Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00256841|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : November 22, 2005
Last Update Posted : January 29, 2014
|First Submitted Date ICMJE||November 21, 2005|
|First Posted Date ICMJE||November 22, 2005|
|Last Update Posted Date||January 29, 2014|
|Study Start Date ICMJE||September 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
|Original Primary Outcome Measures ICMJE||Same as current|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Pre-specified Outcome Measures||Not Provided|
|Original Other Pre-specified Outcome Measures||Not Provided|
|Brief Title ICMJE||Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy|
|Official Title ICMJE||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 I/II Study|
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.
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 mg/m2 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-FU/Xeloda 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 mg/m2/day steps as previously pubished by Lokich et al.
|Study Type ICMJE||Interventional|
|Study Phase ICMJE||Phase 1
|Study Design ICMJE||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Condition ICMJE||Carcinoma, Non-Small-Cell Lung|
|Study Arms ICMJE||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Withdrawn|
|Actual Enrollment ICMJE
|Original Enrollment ICMJE
|Actual Study Completion Date ICMJE||October 2007|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages ICMJE||Child, Adult, Older Adult|
|Accepts Healthy Volunteers ICMJE||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Listed Location Countries ICMJE||United States|
|Removed Location Countries|
|NCT Number ICMJE||NCT00256841|
|Other Study ID Numbers ICMJE||Hypo 2|
|Has Data Monitoring Committee||Not Provided|
|U.S. FDA-regulated Product||Not Provided|
|IPD Sharing Statement ICMJE||Not Provided|
|Responsible Party||Paul Schwarzenberger, MD, Clinical Oncology Research Associates|
|Study Sponsor ICMJE||Clinical Oncology Research Associates|
|Collaborators ICMJE||Not Provided|
|PRS Account||Clinical Oncology Research Associates|
|Verification Date||January 2014|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP