Sorafenib in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer
Recurrent Non-small Cell Lung Cancer, Stage IIIB Non-small Cell Lung Cancer, Stage IV Non-small Cell Lung Cancer

About this trial
This is an interventional treatment trial for Recurrent Non-small Cell Lung Cancer
Eligibility Criteria
Inclusion Criteria: Histologically or cytologically confirmed non-small cell lung cancer (NSCLC), meeting 1 of the following stage criteria: Stage IIIB with pleural effusion Stage IV Measurable disease At least 1 lesion ≥ 2.0 cm by conventional techniques OR ≥ 1.0 cm by spiral CT scan The following are not considered measurable disease: Bone lesions Leptomeningeal disease Ascites Pleural/pericardial effusion Inflammatory breast disease Lymphangitis cutis/pulmonis Abdominal masses not confirmed and followed by imaging techniques Cystic lesions No known brain metastases, even if treated and stable Performance status - ECOG 0-2 At least 12 weeks Absolute neutrophil count ≥ 1,500/mm^3 Platelet count ≥ 100,000/mm^3 Hemoglobin ≥ 10 g/dL No bleeding diathesis Bilirubin ≤ 2 times upper limit of normal (ULN) AST ≤ 3 times ULN (5 times ULN if hepatic metastasis present) Creatinine ≤ 1.5 times ULN No uncontrolled hypertension Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception No known HIV positivity HIV negative Able to swallow tablets No uncontrolled infection No other severe underlying disease that would preclude study participation No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer or adequately treated noninvasive carcinomas No prior immunotherapy, biologic therapy, or gene therapy No concurrent prophylactic colony-stimulating factors At least 4 weeks since prior low-dose weekly chemotherapy as a radiosensitizer No other prior chemotherapy for NSCLC No concurrent chemotherapy See Chemotherapy At least 4 weeks since prior radiotherapy No prior radiotherapy to ≥ 30% of bone marrow No concurrent radiotherapy Concurrent palliative radiotherapy to nontarget lesions (e.g., painful pre-existing bony metastasis) allowed Prior adjuvant therapy allowed provided recurrent disease occurred > 6 months after completion of adjuvant therapy No prior systemic therapy for NSCLC, including all novel targeted agents (e.g., gefitinib or erlotinib) No concurrent therapeutic anticoagulation Prophylactic anticoagulation (e.g., low-dose warfarin) for venous and arterial devices allowed provided PT, INR, and PTT requirements are met No other concurrent anticancer agents or therapies No other concurrent investigational agents or therapies
Sites / Locations
- North Central Cancer Treatment Group
Arms of the Study
Arm 1
Experimental
Treatment (sorafenib tosylate)
Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.