Erlotinib and Celecoxib in Treating Patients With Stage IIIB or Stage IV Recurrent Non-Small Cell Lung Cancer
Completed · Phase 2
Conditions studied: Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer
In brief
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. .
Key facts
- Study ID
- NCT00062101
- Run by
- National Cancer Institute (NCI)
- People needed
- 80
- Starts
- 2004-01-01
- Last updated by the study team
- 2013-06-06
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
Where it is running
- Rush University Medical Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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