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

Inclusion Criteria

• •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