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

Non-Small Cell Lung Cancer Clinical Trial

Official title: 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

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma, Non-Small-Cell Lung
• Lung Neoplasms
• Non-Small Cell Lung Cancer

• NCT number: NCT00417248
• Study type: Interventional
• Source: Hoosier Cancer Research Network
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: June 2007
• Completion date: April 2008