Non-Small Cell Lung Cancer Study
Protocol ID
Protocol Description
The purpose of this study is to compare the effects, good and/or bad, of adding an experimental drug, celecoxib, to chemotherapy. This research is being done because current standard treatments for non-small cell lung cancer are usually not effective in preventing the cancer from growing. This study will test a sample of cancer to see if it has an enzyme called COX-2. It is thought that cancers that have high levels of this enzyme may benefit from the addition of celecoxib to standard chemotherapy. In this study research participants will receive standard chemotherapy of either gemcitabine and carboplatin or pemetrexed and carboplatin, depending on the type of non-small cell lung cancer. Along with standard chemotherapy, the participant will get either celecoxib or a placebo (a substance that looks like celecoxib, but contains no medication). We do not know whether or not adding celecoxib to the chemotherapy is beneficial. Celecoxib is not approved by the Food and Drug Administration (FDA) for the treatment of lung caner.
Eligibility Criteria
• Histologically or cytologically documented non-small cell carcinoma of the lung
• Stage IV and selected stage IIIB
• Patients with CNS metastases that are symptomatic must have received therapy and be neurologically stable and off of steroids at least 14days before registration of study.
• Patients must have measurable or non-measurable disease
• No prior chemotherapy, immunotherapy or systemic treatments for non-small cell lung cancer, including adjuvant therapy
• More than 2 weeks since radiation therapy or surgery and completely recovered from these treatments
• Must be 18 or older
• No currently active second malignancy other than non-melanoma skin cancers
• No known hypersensitivity to aspirin, non-steroidal anti-inflammatory agents, or sulfonamides
• No active ulcer disease
• No treatment with other investigational therapy.
• No chronic therapy w/ non-steroidal anti-inflammatory drugs
• No cardiac disease
• Patients must be able to swallow capsules.
• Patients must be non-pregnant and non-nursing
• Blood and/or urine lab tests must meet required values
Primary Investigator(s)
- Haralamnus Raftopoulos, MD