Carboplatin, Irinotecan, and Radiation Therapy Followed By Docetaxel in Treating Patients With Newly Diagnosed Stage III Non-Small Cell Lung Cancer

OBJECTIVES:

Primary

• Determine the objective response rate in patients with newly diagnosed stage IIIA or IIIB non-small cell lung cancer treated with concurrent carboplatin, irinotecan hydrochloride, and radiotherapy followed by consolidation docetaxel.

Secondary

• Evaluate the safety, toxicity, and complications of this regimen in these patients.
• Evaluate the median survival, 1-year and 2-year survival, and time to tumor progression in these patients.

OUTLINE:

• Chemoradiotherapy: Patients receive carboplatin IV over 30 minutes followed by irinotecan hydrochloride IV over 90 minutes on day 1. Patients also undergo radiotherapy once daily on days 1-5. Treatment repeats weekly for up to 7 courses in the absence of disease progression or unacceptable toxicity.
• Consolidation chemotherapy: Beginning 3-4 weeks after completion of chemoradiotherapy, patients receive docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for up to 3 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for 4 years and then annually thereafter.

PROJECTED ACCRUAL: A total of 32 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed non-small cell lung cancer (NSCLC)

• Stage IIIA or IIIB disease
• Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by conventional techniques or > 10 mm by spiral CT scan
• No clinically significant malignant pleural or pericardial effusion (i.e., stage IIIB wet disease)

PATIENT CHARACTERISTICS:

• ECOG performance status 0-1
• Absolute neutrophil count > 1,500/mm³
• Platelet count > 100,000/mm³
• Hemoglobin ≥ 8.0 g/dL
• Bilirubin normal
• Alkaline phosphatase (AP), AST, and ALT meeting 1 of the following criteria:

• AP normal AND AST or ALT ≤ 5 times upper limit of normal (ULN)
• AP ≤ 2.5 times ULN AND AST or ALT ≤ 1.5 times ULN
• AP ≤ 5 times ULN AND AST or ALT normal
• Creatinine < 2.0 times ULN
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for ≥ 3 months after completion of study treatment
• No New York Heart Association class III-IV heart disease
• No history of serious cardiac disease not adequately controlled
• No documented myocardial infarction within the past 6 months
• No congestive heart failure
• No unstable angina
• No clinically significant arrhythmia
• No history of severe hypersensitivity reaction to drugs formulated with polysorbate 80
• No peripheral neuropathy > grade 1
• No other malignancy within the past 5 years other than skin cancer

PRIOR CONCURRENT THERAPY:

• More than 3 weeks since prior major surgery
• No prior systemic chemotherapy, thoracic radiotherapy, or surgical resection for NSCLC