Ignite Creation Date:
2024-05-05 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00280150
Status:
COMPLETED
Last Update Posted:
2017-06-19
First Post:
2006-01-19
Brief Title:
Combination Chemotherapy Bev RT and Erlotinib in Treating Patients With Stage III Non-Small Cell Lung Cancer
Sponsor:
UNC Lineberger Comprehensive Cancer Center
Organization:
UNC Lineberger Comprehensive Cancer Center
Study Overview
Official Title:
Phase III Trial of Induction CarboplatinPaclitaxel With Bevacizumab Followed by Concurrent Thoracic Conformal Radiation Therapy With CarboplatinPaclitaxel Bevacizumab and Erlotinib in Stage IIIAB Non-Small Cell Lung Cancer
Status:
COMPLETED
Status Verified Date:
2017-05
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:
RATIONALE Drugs used in chemotherapy such as carboplatin and paclitaxel 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 non-small cell lung cancer by blocking blood flow to the tumor Radiation therapy uses high energy x-rays to kill tumor cells Erlotinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth Giving combination chemotherapy together with bevacizumab radiation therapy and erlotinib may kill more tumor cells
PURPOSE This phase III trial is studying the side effects and best dose of bevacizumab and erlotinib when given together with combination chemotherapy and radiation therapy and to see how well they work in treating patients with stage III non-small cell lung cancer
PURPOSE This phase III trial is studying the side effects and best dose of bevacizumab and erlotinib when given together with combination chemotherapy and radiation therapy and to see how well they work in treating patients with stage III non-small cell lung cancer
Detailed Description:
OBJECTIVES
Primary
Determine the maximum tolerated dose of bevacizumab and erlotinib hydrochloride when given together with carboplatin paclitaxel and thoracic conformal radiotherapy in patients with stage IIIA or IIIB non-small cell lung cancer Phase I closed to accrual as of 132008
Determine the safety and toxicity profile of this regimen in these patients Phase I closed to accrual as of 132008
Determine the progression-free survival of patients treated with induction therapy comprising carboplatin paclitaxel and bevacizumab followed by chemoradiotherapy comprising thoracic conformal radiotherapy carboplatin paclitaxel bevacizumab and erlotinib hydrochloride and consolidation therapy comprising bevacizumab and erlotinib hydrochloride Phase II
Determine the overall toxicity profile of this regimen in these patients Phase II
Secondary
Determine the response rate in patients treated with induction therapy comprising carboplatin paclitaxel and bevacizumab Phase Iclosed to accrual as of 132008 and II
Determine the toxicity profile of induction therapy in these patients Phase I closed to accrual as of 132008 and II
Determine the overall response rate and survival profile in patients treated with this regimen Phase I closed to accrual as of 132008 and II
Determine the feasibility and tolerability of administering consolidation therapy comprising erlotinib hydrochloride and bevacizumab after treatment with combined modality therapy induction therapy and chemoradiotherapy in these patients Phase I closed to accrual as of 132008 and II
Collect tumor and blood samples from these patients for future analysis of correlation between molecular markers and clinical benefit Phase I closed to accrual as of 132008 and II
OUTLINE This is a nonrandomized open-label controlled phase I closed to accrual as of 132008 dose-escalation study of bevacizumab and erlotinib hydrochloride followed by a phase II study
Phase I closed to accrual as of 132008
Induction therapy Patients receive paclitaxel IV over 3 hours carboplatin IV over 15-30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients with stable or responding disease proceed to chemoradiotherapy
Chemoradiotherapy Patients receive chemoradiotherapy according to their assigned dose cohort
Cohort 1 Patients undergo thoracic conformal radiotherapy TCRT on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47 Patients also receive carboplatin IV and paclitaxel IV on days 1 8 15 22 29 36 and 43 and bevacizumab IV over 30-90 minutes on days 1 15 29 and 43
Cohort 2 Patients undergo TCRT and receive carboplatin paclitaxel and bevacizumab as in cohort 1 Patients also receive oral erlotinib hydrochloride on days 2-5 9-12 16-19 23-26 30-33 37-40 and 44-47
Cohort 3 Patients undergo TCRT and receive carboplatin paclitaxel and bevacizumab as in cohort 1 Patients also receive higher doses of oral erlotinib hydrochloride on days 2-5 9-12 16-19 23-26 30-33 37-40 and 44-47
Cohorts of 5 patients receive chemoradiotherapy as described above until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 with grade 4 toxicity or 3 with grade 3 toxicity of 5 patients experience dose-limiting toxicity
Three to 6 weeks after completion of chemoradiotherapy patients proceed to consolidation therapy
Consolidation therapy Patients receive bevacizumab IV on day 1 and oral erlotinib hydrochloride on days 1-21 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Phase II
