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

About this trial
This is an interventional treatment trial for Lung Cancer focused on measuring recurrent non-small cell lung cancer, stage IIIB non-small cell lung cancer, stage IV non-small cell lung cancer
Eligibility 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
Sites / Locations
- Sydney Heamatology and Oncology Clinics
- Institute of Oncology at Prince of Wales Hospital
- Royal North Shore Hospital
- Sydney Cancer Centre at Royal Prince Alfred Hospital
- Newcastle Mater Misericordiae Hospital
- Princess Alexandra Hospital
- Prince Charles Hospital
- Nambour General Hospital
- Mater Medical Centre
- Queen Elizabeth Hospital
- Alfred Hospital
- Murray Valley Private Hospital and Cancer Treatment Centre
- Sir Charles Gairdner Hospital - Perth
Arms of the Study
Arm 1
Arm 2
Active Comparator
Experimental
docetaxel
PI-88+docetaxel
treated with docetaxel alone
treated with docetaxel and PI-88