Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00317200
Status:
COMPLETED
Last Update Posted:
2011-05-02
First Post:
2006-04-20
Brief Title:
A Study of Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer
Sponsor:
Hoosier Cancer Research Network
Organization:
Hoosier Cancer Research Network
Study Overview
Official Title:
Paclitaxel Plus Bevacizumab in Patients With Chemosensitive Relapsed Small Cell Lung Cancer SCLC A Safety Feasibility and Efficacy Study
Status:
COMPLETED
Status Verified Date:
2011-04
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:
Improvements in therapy for relapsed SCLC are much needed Paclitaxel has been previously tested and found to have significant single agent activity in relapsed SCLC including in refractory patients Angiogenesis plays an important role in SCLC increased VEGF levels are associated with worse outcomes Bevacizumab a monoclonal antibody to VEGF increase response rates and survival when combined with chemotherapy agents compared with the chemotherapy agent alone in NSCLC breast cancer and colorectal cancer Paclitaxel plus bevacizumab in the dose and schedule proposed in this study improves response rates and progression free survival compared with paclitaxel alone in women with metastatic breast cancer Therefore we will be testing the safety feasibility and efficacy of this regimen in patients with chemosensitive relapsed SCLC
Detailed Description:
OUTLINE This is a multi-center study
Paclitaxel 90 mgm2 IV infusion over 1 hour days 1 8 and 15 of 28 day cycle
Plus
Bevacizumab 10 mgkg on days 1 and 15 of 28 day cycle
1 cycle 28 days 4 weeks
Disease assessments will be performed per RECIST every other cycle
After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy bevacizumab monotherapy may continue until disease progression or intolerable side effects
ECOG Performance Status 0 or 1
Hematopoietic
White blood cell count 3000 mm3
Absolute neutrophil count ANC 1500 mm3
Platelet count 100000 mm3
International normalized ration INR of prothrombin time 12
PTT no more than 5 seconds longer than the ULN
Hepatic
Bilirubin 15 x ULN
Aspartate aminotransferase AST SGOT 25 x ULN
Renal
Urine proteincreatinine ratio 10
Cardiovascular
No history of myocardial infarction or angina pectorisanginal equivalent in the last 6 months Note The patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months
No history of uncontrolled congestive heart failure or uncontrolled hypertension
Paclitaxel 90 mgm2 IV infusion over 1 hour days 1 8 and 15 of 28 day cycle
Plus
Bevacizumab 10 mgkg on days 1 and 15 of 28 day cycle
1 cycle 28 days 4 weeks
Disease assessments will be performed per RECIST every other cycle
After a minimum of 4 cycles or a maximum of 6 cycles of combination chemotherapy bevacizumab monotherapy may continue until disease progression or intolerable side effects
ECOG Performance Status 0 or 1
Hematopoietic
White blood cell count 3000 mm3
Absolute neutrophil count ANC 1500 mm3
Platelet count 100000 mm3
International normalized ration INR of prothrombin time 12
PTT no more than 5 seconds longer than the ULN
Hepatic
Bilirubin 15 x ULN
Aspartate aminotransferase AST SGOT 25 x ULN
Renal
Urine proteincreatinine ratio 10
Cardiovascular
No history of myocardial infarction or angina pectorisanginal equivalent in the last 6 months Note The patient may be on anti-anginal medications if the symptoms have been entirely controlled for greater than 6 months
No history of uncontrolled congestive heart failure or uncontrolled hypertension
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