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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

Phase 1/Phase 2
Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

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.

Inclusion Criteria:

1. Patients must have histologic evidence of NSCLC. Patients with bronchoalveolar type
of NSCLCA are not eligible.

2. Should a second malignancy be present or discovered, subjects will only be eligible
if the NSCLCA is determined by the PI to be the more life-threatening disease
compared to the other malignancy in regards of life-expectancy.

3. All patients must have locally advanced disease (stage III A or III B) or metastatic
(stage 4). Other stages are not eligible.

4. Performance status of 0 –1 (ECOG Criteria).

5. Patients should have an absolute granulocyte count > 1000/mm3 and a platelet count >

6. Patients should have adequate hepatic function as indicated by a serum bilirubin <
upper limit of normal (ULN); ALT and AST <2.5 ULN if alkaline phosphatase is < ULN.
Alkaline phosphatase may be up to 4 x ULN if transaminases are < ULN. However,
patients who have both transaminase elevation > 2 x ULN and alkaline phosphatase >
2.5 x ULN are not eligible for this study.

7. Subjects with with severe renal impairment (creatinine clearance below 30 mL/min
[Cockroft and Gault]) are ineligible.

8. Patients should have at least a predicted FEV1 of 30%.

9. Patients with active ischemic heart disease (NYHA Class III or IV), congestive heart
failure, symptomatic arrythmias, or a recent history of a myocardial infarction are

10. Patients with medically uncontrollable hypercoagalbility syndromes are not eligible.
Patients who are on therapeutic anticoagulation are not excluded.

11. Patients with pre-existing serious adverse effects to 5-FU are not eligible for this
study. Specifically, subjects with prior unanticipated severe reaction to
fluoropyrimidine therapy or known hypersensitivity to 5–fluorouracil.

12. Patients with medical contraindications to Taxanes are not eligible.

13. No other serious concurrent medical illness or active infection which would
jeopardize the ability of the patient to receive with reasonable safety the
chemotherapy and surgery program outlined in this protocol is allowed.

14. Subjects where studies or clinical examination demonstrates lack of physical
integrity of the upper gastrointestinal tract, inability to swallow tablets or those
who have malabsorption syndrome are not eligible.

15. Subjects who have had an organ allograft are not eligible.

16. Signed informed consent: each patient must be aware of the neoplastic nature of
his/her disease and willingly consent after being informed of the procedure to be
followed, the experimental nature of the therapy, alternatives, potential benefits,
side effects, risks, and discomforts.

17. Pregnant women and nursing mothers are ineligible. Eligible patients of reproductive
age should use contraception. Woman of childbearing potential with either a positive
or no pregnancy test at baseline. Woman of childbearing potential not using a
reliable and appropriate contraceptive method. (Postmenopausal women must have been
amenorrheic for at least 12 months to be considered of non–childbearing potential).

18. Sexually active males unwilling to practice contraception during the study will not
be eligible.

19. Patients must be at least 18 years old.

20. Known HIV positive patients will not be eligible.

21. Patients with prior treatment of Taxotere, Xeloda or 5FU will not be eligible.

Type of Study:


Study Design:

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

Outcome Measure:


Principal Investigator

Paul Schwarzenberger, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:



United States: Institutional Review Board

Study ID:

Hypo 2



Start Date:

September 2005

Completion Date:

October 2005

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • Hypofractionated Chest Radiation
  • Taxotere
  • 5-FU
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Mobile Infirmary Medical Center Mobile, Alabama  36640-0460
Providence Hospital, Mobile, Alabama  36685