Phase II Trial of Pulsed Taxol With Concurrent Thoracic Radiotherapy, & Adjuvant Chemo in Stage III NSCLC

OBJECTIVES Primary

1. Overall survival

2. Tumor response using RECIST criteria

Secondary

1. Determine the toxicity of the proposed treatment in this patient population.

2. Progression free survival

3. Locoregional control

4. Distant failure

STUDY DESIGN

Description of the Study Phase II study to evaluate the toxicity and overall survival of
pulsed paclitaxel with concurrent thoracic radiotherapy, and adjuvant gemcitabine and
carboplatin in stage IIIA and IIIB non-small cell lung cancer.

Rationale for Study Design The proposed doses of gemcitabine, carboplatin, paclitaxel, and
thoracic radiation therapy have been previously studied and deemed safe. The design of this
study is not to find the maximum tolerated dose (MTD) of these agents, but to study the
toxicity and overall survival from this combination.

Outcome Measures Primary Outcome Measures

1. Overall survival

2. Tumor response using RECIST criteria

Secondary Outcome Measures

1. Locoregional control

2. Distant Failure

3. Progression free survival

Inclusion Criteria:

1. Patients must have: IIIA or IIIB non-small cell lung cancer by radiographic or
surgical staging, excluding: superior sulcus tumors, tumors with associated
atelectasis or obstructive pneumonitis of the entire lung, and tumors with a malignant
pleural effusion.

2. Patients will be included in the study based on the following criteria:

- Patients must be older than 18 years old.

- Patients must have a Zubrod performance status of 0 to 2

- Patients with adequate bone marrow function

- Patients with adequate renal function

- Patients with adequate hepatic function

- Patients of childbearing potential must have a negative serum pregnancy test and
use an effective form of contraception.

- Patients who are suitable for treatment with radical intent using concurrent
chemotherapy and radiation.

- Patients who have signed an approved informed consent and authorization
permitting release of personal health information.

Exclusion Criteria:

1. Disease-Specific Exclusions

- Superior sulcus tumors

- Atelectasis or obstructive pneumonitis of the entire lung

- Malignant pleural effusion

2. General Medical Exclusions

- Surgical candidates

- Patients who are pregnant at the time of diagnosis

- Serious concomitant systemic disorders incompatible with the study

- Inability to comply with study and/or follow-up procedures

- Life expectancy of less than 12 weeks

- Current, recent (within 4 weeks of the first infusion of this study), or planned
participation in an experimental drug study

- Patients with septicemia or severe infection.

- Patients who have circumstances that will not permit completion of this study or
the required follow-up

- Patients with any contraindication to gemcitabine, carboplatin, or paclitaxel