Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445861
Status:
COMPLETED
Last Update Posted:
2012-06-11
First Post:
2007-03-07
Brief Title:
Cetuximab Docetaxel Cisplatin and Radiation Therapy in Treating Patients With Locally Advanced Esophageal Cancer That Can Be Removed by Surgery
Sponsor:
Swiss Group for Clinical Cancer Research
Organization:
Swiss Group for Clinical Cancer Research
Study Overview
Official Title:
Cetuximab in Combination With Radiation Therapy and Chemotherapy Prior to Surgery in Patients With Resectable Locally Advanced Esophageal Carcinoma A Multicenter Phase IB-II Trial
Status:
COMPLETED
Status Verified Date:
2012-06
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 Monoclonal antibodies such as cetuximab 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 Drugs used in chemotherapy such as docetaxel and cisplatin 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 cetuximab docetaxel and cisplatin together with radiation therapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed
PURPOSE This phase III trial is studying the side effects of cetuximab docetaxel cisplatin and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery
PURPOSE This phase III trial is studying the side effects of cetuximab docetaxel cisplatin and radiation therapy and to see how well they work in treating patients with locally advanced esophageal cancer that can be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab docetaxel and cisplatin in patients with resectable locally advanced esophageal cancer
Secondary
Determine the feasibility and efficacy of this regimen in these patients
Determine the duration of response and patterns of failure in patients treated with this regimen
OUTLINE This is a multicenter study
Chemoimmunotherapy Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1 Treatment repeats every 3 weeks for 2 courses
Chemoimmunotherapy and radiotherapy Patients are sequentially assigned to 1 of 2 treatment levels
Treatment level 1 Patients receive cetuximab IV over 1 hour once weekly cisplatin IV over 1 hour once weekly and undergo radiotherapy once daily 5 days a week in weeks 7-11
Treatment level 2 Patients receive cetuximab cisplatin and radiotherapy as in treatment level 1 Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11
Cohorts of 7-20 patients are treated at treatment level 1 or 2 sequentially as long as no more than 2 of 7 patients experience dose-limiting toxicity DLT until the safe treatment level for future study is determined The safe treatment level is defined as the level at which no more than 2 of 7 and no more than 6 of 20 patients experience DLT At least 20 patients are treated at the safe treatment level
Surgery Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy patients undergo surgery
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 27 patients will be accrued for this study
Primary
Determine the safety of neoadjuvant radiotherapy in combination with cetuximab docetaxel and cisplatin in patients with resectable locally advanced esophageal cancer
Secondary
Determine the feasibility and efficacy of this regimen in these patients
Determine the duration of response and patterns of failure in patients treated with this regimen
OUTLINE This is a multicenter study
Chemoimmunotherapy Patients receive cetuximab IV over 1-2 hours once weekly in weeks 1-3 and docetaxel IV over 1 hour and cisplatin IV over 1 hour once in week 1 Treatment repeats every 3 weeks for 2 courses
Chemoimmunotherapy and radiotherapy Patients are sequentially assigned to 1 of 2 treatment levels
Treatment level 1 Patients receive cetuximab IV over 1 hour once weekly cisplatin IV over 1 hour once weekly and undergo radiotherapy once daily 5 days a week in weeks 7-11
Treatment level 2 Patients receive cetuximab cisplatin and radiotherapy as in treatment level 1 Patients also receive docetaxel IV over 1-2 hours once weekly in weeks 7-11
Cohorts of 7-20 patients are treated at treatment level 1 or 2 sequentially as long as no more than 2 of 7 patients experience dose-limiting toxicity DLT until the safe treatment level for future study is determined The safe treatment level is defined as the level at which no more than 2 of 7 and no more than 6 of 20 patients experience DLT At least 20 patients are treated at the safe treatment level
Surgery Between 4-8 weeks after completion of neoadjuvant chemoimmunotherapy and radiotherapy patients undergo surgery
After completion of study treatment patients are followed every 3 months for 1 year every 6 months for 3 years and then annually thereafter
PROJECTED ACCRUAL A total of 27 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 |
|---|---|---|---|
| EU-20702 | None | None | None |