Induction therapy Patients receive induction therapy as in phase I closed to accrual as of 132008
Chemoradiotherapy Patients undergo TCRT and receive carboplatin and paclitaxel as in phase I closed to accrual as of 132008 Patients also receive bevacizumab and erlotinib hydrochloride as in phase I closed to accrual as of 132008 at the MTDdrug combination determined in phase I closed to accrual as of 132008
Consolidation therapy Patients receive consolidation therapy as in phase I closed to accrual as of 132008
Tumor tissue and peripheral blood is collected at baseline for future correlative and biomarker studies
After completion of study therapy patients are followed every 2 months for 2 years every 4 months for 2 years every 6 months for 2 years and then annually thereafter
Primary
Determine the maximum tolerated dose of bevacizumab and erlotinib hydrochloride when given together with carboplatin paclitaxel and thoracic conformal radiotherapy in patients with stage IIIA or IIIB non-small cell lung cancer Phase I closed to accrual as of 132008
Determine the safety and toxicity profile of this regimen in these patients Phase I closed to accrual as of 132008
Determine the progression-free survival of patients treated with induction therapy comprising carboplatin paclitaxel and bevacizumab followed by chemoradiotherapy comprising thoracic conformal radiotherapy carboplatin paclitaxel bevacizumab and erlotinib hydrochloride and consolidation therapy comprising bevacizumab and erlotinib hydrochloride Phase II
Determine the overall toxicity profile of this regimen in these patients Phase II
Secondary
Determine the response rate in patients treated with induction therapy comprising carboplatin paclitaxel and bevacizumab Phase Iclosed to accrual as of 132008 and II
Determine the toxicity profile of induction therapy in these patients Phase I closed to accrual as of 132008 and II
Determine the overall response rate and survival profile in patients treated with this regimen Phase I closed to accrual as of 132008 and II
Determine the feasibility and tolerability of administering consolidation therapy comprising erlotinib hydrochloride and bevacizumab after treatment with combined modality therapy induction therapy and chemoradiotherapy in these patients Phase I closed to accrual as of 132008 and II
Collect tumor and blood samples from these patients for future analysis of correlation between molecular markers and clinical benefit Phase I closed to accrual as of 132008 and II
OUTLINE This is a nonrandomized open-label controlled phase I closed to accrual as of 132008 dose-escalation study of bevacizumab and erlotinib hydrochloride followed by a phase II study
Phase I closed to accrual as of 132008
Induction therapy Patients receive paclitaxel IV over 3 hours carboplatin IV over 15-30 minutes and bevacizumab IV over 30-90 minutes on day 1 Treatment repeats every 21 days for 2 courses Patients with stable or responding disease proceed to chemoradiotherapy
Chemoradiotherapy Patients receive chemoradiotherapy according to their assigned dose cohort
Cohort 1 Patients undergo thoracic conformal radiotherapy TCRT on days 1-5 8-12 15-19 22-26 29-33 36-40 and 43-47 Patients also receive carboplatin IV and paclitaxel IV on days 1 8 15 22 29 36 and 43 and bevacizumab IV over 30-90 minutes on days 1 15 29 and 43
Cohort 2 Patients undergo TCRT and receive carboplatin paclitaxel and bevacizumab as in cohort 1 Patients also receive oral erlotinib hydrochloride on days 2-5 9-12 16-19 23-26 30-33 37-40 and 44-47
Cohort 3 Patients undergo TCRT and receive carboplatin paclitaxel and bevacizumab as in cohort 1 Patients also receive higher doses of oral erlotinib hydrochloride on days 2-5 9-12 16-19 23-26 30-33 37-40 and 44-47
Cohorts of 5 patients receive chemoradiotherapy as described above until the maximum tolerated dose MTD is determined The MTD is defined as the dose preceding that at which 2 with grade 4 toxicity or 3 with grade 3 toxicity of 5 patients experience dose-limiting toxicity
Three to 6 weeks after completion of chemoradiotherapy patients proceed to consolidation therapy
Consolidation therapy Patients receive bevacizumab IV on day 1 and oral erlotinib hydrochloride on days 1-21 Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity
Phase II
Induction therapy Patients receive induction therapy as in phase I closed to accrual as of 132008
Chemoradiotherapy Patients undergo TCRT and receive carboplatin and paclitaxel as in phase I closed to accrual as of 132008 Patients also receive bevacizumab and erlotinib hydrochloride as in phase I closed to accrual as of 132008 at the MTDdrug combination determined in phase I closed to accrual as of 132008
Consolidation therapy Patients receive consolidation therapy as in phase I closed to accrual as of 132008
Tumor tissue and peripheral blood is collected at baseline for future correlative and biomarker studies
After completion of study therapy patients are followed every 2 months for 2 years every 4 months for 2 years every 6 months for 2 years and then annually thereafter
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 |
|---|---|---|---|
| UNC IRB 05-2091 | None | None | None |