Upstate Active Clinical Trials Seeking Participants
Study title
A Randomized Phase III Double Blind Trial Evaluating Selective COX-2 Inhibition in COX-2 Expressing Advanced Non-Small Cell Lung Cancer
IRB number
CIRB#112
What is the purpose of the study?
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 advanced non-small cell lung cancer are usually not effective in preventing the cancer from growing. In this study, we will test a sample of participants 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.
Who is eligible?
Diagnosis of advanced non-small cell lung cancer, no prior treatment except for surgery or radiation, no clinically significant cardiac disease, good general health, and adequate bone marrow, liver and kidney function tests.
What is involved if I participate?
- How long is the study?
We think treatment will last about 5 months, but could last longer depending upon how participants disease responds and what kind of side-effects they experience. Participants and their doctors may decide to continue on the celecoxib/placebo if, after 6 cycles of chemotherapy, their tumor is shrinking or staying the same.Following treatment, follow-up examinations will be done at least every 2 months for 2 years and then at least every 6 months for 3 years - Is transportation provided or reimbursed?
No - Is parking provided or reimbursed?
No - What tests and procedures are involved?
Physical exam, Blood tests for blood counts, electrolytes, kidney function, and liver function; Brain MRI if indicated, Chest/abdominal CT scan, testing of tumor specimen for COX-2.
Who is the doctor administering the study?
Stephen Graziano, MD
Where will the study take place?
University Hospital, Hematology/Oncology Clinics in Oswego, Oneida and Hill Medical Center
Over what time period is the study scheduled to run?
3/2010-5/2014
Who can I contact for more information?
- Name: Linda Spillett
- Phone: 315-464-8237
- Email: spilletl@upstate.edu
- Fax: 315-464-8288
If you are interested in this trial, please contact the study coordinator or investigator noted above.
