Docetaxel With or Without PI-88 in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer

DISEASE CHARACTERISTICS:

• Diagnosis of non-small cell lung cancer

  • Stage IIIB or IV disease

• Eligible for second-line docetaxel

  • Disease progression during or after completion of prior first-line therapy comprising radiotherapy and/or platinum-based chemotherapy

PATIENT CHARACTERISTICS:

Age

• 18 and over

Performance status

• ECOG 0-1

Life expectancy

• At least 2 months

Hematopoietic

• Neutrophil count > 1,500/mm^3
• Platelet count > 100,000/mm^3
• WBC > 3,000/mm^3
• No history of thrombotic thrombocytopenic purpura or other platelet disease

Hepatic

• Bilirubin normal
• ALT and AST ≤ 2.5 times upper limit of normal (ULN) (1.5 times ULN if alkaline phosphatase > 2.5 times ULN)
• Alkaline phosphatase ≤ 5 times ULN (unless bone metastases are present)
• PT < 1.5 times ULN
• Activated PTT normal

Renal

• Creatinine clearance or glomerular filtration rate > 50mL/min

Cardiovascular

• None of the following within the past 3 months:

  • Myocardial infarction
  • Stroke
  • Congestive heart failure

Immunologic

• No history of immune-mediated thrombocytopenia
• No evidence of anti-heparin antibodies
• No history of allergy and/or hypersensitivity to anti-coagulants or thrombolytic agents, especially heparin
• No history of allergy to polysorbate 80
• No uncontrolled or serious infection within the past 4 weeks

Other

• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• See Disease Characteristics
• No prior docetaxel

Endocrine therapy

• Not specified

Radiotherapy

• See Disease Characteristics
• More than 3 months since prior radiotherapy to > 30% of marrow-bearing bone
• Concurrent local palliative radiotherapy allowed

Surgery

• More than 4 weeks since prior major surgery

Other

• More than 4 weeks since prior antineoplastic therapy
• More than 2 weeks since prior and no concurrent heparin or low-molecular weight heparin
• More than 4 weeks since prior investigational therapy
• No concurrent aspirin or aspirin-containing medications except low-dose aspirin (≤ 100 mg/day)
• No concurrent nonsteroidal anti-inflammatory drugs except cyclooxygenase-2 inhibitors
• No concurrent warfarin or warfarin-containing medications except low-dose warfarin (≤ 1 mg/day)

• No concurrent antiplatelet drugs, including any of the following:

  • Abciximab
  • Clopidogrel
  • Dipyridamole
  • Ticlopidine
  • Tirofiban

• No concurrent drugs that may inhibit docetaxel metabolism, including any of the following:

  • Cyclosporine
  • Terfenadine
  • Ketoconazole
  • Erythromycin
  • Troleandomycin
• No other concurrent investigational drugs
• No other concurrent antineoplastic therapy