Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00367601
Status:
COMPLETED
Last Update Posted:
2016-02-11
First Post:
2006-08-21
Brief Title:
Erlotinib Bevacizumab for PS 2 Chemotherapy Naïve Non-Small Cell Lung Cancer
Sponsor:
Nasser Hanna MD
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
A Phase II Study of Erlotinib With Bevacizumab in Chemotherapy Naïve Performance Status PS 2 Patients With Advanced Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2016-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The strategy for combining therapeutic agents in cancer treatments has been successful in multiple tumor types including NSCLC Erlotinib and bevacizumab target different pathways involved in tumor growth Nonclinical studies have demonstrated that the combination of bevacizumab and erlotinib results in greater efficacy than either agent alone Furthermore because there is little to no overlap in toxicity profile between the two agents the combination is expected to be well tolerated and may provide even greater benefit for patients who are unable to receive cytotoxic therapy
Detailed Description:
OUTLINE This is a multi-center study
Bevacizumab 15 mgkg IV on day 1
Erlotinib 150 mg po qd days 1-21
Disease Assessment during even numbered cycles
If no progressive disease observed continue combination or single agent- see below until unacceptable toxicity or progressive disease
If progressive disease observed treatment will be discontinued
Cycles will be repeated every 21 days up to a total of 6 cycles
Patients with non-progression after 6 cycles may stay on therapy single agent erlotinib or the combination until progressive disease or intolerable toxicity at the physician discretion
Patients who require discontinuation of bevacizumab may receive at investigators discretion erlotinib alone on study until progression
Patients who require discontinuation of erlotinib may receive at investigators discretion bevacizumab alone until progression
ECOG Performance Status 2
Hematopoietic
Absolute neutrophil count ANC 1000 mm3
Platelet count 100000 mm3
Hemoglobin 8 gdl
Hepatic
Bilirubin 2 X upper limit of normal
Aspartate aminotransferase AST SGOT 25 X upper limit of normal or 5 X if liver involvement
Renal
Urine proteincreatinine ratio 10 at screening
Cardiovascular
Blood pressure of 150100 mmHg
No history of unstable angina
No history of New York Heart Association NYHA Grade II or greater congestive heart failure
No history of myocardial infarction within 6 months prior to registration for protocol therapy
No history of stroke within 6 months prior to registration for protocol therapy
No clinically significant peripheral vascular disease
Bevacizumab 15 mgkg IV on day 1
Erlotinib 150 mg po qd days 1-21
Disease Assessment during even numbered cycles
If no progressive disease observed continue combination or single agent- see below until unacceptable toxicity or progressive disease
If progressive disease observed treatment will be discontinued
Cycles will be repeated every 21 days up to a total of 6 cycles
Patients with non-progression after 6 cycles may stay on therapy single agent erlotinib or the combination until progressive disease or intolerable toxicity at the physician discretion
Patients who require discontinuation of bevacizumab may receive at investigators discretion erlotinib alone on study until progression
Patients who require discontinuation of erlotinib may receive at investigators discretion bevacizumab alone until progression
ECOG Performance Status 2
Hematopoietic
Absolute neutrophil count ANC 1000 mm3
Platelet count 100000 mm3
Hemoglobin 8 gdl
Hepatic
Bilirubin 2 X upper limit of normal
Aspartate aminotransferase AST SGOT 25 X upper limit of normal or 5 X if liver involvement
Renal
Urine proteincreatinine ratio 10 at screening
Cardiovascular
Blood pressure of 150100 mmHg
No history of unstable angina
No history of New York Heart Association NYHA Grade II or greater congestive heart failure
No history of myocardial infarction within 6 months prior to registration for protocol therapy
No history of stroke within 6 months prior to registration for protocol therapy
No clinically significant peripheral vascular disease
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