Hypo-Hyperfractionated Chest Radiation for Non Small Cell Lung Cancer With Taxotere/Xeloda Combination Chemotherapy

Carcinoma, Non-Small-Cell Lung Clinical Trial

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 I/II Study

Status Withdrawn

Clinical Trial 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.

Clinical Trial 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 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 Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung

• NCT number: NCT00256841
• Study type: Interventional
• Source: Clinical Oncology Research Associates
• Status: Withdrawn
• Phase: Phase 1/Phase 2
• Start date: September 2005
• Completion date: October 2007