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Brief Title: Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer
Official Title: A Phase II Trial of Concurrent Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer (NSCLC): Hoosier Oncology Group LUN06-107
Study ID: NCT00417248
Brief Summary: Sorafenib has demonstrated in vivo anti-tumor efficacy. This trial will evaluate the safety and preliminary efficacy of sorafenib following chemoradiation in locally advanced NSCLC.
Detailed Description: Outline: This is a multi-center study. Chemotherapy/radiation therapy (2 cycles) * Cisplatin 50 mg/m2 IV days 1 and 8 of 28 day cycle * Etoposide 50 mg/m2 IV days 1-5 of 28 day cycle * Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy) with the following: Maintenance therapy of Sorafenib 400 mg PO BID of 28 day cycle, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 1 year. Patients with progressive disease will discontinue treatment. ECOG performance status 0 or 1 Hematopoietic: * Absolute neutrophil count (ANC) ≥ 1500 mm3 * Platelet count ≥ 100,000 mm3 * Hemoglobin ≥ 9 g/dL * PT or INR \< 1.5 x ULN unless on anti-coagulant therapy * PTT \< 1.5 x ULN unless on anti-coagulant therapy Hepatic: * Bilirubin ≤ 1.5 x ULN * ALT ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) * AST ≤ 2.5 x ULN (≤ 5 x ULN for patients with liver involvement) Renal: * Creatinine \< 1.5 X upper limit of normal (ULN) Cardiovascular: * No significant history of cardiac disease: Congestive heart failure \> class II NYHA. * Patients must not have unstable angina (anginal symptoms at rest) or new onset angina (began within 90 days prior to registration for initial therapy) or myocardial infarction within 6 months prior to registration for initial therapy. Respiratory: * FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Medical & Surgical Specialists, LLC, Galesburg, Illinois, United States
Fort Wayne Oncology & Hematology, Inc, Fort Wayne, Indiana, United States
Center for Cancer Care at Goshen Health System, Goshen, Indiana, United States
Indiana University Cancer Center, Indianapolis, Indiana, United States
Horizon Oncology Center, Lafayette, Indiana, United States
Medical Consultants, P.C., Muncie, Indiana, United States
Northern Indiana Cancer Research Consortium, South Bend, Indiana, United States
Oncology Partners Network, Cincinnati, Ohio, United States
Name: Nasser Hanna, M.D.
Affiliation: Hoosier Oncology Group, LLC
Role: STUDY_CHAIR