A Phase I Study of Concurrent CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)
Celecoxib is a non-steroidal-anti-inflammatory drug (NSAIDS), similar to aspirin or
ibuprofen. Recent studies have shown that celecoxib has antitumor activity when used alone.
It may also increase the tumor sensitivity to radiation, making tumors more responsive to
Before treatment starts, you will have a complete physical exam, including blood (about 2
teaspoons) and urine tests. You will have a chest x-ray, CT/MRI scans, and/or a PET scan.
You may have a bone scan (x-rays of your bones) if your doctor feels it is necessary. You
may also have blood tests, x-rays, biopsy of the tumor, and any other tests which your
physician feels are necessary for your standard of care.
In this study, you will take celecoxib by mouth for 5 days before beginning radiation
therapy. You will continue to receive celecoxib 7 days per week throughout radiation
treatment (about 7 weeks). The amount of drug that you take will depend on what dose level
you are assigned to. The dose levels are 200mg, 400mg, and 800 mg per day. Ten patients
will be treated on each dose level starting at the lower level. You will be required to
fill out a medication diary, documenting the dose of celecoxib you are taking and the time
that you take it.
You will receive cisplatin and CPT-11 by vein on Day 1 of Weeks 2 through 8. Chemotherapy
will be given on an outpatient basis. CPT-11 will be infused by vein over 90 minutes
followed by cisplatin which will be infused for 60 minutes. Because cisplatin can cause
kidney damage, fluids may need to be injected to "flush" the kidneys. Diuretics are given
by vein just before and after receiving cisplatin. So that the physician may better
evaluate kidney function during this time, you may be asked to save urine specimens and to
keep a record of all fluids taken by mouth during the first 24-48 hours after receiving
Radiation therapy will begin on Day 1 of Week 2 and be given at the same time as
chemotherapy. The radiation therapy treatments will be given once a day for 5 days a week,
Monday-Friday. The total treatment time for individual patients will be decided by the
physician, based on the your general condition and stage of disease. The length of the
radiation treatment should be about 7 weeks (35 radiation treatments).
During treatment, you will have blood tests (about 2 teaspoons) every week. You will report
to your physician the degree of sore throat, difficulty swallowing, gastric burning, or any
symptoms that concern you.
You will be taken off study if the disease becomes worse or side effects become very severe.
After treatment is completed, you will return for follow-up visits at one month, every 3
months for 2 years, every 6 months for 3 to 5 years, then once a year for 10 years. At each
follow-up visit, you will have blood (about 2 teaspoons) samples collected for routine lab
tests and you will have a chest x-ray. You will have a CT scan of the chest every 6 months.
Complete lung function tests will also be done. Lung function tests look at the exchange
of the air flow, capacity of the lung, flexibility of the lung, and exchange of oxygen in
carbon dioxide in the lungs.
This is an investigational study. All of the drugs in this study are FDA approved and
commercially available. The use of these drugs in combination is investigational. Between
30 and 40 patients will take part in this study. All will be enrolled at M. D. Anderson.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Maximum Tolerated Dose (MTD) of Celebrex (celecoxib)
12 week treatment; Continuous assessment and determination of dose-limiting toxicities.
Ritsuko R Komaki, MD
M.D. Anderson Cancer Center
United States: Institutional Review Board
|UT MD Anderson Cancer Center||Houston, Texas 77030|