Vinorelbine, Gemcitabine, and Docetaxel Compared With Paclitaxel and Carboplatin in Treating Patients With Advanced Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed primary non-small cell lung cancer (NSCLC) meeting criteria for 1 of the following:

  • Newly diagnosed selected stage IIIB (T4 lesion due to malignant pleural effusion) disease
  • Newly diagnosed stage IV disease
  • Recurrent disease after prior surgery and/or radiotherapy

• The following cellular subtypes are allowed:

  • Adenocarcinoma
  • Large cell carcinoma
  • Squamous cell carcinoma
  • Unspecified carcinoma

• Measurable or nonmeasurable disease by CT scan, MRI, x-ray, physical examination, or bone scintigraphy

  • Pleural effusions, ascites, and laboratory parameters are not allowed as the only evidence of disease
  • Disease must be present outside area of prior surgical resection
  • Disease must be present outside area of prior radiotherapy OR new lesion documented
• No known brain metastases by CT scan or MRI within the past 6 weeks
• No pleural or pericardial effusions requiring treatment

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• Zubrod 0-1

Life expectancy

• Not specified

Hematopoietic

• Absolute granulocyte count ≥ 1,500/mm^3
• Platelet count ≥ 100,000/mm^3
• Hemoglobin ≥ 9 g/dL

Hepatic

• Bilirubin ≤ 2 times upper limit of normal (ULN)
• SGOT or SGPT ≤ 2 times ULN
• Alkaline phosphatase ≤ 2 times ULN

Renal

• Creatinine ≤ ULN
• Creatinine clearance ≥ 50 mL/min

Cardiovascular

• No uncontrolled hypertension
• No unstable angina
• No congestive heart failure
• No myocardial infarction within the past year
• No ventricular arrhythmia requiring medical intervention

Other

• Not pregnant or nursing
• Fertile patients must use effective contraception
• No prior allergic drug reaction attributed to Cremophor or polysorbate 80
• No disorder associated with lung cancer with life-threatening consequences
• No motor or sensory neuropathy ≥ grade 2
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or adequately treated stage I or II cancer currently in complete remission
• No uncontrolled diabetes

PRIOR CONCURRENT THERAPY:

Biologic therapy

• No prior biologic therapy for NSCLC

Chemotherapy

• No prior systemic chemotherapy for NSCLC

Endocrine therapy

• No prior or concurrent steroid-type hormonal therapy (e.g., ethinyl estradiol)

Radiotherapy

• See Disease Characteristics
• At least 3 weeks since prior radiotherapy and recovered

Surgery

• See Disease Characteristics
• At least 2 weeks since prior thoracic or other major surgery and recovered

Other

• No prior or concurrent azole antifungal therapy (e.g., ketoconazole, miconazole, or itraconazole)
• No prior or concurrent macrolides (e.g., erythromycin or clarithromycin)
• No prior or concurrent cyclosporine, terfenadine, benzodiazepines (e.g., diazepam, triazolam, or midazolam), or retinoids
• No prior or concurrent calcium antagonists (e.g., diltiazem, nifedipine, or verapamil)