Ignite Creation Date:
2024-05-05 @ 11:40 AM
Last Modification Date:
2024-10-26 @ 9:11 AM
Study NCT ID:
NCT00109850
Status:
TERMINATED
Last Update Posted:
2015-11-18
First Post:
2005-05-03
Brief Title:
S0414 Cetuximab Combo Chemo and RT in Locally Advanced Esophageal Cancer
Sponsor:
SWOG Cancer Research Network
Organization:
SWOG Cancer Research Network
Study Overview
Official Title:
Cetuximab Plus Cisplatin Irinotecan and Thoracic Radiotherapy TRT for Locally Advanced Non-Metastatic Clinically Unresectable Esophageal Cancer A Phase II Trial With Molecular Correlates
Status:
TERMINATED
Status Verified Date:
2015-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Closed due to poor accrual
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 Cetuximab may also stop the growth of esophageal cancer by blocking blood flow to the tumor and by blocking some of the enzymes needed for cell growth Drugs used in chemotherapy such as cisplatin and irinotecan 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 together with combination chemotherapy and radiation therapy may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving cetuximab together with combination chemotherapy and radiation therapy works in treating patients with locally advanced esophageal cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the 2-year overall survival of patients with previously untreated clinically unresectable locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab cisplatin irinotecan and thoracic radiotherapy
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the probability of objective response confirmed and unconfirmed complete and partial in patients with measurable disease treated with this regimen
Determine the time to progression in patients with measurable disease treated with this regimen
Correlate preliminarily gene expression RNA levels and germline polymorphisms of genes involved in DNA repair eg ECRCC-1 and XRCC-1 drug metabolism eg UGT1A1 and the epidermal growth factor receptor EGFR pathway eg EGFR interleukin-8 and vascular endothelial growth factor with response time to progression overall survival and toxicity in patients treated with this regimen This will not be completed as this study was closed due to poor accrual
OUTLINE This is a multicenter study
Patients receive cetuximab intravenous IV over 1-2 hours on days 1 8 and 15 Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Beginning on day 1 of course 3 patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks total of 28 treatments
After completion of study treatment patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry
PROJECTED ACCRUAL A total of 75-100 patients 75 with adenocarcinoma and 25 with squamous cell carcinoma will be accrued for this study
Primary
Determine the 2-year overall survival of patients with previously untreated clinically unresectable locally advanced squamous cell carcinoma or adenocarcinoma of the esophagus treated with cetuximab cisplatin irinotecan and thoracic radiotherapy
Secondary
Determine the toxicity profile of this regimen in these patients
Determine the probability of objective response confirmed and unconfirmed complete and partial in patients with measurable disease treated with this regimen
Determine the time to progression in patients with measurable disease treated with this regimen
Correlate preliminarily gene expression RNA levels and germline polymorphisms of genes involved in DNA repair eg ECRCC-1 and XRCC-1 drug metabolism eg UGT1A1 and the epidermal growth factor receptor EGFR pathway eg EGFR interleukin-8 and vascular endothelial growth factor with response time to progression overall survival and toxicity in patients treated with this regimen This will not be completed as this study was closed due to poor accrual
OUTLINE This is a multicenter study
Patients receive cetuximab intravenous IV over 1-2 hours on days 1 8 and 15 Patients also receive cisplatin IV and irinotecan IV over 30 minutes on days 1 and 8 Treatment repeats every 21 days for 4 courses in the absence of disease progression or unacceptable toxicity Beginning on day 1 of course 3 patients undergo thoracic radiotherapy once daily 5 days a week for 5-6 weeks total of 28 treatments
After completion of study treatment patients are followed at 4 weeks and then every 3-6 months for up to 5 years after study entry
PROJECTED ACCRUAL A total of 75-100 patients 75 with adenocarcinoma and 25 with squamous cell carcinoma 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 |
|---|---|---|---|
| U10CA032102 | NIH | SWOG | httpsreporternihgovquickSearchU10CA032102 |
| S0414 | OTHER | None | None |