Combination Chemotherapy, Surgery, and Radiation Therapy in Treating Patients With Non-Small Cell Lung Cancer

OBJECTIVES:

- Determine the complete resection rate and toxic death rate of patients with locally
advanced non-small cell lung cancer treated with paclitaxel, carboplatin, and
radiotherapy followed by surgical resection and adjuvant paclitaxel and carboplatin.

- Determine the survival, event-free survival, and incidence of pathologic complete
remission of patients treated with this regimen.

- Determine the protocol completion rate (CR) of patients treated with this regimen.

- Determine the feasibility and toxicity of this regimen in these patients.

- Determine the pathologic response rate/downstaging, pathologic near CR rate, freedom
from distant metastasis rate, and freedom from local regional failure rate of patients
treated with this regimen.

OUTLINE: Patients receive induction therapy comprising radiotherapy 5 days a week for 5.5-6
weeks and paclitaxel IV over 1 hour and carboplatin IV over 30 minutes on days 1, 8, 15, 22,
29, and 36.

Within 1-3 weeks after completion of induction therapy, patients undergo restaging. Patients
with resectable disease undergo surgical resection within 4-8 weeks after induction therapy.
Patients with unresectable disease undergo additional radiotherapy 5 days a week for 3 weeks
and receive paclitaxel and carboplatin as in induction therapy on days 1, 8, and 15.

Within 4-12 weeks after surgery or additional chemoradiotherapy, patients receive adjuvant
therapy comprising paclitaxel and carboplatin as in induction therapy on day 1. Adjuvant
treatment repeats every 4 weeks for 3 courses.

Patients are followed every 3 months for 2 years, every 6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Approximately 57 patients will be accrued for this study within 4 years.

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed, newly diagnosed, unilateral primary
non-small cell lung cancer (NSCLC)

- Must have involvement of the superior sulcus, chest wall, or mediastinum

- Must have at least 1 of the following:

- Locally advanced Pancoast tumors with no documented mediastinal or
supraclavicular nodal involvement (T3-T4, N0-1)

- Resectable chest wall disease (T3, N0-1)

- Marginally resectable T4, N0-1, or NX central NSCLC

- N2 patients who are potentially resectable after induction chemoradiotherapy

- No evidence of extrathoracic spread to liver, adrenals, brain, or bone

- No evidence of supraclavicular nodes, malignant pleural or pericardial effusions, or
distant metastases

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- Karnofsky 70-100%

Life expectancy

- Not specified

Hematopoietic

- Absolute neutrophil count at least 2,000/mm^3

- Platelet count at least 100,000/mm^3

Hepatic

- Bilirubin no greater than 1.5 mg/dL

- SGOT no greater than 3 times upper limit of normal

Renal

- Creatinine no greater than 2.0 mg/dL

Cardiovascular

- No superior vena cava syndrome

- No myocardial infarction within the past 6 months

- No active uncontrolled congestive heart failure

- No active uncontrolled arrhythmia within the past 6 months

Pulmonary

- FEV1 at least 800 mL

Other

- No other active invasive malignancy requiring therapy within the past 2 years

- No ongoing need for adjuvant therapy

- Not pregnant or nursing

- Negative pregnancy test

- Fertile patients must use effective contraception during and for at least 3 months
after study entry

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Not specified

Chemotherapy

- Not specified

Endocrine therapy

- Not specified

Radiotherapy

- No prior pelvic or thoracic radiotherapy

Surgery

- See Disease Characteristics

Other

- Concurrent beta blockers, digitalis derivatives, or channel-blocking agents allowed
provided cardiac conditions are stable