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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
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)
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
Time to Disease Progression (TTP)
Time frame: 18 months
Overall Survival
Time frame: 18 months
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Maintenance therapy of Sorafenib 400 mg PO BID, to begin a minimum of 6 and maximum of 9 weeks from completion of chemo-radiotherapy until PD, intolerable toxicity, or up to 6 months
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