days since prior major surgery * No prior surgery affecting absorption * No prior EGFR-specific tyrosine kinases * No concurrent anticonvulsants * No other concurrent investigational agents * No concurrent antiretroviral therapy for HIV-positive patients * No concurrent antacids * No concurrent administration of any of the following drugs: * Amiodarone * Chloramphenicol * Cimetidine * Fluvoxamine * Omeprazole * Zafirlukast * Clopidogrel * Cotrimoxazole * Disulfiram * Fluconazole * Fluoxetine * Fluvastatin * Fluvoxamine * Isoniazid * Itraconazole * Ketoconazole * Leflunomide * Metronidazole * Modafinil * Paroxetine * Phenylbutazone * Sertraline * Ticlopidine * Valproic acid
References
Publications (0)
Data not yet available
No reference posted for this study.