Docetaxel and Cisplatin in Treating Patients With Stage I, Stage II, or Stage III Non-Small Cell Lung Cancer That Has Been Completely Removed By Surgery

OBJECTIVES:

Primary

• Compare the efficacy and safety of a new dosing schedule and dosing level of docetaxel and cisplatin with the chemotherapy regimens used in the International Adjuvant Lung Cancer Trial (IALT) in patients with completely resected stage IA-IIIB non-small cell lung cancer.

Secondary

• Explore the relationship of time to recurrence, disease-free survival, and overall survival of these patients with levels of circulating DNA and proteomic analysis of serum.

OUTLINE: This is an open-label study.

Patients receive docetaxel IV over 30 minutes on days 1, 8, and 15 and cisplatin IV over 8 hours on day 15. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

PROJECTED ACCRUAL: A total of 50 patients will be accrued for this study.

DISEASE CHARACTERISTICS:

• Pathologically proven non-small cell lung cancer (NSCLC)

• Stage IA-IIIB disease
• Underwent prior complete surgical resection (R0) no more than 2 months ago
• Eligible for cisplatin-based adjuvant chemotherapy

PATIENT CHARACTERISTICS:

• Karnofsky performance status ≥ 70%
• Absolute neutrophil count ≥ 1,500/mm^3
• Hemoglobin ≥ 8.0 g/dL
• Platelet count ≥ 100,000/mm^3
• Creatinine clearance > 55 mL/min
• Total bilirubin normal
• Alkaline phosphatase, AST, and ALT must meet 1 of the following criteria:

• Alkaline phosphatase (AP) normal AND AST and ALT ≤ 5 times upper limit of normal (ULN)
• AP ≤ 2.5 times ULN AND AST and ALT ≤ 1.5 times ULN
• AP ≤ 5 times ULN AND AST and ALT normal
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 3 months after completion of study treatment
• No history of severe hypersensitivity reaction to docetaxel or other drugs formulated with polysorbate 80
• No peripheral neuropathy > grade 1
• No hearing deficit at baseline, even if it does not require a hearing aid or intervention or interfere with activities of daily life (i.e., CTCAE grade 2 or higher)

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• No prior postoperative radiation therapy
• No prior chemotherapy for NSCLC
• No prior docetaxel or cisplatin
• No concurrent prophylactic filgrastim (G-CSF) or pegfilgrastim