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
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, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
The primary objective is to determine the time to disease progression
Nasser Hanna, M.D.
Hoosier Oncology Group, LLC
United States: Institutional Review Board
|Indiana University Cancer Center||Indianapolis, Indiana 46202-5265|
|Center for Cancer Care at Goshen Health System||Goshen, Indiana 46526|
|Oncology Partners Network||Cincinnati, Ohio 45238|
|Northern Indiana Cancer Research Consortium||South Bend, Indiana|
|Medical & Surgical Specialists, LLC||Galesburg, Illinois 61401|
|Horizon Oncology Center||Lafayette, Indiana 47905|
|Medical Consultants, P.C.||Muncie, Indiana 47303|
|Fort Wayne Oncology & Hematology, Inc||Fort Wayne, Indiana 46815|