Phase II Study of Weekly Docetaxel Together With Weekly Cisplatin in Chemotherapy-Naive Patients With Stage IV or Select Stage IIIB (Malignant Effusion) Non-Small Cell Lung Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS:

- Histologically or cytologically confirmed non-small cell lung cancer, meeting 1 of
the following stage criteria:

- Stage IIIB disease with malignant pericardial or malignant pleural effusions, as
indicated by 1 of the following:

- Positive cytology

- Exudative effusion AND lactic dehydrogenase (LDH) > 200 IU with
effusion/serum LDH ratio ≥ 0.6

- Stage IV disease

- Measurable disease, defined as ≥ 1 unidimensionally measurable lesion > 20 mm by
conventional techniques OR > 10 mm by spiral CT scan

- Brain metastases allowed provided they have been irradiated AND are radiographically
stable for ≥ 28 days after the completion of radiotherapy

PATIENT CHARACTERISTICS:

Age

- 18 and over

Performance status

- ECOG 0-1

Life expectancy

- At least 12 weeks

Hematopoietic

- Absolute neutrophil count ≥ 1,500/mm^3

- Platelet count ≥ 100,000/mm^3

- Hemoglobin ≥ 8.0 g/dL

Hepatic

- AST and ALT normal

- Bilirubin normal

Renal

- Creatinine clearance ≥ 50 mL/min

Immunologic

- No known HIV positivity

- No history of severe hypersensitivity reaction to docetaxel or other drugs formulated
with polysorbate 80

- No clinically significant active infection

Other

- Not pregnant or nursing

- Fertile patients must use effective contraception before, during, and for 4 weeks
after completion of study treatment

- No other primary malignancy within the past 5 years except adequately treated
nonmelanoma skin cancer or carcinoma in situ of the cervix

- No other serious systemic disorder that would preclude study participation

- No other condition that would preclude study compliance

PRIOR CONCURRENT THERAPY:

Biologic therapy

- Prior antibody-based therapy that targets growth factor pathways (e.g., epidermal
growth factor receptor [EGFR]) allowed provided there is disease progression during
therapy and patient has recovered

- No concurrent immunotherapy

- No concurrent prophylactic colony-stimulating factors

- No concurrent interleukin-11

Chemotherapy

- No prior cytotoxic chemotherapy

- No other concurrent chemotherapy

Endocrine therapy

- No concurrent hormonal therapy for the malignancy

Radiotherapy

- See Disease Characteristics

- More than 28 days since prior radiotherapy and recovered

- No prior radiotherapy to ≥ 25% of the bone marrow

- No prior radiotherapy to sites of measurable disease unless there is documented tumor
progression after completion of radiotherapy

- No concurrent radiotherapy

Surgery

- No concurrent surgery for the malignancy

Other

- More than 3 weeks since prior investigational drugs

- Prior oral small molecule drug therapy that targets growth factor pathways (e.g.,
EGFR) allowed provided there is disease progression during therapy and patient has
recovered

- No other concurrent investigational or commercial agents or therapies for the
malignancy