Cisplatin/Etoposide/Radiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer

2014-08-27 03:40:53 | BioPortfolio


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.

Study Design

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
United States




Hoosier Oncology Group

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:40:53-0400

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Medical and Biotech [MESH] Definitions

Malignant neoplasm arising from the epithelium of the BRONCHI. It represents a large group of epithelial lung malignancies which can be divided into two clinical groups: SMALL CELL LUNG CANCER and NON-SMALL-CELL LUNG CARCINOMA.

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