NCT00417248

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

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

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 8 (actual)
• Sponsor: Nasser Hanna, M.D. · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Non-Small Cell Lung Cancer

Interventions

Type	Name	Description
DRUG	Cisplatin	Cisplatin 50 mg/m2 IV, days 1 and 8 of 28 day cycle
DRUG	Etoposide	Etoposide 50 mg/m2 IV, days 1-5 of 28 day cycle
PROCEDURE	Radiotherapy	Concurrent chest radiation (planned dose is 5940 cGy with an additional, optional boost of 1080 cGy to a total allowed dose of 7020 cGy)
DRUG	Sorafenib	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

Timeline

• Start date: 2007-06-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2006-12-29
• Last updated: 2016-07-25
• Results posted: 2016-07-25

Locations

8 sites across 1 country: United States