Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00256841
Status:
WITHDRAWN
Last Update Posted:
2014-01-29
First Post:
2005-11-21
Brief Title:
Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With TaxotereXeloda Combination Chemotherapy
Sponsor:
Clinical Oncology Research Associates
Organization:
Clinical Oncology Research Associates
Study Overview
Official Title:
Dose Escalation of Xeloda or 5FU Continuous Infusion in Combination With Taxotere and Concurrent Once Weekly Hypofractionated Chest Radiotherapy for Advanced Non Small Cell Lung Cancer A Phase III Study
Status:
WITHDRAWN
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Lack of funding
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study is designed for patients with non small cell lung cancer whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer At this stage of the disease most patients cannot be cured from the disease however treatment can help to live longer and better by keeping the cancer under control For that purpose patients traditionally receive radiation therapy or chemotherapy or both treatments in succession Recently the administration of both treatment methods given concurrently showed somewhat better results when compared to successive administration In some studies the drug Taxotere together with radiation performed well in keeping the cancer better under control
Combination of the drug Taxotere together with a compound called 5-FU either as continuous infusion or in its oral form of a pill called Xeloda enhanced its anti cancer activity substantially
One goal of this study is to investigate how much of the combination can be given in conjunction with chest radiation Using X-rays the study will also evaluate how much shrinkage of the cancer is caused by this treatment directly at the tumor site and other areas where the cancer may have also spread
In this study the radiation will be given on only one day per week in two sessions rather than divided over five days per week Monday through Friday as it is more commonly used However both schedules have been found to be equally effective
The treatment program will use increasing doses of the 5-FU medication either as infusion or as pill to find the highest dose that is tolerated Once the highest tolerated dose is determined subsequent patients who will be enrolled will continue to be treated at that dose level The dose of the drug Taxotere will remain the same throughout
Hypothesis Our previous research suggests that the combination of Taxotere and 5-FU given together with weekly chest radiation will provide a more convenient form of treatment than the conventional approach and also be at least similar in its efficacy
Combination of the drug Taxotere together with a compound called 5-FU either as continuous infusion or in its oral form of a pill called Xeloda enhanced its anti cancer activity substantially
One goal of this study is to investigate how much of the combination can be given in conjunction with chest radiation Using X-rays the study will also evaluate how much shrinkage of the cancer is caused by this treatment directly at the tumor site and other areas where the cancer may have also spread
In this study the radiation will be given on only one day per week in two sessions rather than divided over five days per week Monday through Friday as it is more commonly used However both schedules have been found to be equally effective
The treatment program will use increasing doses of the 5-FU medication either as infusion or as pill to find the highest dose that is tolerated Once the highest tolerated dose is determined subsequent patients who will be enrolled will continue to be treated at that dose level The dose of the drug Taxotere will remain the same throughout
Hypothesis Our previous research suggests that the combination of Taxotere and 5-FU given together with weekly chest radiation will provide a more convenient form of treatment than the conventional approach and also be at least similar in its efficacy
Detailed Description:
The original once weekly hypofractionated chest irradiation protocol descrived by Salazar et al will be followed with a slight modification The dose will be split in two fractions which will be given 6 hours apart We found that this fractionation in two doses reduces radiation-related side effects Treatment will be given to a large field with a 2-3 cm tumor margin All involved or suspicious nodal areas will be radiated as well A total of 12 treatments will be administered in weekly Total treatment will be 6000 cGy Radiation treatment will be administered within 2 hours of Taxotere infusion
All patients will receive a fixed dose of Taxotere of 25 mgm2 once per week on the day of radiotherapy preceeding the radiation All patients will be premedicated using standard antiemetics and Decadron 8 mg po 12 hours prior Taxotere 1 mg Kytril po 20 mg Decadron iv 50 mg Benadryl iv and 20 mg Pepcid iv all 30 min prior Taxotere
A dose escalation of 5-FU or Xeloda will be employed 5-FU will be given as continuous infusion Xeloda orally Monday through Friday throughout the 12 weeks of radiation Upon reaching the maximum tolerated dose the remainder of patients will be treated at the 5-FUXeloda dose level below the MTD
Patients for who are unable to tolerate oral Xeloda because of the size of the tablets or difficulties with their upper gastroiontestinal tract or for whom Xeloda cannot be obtained the intravenous equivalent of 5-Fluorouracil 5-FU will be administered as a continuous intravenous infusion Patients who started out on Xeloda and during the treatment experience difficulties in continuing taking Xeloda maybe switched to a biological equivalent dose of 5-FU during the treatment The 5-FU dose range administered in lieu of Xeloda will be administered and adjustments will be made in 50 mgm2day steps as previously pubished by Lokich et al
All patients will receive a fixed dose of Taxotere of 25 mgm2 once per week on the day of radiotherapy preceeding the radiation All patients will be premedicated using standard antiemetics and Decadron 8 mg po 12 hours prior Taxotere 1 mg Kytril po 20 mg Decadron iv 50 mg Benadryl iv and 20 mg Pepcid iv all 30 min prior Taxotere
A dose escalation of 5-FU or Xeloda will be employed 5-FU will be given as continuous infusion Xeloda orally Monday through Friday throughout the 12 weeks of radiation Upon reaching the maximum tolerated dose the remainder of patients will be treated at the 5-FUXeloda dose level below the MTD
Patients for who are unable to tolerate oral Xeloda because of the size of the tablets or difficulties with their upper gastroiontestinal tract or for whom Xeloda cannot be obtained the intravenous equivalent of 5-Fluorouracil 5-FU will be administered as a continuous intravenous infusion Patients who started out on Xeloda and during the treatment experience difficulties in continuing taking Xeloda maybe switched to a biological equivalent dose of 5-FU during the treatment The 5-FU dose range administered in lieu of Xeloda will be administered and adjustments will be made in 50 mgm2day steps as previously pubished by Lokich et al
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