Paclitaxel and Carboplatin With or Without BMS-275291 in Treating Patients With Advanced or Metastatic Non-small Cell Lung Cancer

DISEASE CHARACTERISTICS:

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

  • Local or metastatic failure after surgery and/or radiotherapy allowed

• Phase II only:

  • At least one measurable lesion

    • At least 20 mm by conventional techniques OR 10 mm by spiral CT scan
• No known CNS metastases unless asymptomatic and at least 4 weeks since prior corticosteroid therapy

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Performance status:

• ECOG 0-2

Life expectancy:

• At least 12 weeks

Hematopoietic:

• Absolute granulocyte count at least 1,500/mm^3
• Platelet count at least 100,000/mm^3

Hepatic:

• Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• ALT no greater than 2 times ULN (5 times ULN for liver metastases)

Renal:

• Creatinine no greater than 1.5 times ULN

Cardiovascular:

• No significant cardiac disease
• No uncontrolled high blood pressure, unstable angina, congestive heart failure, second or third degree atrioventricular conduction defects, or ventricular arrhythmias requiring medication
• No myocardial infarction within the past year

Other:

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• No prior allergic reaction to drugs containing Cremophor EL
• No serious active infection or other underlying medical condition that would preclude study participation
• No peripheral neuropathy
• No condition (e.g., psychological, geographical) that would preclude study participation
• No prior breast cancer or melanoma
• No other prior malignancy within the past 5 years except carcinoma in situ, basal cell or squamous cell skin cancer, or other cancer that has been curatively treated surgically

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• No prior immunotherapy
• No prior biological response modifiers
• No other concurrent biologic therapy or immunotherapy

Chemotherapy:

• No prior antineoplastic chemotherapy, including intrapleural chemotherapy

Endocrine therapy:

• See Disease Characteristics

Radiotherapy:

• See Disease Characteristics
• No prior radiotherapy to study lesion (unless evidence of disease progression) or to 30% or greater of marrow bearing bones
• At least 1 week since prior radiotherapy and recovered
• No concurrent radiotherapy

Surgery:

• See Disease Characteristics
• At least 2 weeks since prior major surgery
• No concurrent surgery

Other:

• At least 2 weeks since prior investigational drugs
• No other concurrent cytotoxic anticancer therapy
• No other investigational drugs during and for 30 days after study