Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387699
Status:
COMPLETED
Last Update Posted:
2015-04-28
First Post:
2006-10-12
Brief Title:
Bevacizumab Cisplatin Etoposide and Radiation Therapy in Treating Patients With Limited-Stage Small Cell Lung Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
Phase II Trial of Bevacizumab in Combination With CisplatinEtoposide and Twice Daily Radiation for Patients With Limited-Stage Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some find tumor cells and help kill them or carry tumor-killing substances to them Others interfere with the ability of tumor cells to grow and spread Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor Drugs used in chemotherapy such as cisplatin and etoposide work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Radiation therapy uses high-energy x-rays to kill tumor cells Giving bevacizumab together with cisplatin etoposide and radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving bevacizumab together with cisplatin etoposide and radiation therapy works in treating patients with limited-stage small cell lung cancer
PURPOSE This phase II trial is studying how well giving bevacizumab together with cisplatin etoposide and radiation therapy works in treating patients with limited-stage small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the 1-year progression-free survival of patients with limited-stage small cell lung cancer treated with bevacizumab cisplatin etoposide and radiotherapy
Secondary
Determine the toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cisplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity During course 1 patients also undergo thoracic radiotherapy twice daily on days 1-5 8-12 and 15-19
Patients achieving a complete or partial response or stable disease after the first 4 courses of chemotherapy continue to receive bevacizumab IV over 30-90 minutes on day 1 Treatment with bevacizumab repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Within 4-6 weeks after blood counts recover from the first 4 courses of chemotherapy patients achieving a complete or partial response also undergo prophylactic cranial irradiation PCI in 10 fractions over 3 weeks
NOTE Bevacizumab should not be given for 3 weeks prior to or during PCI but resumed 1 week after completion of PCI
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 79 patients will be accrued for this study
Primary
Determine the 1-year progression-free survival of patients with limited-stage small cell lung cancer treated with bevacizumab cisplatin etoposide and radiotherapy
Secondary
Determine the toxicity of this regimen in these patients
Determine the response rate in patients treated with this regimen
OUTLINE This is a multicenter study
Patients receive cisplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 1 and etoposide IV over 60 minutes on days 1-3 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity During course 1 patients also undergo thoracic radiotherapy twice daily on days 1-5 8-12 and 15-19
Patients achieving a complete or partial response or stable disease after the first 4 courses of chemotherapy continue to receive bevacizumab IV over 30-90 minutes on day 1 Treatment with bevacizumab repeats every 21 days for up to 1 year in the absence of disease progression or unacceptable toxicity
Within 4-6 weeks after blood counts recover from the first 4 courses of chemotherapy patients achieving a complete or partial response also undergo prophylactic cranial irradiation PCI in 10 fractions over 3 weeks
NOTE Bevacizumab should not be given for 3 weeks prior to or during PCI but resumed 1 week after completion of PCI
After completion of study treatment patients are followed periodically for 10 years
PROJECTED ACCRUAL A total of 79 patients will be accrued for this study
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ECOG-E1506 | None | None | None |