Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00334763
Status:
TERMINATED
Last Update Posted:
2012-07-10
First Post:
2006-06-07
Brief Title:
Radiation Therapy Chemotherapy and Bevacizumab in Treating Patients With Recurrent Unresectable or Stage III or Stage IV Non-Small Cell Lung Cancer
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
Official Title:
Phase II Study of Radiation Followed by Paclitaxel Carboplatin and Bevacizumab PCA in Patients With Stage IIIB and IV Squamous Non-Small Cell Lung Cancer
Status:
TERMINATED
Status Verified Date:
2012-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Principal Investigator felt risk to patients was too high
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
RATIONALE Radiation therapy uses high-energy x-rays to kill tumor cells 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 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 tumor cells by blocking blood flow to the tumor Giving radiation therapy together with chemotherapy and monoclonal antibody therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving radiation therapy together with chemotherapy and bevacizumab works in treating patients with recurrent unresectable or stage III or stage IV non-small cell lung cancer
PURPOSE This phase II trial is studying how well giving radiation therapy together with chemotherapy and bevacizumab works in treating patients with recurrent unresectable or stage III or stage IV non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate reduction in toxicity in terms of pulmonary hemorrhage in patients with recurrent unresectable or stage IIIB or IV squamous non-small cell lung cancer treated with radiotherapy followed by paclitaxel carboplatin and bevacizumab
Secondary
Determine the overall and progression-free survival of patients treated with this regimen
OUTLINE Patients undergo radiotherapy to the primary tumor clinically involved lymph nodes and any other disease-causing symptoms or bronchial compression once daily 5 days a week for 2 weeks in weeks 1 and 2 Beginning in week 4 patients receive paclitaxel IV over 3 hours carboplatin IV over 15-30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment with paclitaxel carboplatin and bevacizumab repeats every 3 weeks for 4 courses in the absence of unacceptable toxicity Patients achieving complete response partial response or stable disease after 4 courses receive bevacizumab alone as above in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months
PROJECTED ACCRUAL A total of 32 patients will be accrued for this study
Primary
Evaluate reduction in toxicity in terms of pulmonary hemorrhage in patients with recurrent unresectable or stage IIIB or IV squamous non-small cell lung cancer treated with radiotherapy followed by paclitaxel carboplatin and bevacizumab
Secondary
Determine the overall and progression-free survival of patients treated with this regimen
OUTLINE Patients undergo radiotherapy to the primary tumor clinically involved lymph nodes and any other disease-causing symptoms or bronchial compression once daily 5 days a week for 2 weeks in weeks 1 and 2 Beginning in week 4 patients receive paclitaxel IV over 3 hours carboplatin IV over 15-30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment with paclitaxel carboplatin and bevacizumab repeats every 3 weeks for 4 courses in the absence of unacceptable toxicity Patients achieving complete response partial response or stable disease after 4 courses receive bevacizumab alone as above in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 6 months
PROJECTED ACCRUAL A total of 32 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 |
|---|---|---|---|
| NU-05L1 | None | None | None |
| NU-1362-038 | None | None | None |
| GENENTECH-AVF3646s | None | None | None |