Ignite Creation Date:
2024-05-05 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00346801
Status:
COMPLETED
Last Update Posted:
2012-10-22
First Post:
2006-06-28
Brief Title:
CPT-11Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer NSCLC
Sponsor:
MD Anderson Cancer Center
Organization:
MD Anderson Cancer Center
Study Overview
Official Title:
A Phase I Study of Concurrent CPT-11Cisplatin and Celecoxib With Radiation Therapy for Patients With Unresectable Non-Small Cell Lung Cancer NSCLC
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Primary Objectives
To determine the feasibility activity and toxicity of a novel regimen using a concurrent irinotecan CPT-11cisplatin and celecoxib combination for patients with unresectable NSCLC
To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecancisplatin 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
To determine the feasibility activity and toxicity of a novel regimen using a concurrent irinotecan CPT-11cisplatin and celecoxib combination for patients with unresectable NSCLC
To determine the maximal tolerance dose of celecoxib in patients with unresectable NSCLC treated with irinotecancisplatin 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
Detailed Description:
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 CTMRI scans andor 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
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 CTMRI scans andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None