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 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.
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Paul Schwarzenberger, MD
United States: Institutional Review Board
|Mobile Infirmary Medical Center||Mobile, Alabama 36640-0460|
|Providence Hospital,||Mobile, Alabama 36685|