Clinical trial NCT00098540 (phase 2, status: completed)
Conditions: recurrent non-small cell lung cancer, stage iiib non-small cell lung cancer, stage iv non-small cell lung cancer
ICD codes: C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2, C78.00, C78.01, C78.02, D14.30, D14.31, D14.32, C34.2
Drugs: sorafenib tosylate
SMILES: CNC(=O)C1=NC=CC(OC2=CC=C(NC(=O)NC3=CC(=C(Cl)C=C3)C(F)(F)F)C=C2)=C1
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