Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354679
Status:
COMPLETED
Last Update Posted:
2016-05-16
First Post:
2006-07-19
Brief Title:
Irinotecan Cisplatin Bevacizumab Radiation Therapy and Surgery in Treating Patients With Locally Advanced Esophageal Cancer
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Irinotecan Cisplatin Bevacizumab and Concurrent Radiotherapy in Locally Advanced Esophageal Adenocarcinoma
Status:
COMPLETED
Status Verified Date:
2016-04
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:
RATIONALE Drugs used in chemotherapy such as irinotecan and cisplatin 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 find tumor cells and 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 esophageal cancer by blocking blood flow to the tumor Radiation therapy uses high-energy x-rays to kill tumor cells Giving chemotherapy and monoclonal antibody therapy together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Giving bevacizumab after surgery may kill any tumor cells that remain after surgery
PURPOSE This phase II trial is studying how well giving irinotecan cisplatin and bevacizumab together with radiation therapy followed by surgery and bevacizumab works in treating patients with locally advanced esophageal cancer
PURPOSE This phase II trial is studying how well giving irinotecan cisplatin and bevacizumab together with radiation therapy followed by surgery and bevacizumab works in treating patients with locally advanced esophageal cancer
Detailed Description:
OBJECTIVES
Primary
Evaluate the toxicity and safety of bevacizumab when given together with cisplatin irinotecan hydrochloride and radiotherapy followed by surgery and adjuvant bevacizumab in patients with locally advanced esophageal adenocarcinoma
Secondary
Observe the rate of pathologic complete response in patients treated with this regimen
Observe overall survival disease-free survival and patterns of failure in these patients
Clarify toxicity and tolerability of this regimen
Evaluate pre-treatment levels of vascular endothelial growth factor in patient serum as a corollary of response to this regimen
Correlate serum proteomics data with complete pathologic response
OUTLINE This is a nonrandomized open-label study
Induction therapy Patients receive cisplatin IV over 30 minutes and irinotecan hydrochloride IV over 30 minutes on days 1 8 22 and 29 Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 22
Combination therapy and radiotherapy Patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 43 50 64 and 71 Patients also receive bevacizumab IV over 30-90 minutes on days 43 and 64 Patients undergo external beam radiotherapy 5 days a week for 6 weeks beginning on day 43
Surgery Patients undergo surgery 6-8 weeks after finishing combination therapy and radiotherapy
Maintenance therapy Approximately 6 weeks after surgery patients receive bevacizumab IV over 30-90 minutes every 3 weeks for 6 months
Blood samples are obtained at baseline after finishing chemoradiotherapy and prior to maintenance therapy and are examined by the matrix-assisted laser-desorption ionization time of flight MALDI-TOF mass spectometry for proteomic profiling
After completion of study treatment patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 years and then annually thereafter
Primary
Evaluate the toxicity and safety of bevacizumab when given together with cisplatin irinotecan hydrochloride and radiotherapy followed by surgery and adjuvant bevacizumab in patients with locally advanced esophageal adenocarcinoma
Secondary
Observe the rate of pathologic complete response in patients treated with this regimen
Observe overall survival disease-free survival and patterns of failure in these patients
Clarify toxicity and tolerability of this regimen
Evaluate pre-treatment levels of vascular endothelial growth factor in patient serum as a corollary of response to this regimen
Correlate serum proteomics data with complete pathologic response
OUTLINE This is a nonrandomized open-label study
Induction therapy Patients receive cisplatin IV over 30 minutes and irinotecan hydrochloride IV over 30 minutes on days 1 8 22 and 29 Patients also receive bevacizumab IV over 30-90 minutes on days 1 and 22
Combination therapy and radiotherapy Patients receive cisplatin and irinotecan hydrochloride as in induction chemotherapy on days 43 50 64 and 71 Patients also receive bevacizumab IV over 30-90 minutes on days 43 and 64 Patients undergo external beam radiotherapy 5 days a week for 6 weeks beginning on day 43
Surgery Patients undergo surgery 6-8 weeks after finishing combination therapy and radiotherapy
Maintenance therapy Approximately 6 weeks after surgery patients receive bevacizumab IV over 30-90 minutes every 3 weeks for 6 months
Blood samples are obtained at baseline after finishing chemoradiotherapy and prior to maintenance therapy and are examined by the matrix-assisted laser-desorption ionization time of flight MALDI-TOF mass spectometry for proteomic profiling
After completion of study treatment patients are followed every 3 months for 1 year every 4 months for 1 year every 6 months for 3 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 |
|---|---|---|---|
| MSKCC-06013 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |