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Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer: A Feasibility Study

Open (Enrolling)
Carcinoma, Non-Small-Cell Lung

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Trial Information

Combination of Weekly Radiation and Docetaxel for Locally Advanced Non Small Cell Lung Cancer: A Feasibility Study

40 patients with locally advanced and metastatic NSCLC will be enrolled (stages III and IV)
and treated once per week for a total of 12 cycles (12 weeks) according to the schedule
outlined below.

Chemotherapy: The suggested phase II dose for weekly Taxotere with concomitant standard
chest radiotherapy was determined to be 20mg/m2. In our unpublished phase I clinical trial,
we found 35 mg/m2 to be well tolerated and therefore this dose is chosen for this phase II
study. The drug will be administered intravenously on the same day as the radiation. All
patients will be premedicated 12 hours prior to chemotherapy with Decadrone. Patients will
be followed and evaluated weekly by a physician.

Radiation therapy: Although radiation was delivered differently in previous Taxotere based
combined modality studies, the total radiation dose remains the same. 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. To reduce volume toxicity, the “field within a field” technique
will be employed. Tumor and involved nodes will receive 200 cGy + 300 cGy. A total of 12
treatments will be administered in weekly, single sessions. Total treatment will be 6000
cGy. Radiation treatment will be administered 24 hours after Taxotere infusion.

Inclusion Criteria:

1. Patients must have histologic evidence of NSCLC.

2. Should the patient have a history of another malignancy or a second malignancy be
present or discovered, subjects will only be eligible if the NSCLC is determined by
the PI to be the more life-threatening disease and the other malignancy would not
have otherwise a significant impact on the subjects life-expectancy (e.g. basal cell
carcinoma of skin, remote history of early stage breast cancer surgically cured).

3. All patients must have surgically incurable disease, i.e. locally advanced disease
(stage III A or III B) or metastatic stage IV.

4. Performance status of 0 to 2 (ECOG Criteria).

5. Patients should have an absolute granulocyte count > 1500/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 > 1.5 x ULN and alkaline phosphatase >
2.5 x ULN are not eligible for this study.

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

8. 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

9. Patients with pre-existing neuropathy (> grade 1) are not eligible for this study.

10. 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.

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

12. Pregnant women and nursing mothers are ineligible. Women of child-bearing potential
must have a negative pregnancy test. Women of childbearing potential must be willing
to consent to using effective contraception while on treatment and for three months

13. Patients with a history of severe hypersensitivity reaction to TaxotereÒ or other
drugs formulated with polysorbate 80 must be excluded.

14. Patients must be at least 18 years old.


Exclusion Criteria:

Not falling into the eligibility criteria outlined above

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:

Mobile Infirmary Hospital, Mobile, AL


United States: Institutional Review Board

Study ID:

Hypo 1



Start Date:

September 2002

Completion Date:

November 2007

Related Keywords:

  • Carcinoma, Non-Small-Cell Lung
  • NSCLC, Non-Small Cell Lung Cancer,Weekly Radiation, Taxotere
  • Carcinoma
  • Carcinoma, Non-Small-Cell Lung
  • Lung Neoplasms



Cancer Center and Mobile Infirmary Hospital Mobile, Alabama  36607