Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00387374
Status:
COMPLETED
Last Update Posted:
2013-01-17
First Post:
2006-10-12
Brief Title:
Radiation Therapy Bevacizumab Paclitaxel and Carboplatin in Treating Patients With Unresectable Stage IIIB or Stage IV Non-Small Cell Lung Cancer at High Risk for Hemoptysis Caused by Bevacizumab
Sponsor:
National Cancer Institute NCI
Organization:
National Cancer Institute NCI
Study Overview
Official Title:
A Phase II Study of Prophylactic Radiation Therapy for the Prevention of Hemoptysis in Advanced Non Small Cell Lung Cancer in Combination With Bevacizumab Paclitaxel and Carboplatin in Patients at High Risk for Bevacizumab-Associated Hemoptysis
Status:
COMPLETED
Status Verified Date:
2013-01
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:
This phase II trial is studying the side effects and how well giving radiation therapy together with bevacizumab paclitaxel and carboplatin works in treating patients with unresectable stage IIIB or stage IV non-small cell lung cancer at high risk for hemoptysis caused by bevacizumab Radiation therapy uses high-energy x-rays to kill tumor cells It may also prevent hemoptysis caused by bevacizumab Monoclonal antibodies such as bevacizumab can block tumor growth in different ways Some block the ability of tumor cells to grow and spread Others find tumor cells and help kill them or carry tumor-killing substances to them Bevacizumab may also stop the growth of non-small cell lung cancer by blocking blood flow to the tumor Drugs used in chemotherapy such as paclitaxel and carboplatin work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Giving radiation therapy together with bevacizumab and chemotherapy may kill more tumor cells
Detailed Description:
PRIMARY OBJECTIVES
I Evaluate the safety of prophylactic chest radiotherapy bevacizumab paclitaxel and carboplatin in patients with unresectable stage IIIB or IV non-small cell lung cancer at high risk for bevacizumab-associated hemoptysis
SECONDARY OBJECTIVES
I Assess progression-free survival of patients treated with this regimen II Assess the rate of objective response overall survival time to response and response duration in irradiated lesions and non-irradiated lesions in these patients
OUTLINE This is an open-label pilot multicenter study Patients are assigned sequentially to 1 of 2 treatment strata
Stratum I Patients undergo prophylactic radiotherapy on days 1-5 and 8-12 Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 15 Patients also receive paclitaxel IV over 3 hours or carboplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 36 course 2
Stratum II Patients undergo prophylactic radiotherapy and receive paclitaxel and carboplatin as in stratum I Patients also receive bevacizumab IV over 30-90 minutes on day 15 course 1 In both strata treatment with paclitaxel carboplatin and bevacizumab repeats every 21 days for 5-6 courses in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or stable disease may continue to receive single-agent bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 12 months
PROJECTED ACCRUAL A total of 72 patients will be accrued for this study
I Evaluate the safety of prophylactic chest radiotherapy bevacizumab paclitaxel and carboplatin in patients with unresectable stage IIIB or IV non-small cell lung cancer at high risk for bevacizumab-associated hemoptysis
SECONDARY OBJECTIVES
I Assess progression-free survival of patients treated with this regimen II Assess the rate of objective response overall survival time to response and response duration in irradiated lesions and non-irradiated lesions in these patients
OUTLINE This is an open-label pilot multicenter study Patients are assigned sequentially to 1 of 2 treatment strata
Stratum I Patients undergo prophylactic radiotherapy on days 1-5 and 8-12 Patients receive paclitaxel IV over 3 hours and carboplatin IV over 30-60 minutes on day 15 Patients also receive paclitaxel IV over 3 hours or carboplatin IV over 30-60 minutes and bevacizumab IV over 30-90 minutes on day 36 course 2
Stratum II Patients undergo prophylactic radiotherapy and receive paclitaxel and carboplatin as in stratum I Patients also receive bevacizumab IV over 30-90 minutes on day 15 course 1 In both strata treatment with paclitaxel carboplatin and bevacizumab repeats every 21 days for 5-6 courses in the absence of disease progression or unacceptable toxicity Patients with complete or partial response or stable disease may continue to receive single-agent bevacizumab every 21 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed periodically for 12 months
PROJECTED ACCRUAL A total of 72 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 |
|---|---|---|---|
| CCC-PHII-78 | None | None | None |
| N01CM62208 | NIH | None | None |
| N01CM62201 | NIH | None | None |
| N01CM62203 | NIH | None | None |
| N01CM62209 | NIH | None | None |
| CDR0000504067 | REGISTRY | PDQ Physician Data Query | httpsreporternihgovquickSearchN01CM62209 |