Ignite Creation Date:
2024-05-05 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417248
Status:
TERMINATED
Last Update Posted:
2016-07-25
First Post:
2006-12-28
Brief Title:
CisplatinEtoposideRadiotherapy Followed by Consolidation Sorafenib for Inoperable Stage III Non-Small Cell Lung Cancer
Sponsor:
Nasser Hanna MD
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Trial of Concurrent CisplatinEtoposideRadiotherapy Followed by Consolidation Sorafenib in Patients With Inoperable Stage III Non-Small Cell Lung Cancer NSCLC Hoosier Oncology Group LUN06-107
Status:
TERMINATED
Status Verified Date:
2016-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Negative sorafenib results from ESCAPE trial and safety concerns of regimen
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Chemotherapyradiation therapy 2 cycles
Cisplatin 50 mgm2 IV days 1 and 8 of 28 day cycle
Etoposide 50 mgm2 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 100000 mm3
Hemoglobin 9 gdL
PT or INR 15 x ULN unless on anti-coagulant therapy
PTT 15 x ULN unless on anti-coagulant therapy
Hepatic
Bilirubin 15 x ULN
ALT 25 x ULN 5 x ULN for patients with liver involvement
AST 25 x ULN 5 x ULN for patients with liver involvement
Renal
Creatinine 15 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
Chemotherapyradiation therapy 2 cycles
Cisplatin 50 mgm2 IV days 1 and 8 of 28 day cycle
Etoposide 50 mgm2 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 100000 mm3
Hemoglobin 9 gdL
PT or INR 15 x ULN unless on anti-coagulant therapy
PTT 15 x ULN unless on anti-coagulant therapy
Hepatic
Bilirubin 15 x ULN
ALT 25 x ULN 5 x ULN for patients with liver involvement
AST 25 x ULN 5 x ULN for patients with liver involvement
Renal
Creatinine 15 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None