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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
- 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
- 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)
- Creatinine < 1.5 X upper limit of normal (ULN)
- 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.
- FEV1 ≥ 1 liter by spirometry within 60 days prior to registration for initial therapy.
Allocation: Non-Randomized, Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-Small Cell Lung Cancer
Cisplatin, Etoposide, Radiotherapy, Sorafenib
Medical & Surgical Specialists, LLC
Hoosier Oncology Group
Published on BioPortfolio: 2014-08-27T03:40:53-0400
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