CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)
- To determine the feasibility, activity, and toxicity of a novel regimen using a concurrent irinotecan (CPT-11)/cisplatin and celecoxib combination for patients with unresectable NSCLC.
- To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecan/cisplatin and concurrent thoracic radiation therapy.
- To correlate the COX-2 expression and other biomarkers with response to the treatment in the tumor from a pretreatment biopsy specimen.
Radiation: Concurrent Thoracic Radiation Therapy
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Phase I Study of Concurrent CPT-11/Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer (NSCLC)|
- Maximum Tolerated Dose (MTD) of Celebrex (celecoxib) [ Time Frame: 12 week treatment; Continuous assessment and determination of dose-limiting toxicities. ] [ Designated as safety issue: Yes ]
|Study Start Date:||September 2003|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
Experimental: CPT-11 + Celecoxib/Cisplatin with RT
CPT-11 + Celecoxib + Cisplatin + Radiation Therapy (RT)
100 mg by mouth (PO) twice daily for 5 days before beginning radiation therapy; continued 7 days per week throughout radiation treatment (about 7 weeks).
Other Names:Drug: Cisplatin
25 mg/m^2 IV over 60 minutes on Day 1, Weeks 2-8
Other Names:Drug: CPT-11
30 mg/m^2 IV over 90 minutes on Day 1, Weeks 2-8, followed by cisplatin which will be infused for 60 minutes.
Other Name: IrinotecanRadiation: Concurrent Thoracic Radiation Therapy
63 Gy at 1.8 Gy/Fx in 35 Fractions over 7 weeks starting 2nd week of celebrex.
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 radiation therapy.
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 cisplatin.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00346801
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ritsuko R Komaki, MD||M.D. Anderson Cancer Center|