Ignite Creation Date:
2024-05-05 @ 5:08 PM
Last Modification Date:
2024-10-26 @ 9:28 AM
Study NCT ID:
NCT00397904
Status:
COMPLETED
Last Update Posted:
2015-11-25
First Post:
2006-11-09
Brief Title:
Cetuximab Cisplatin and Irinotecan in Treating Patients With Metastatic Esophageal Cancer Gastroesophageal Junction Cancer or Gastric Cancer That Did Not Respond to Previous Irinotecan and Cisplatin
Sponsor:
Memorial Sloan Kettering Cancer Center
Organization:
Memorial Sloan Kettering Cancer Center
Study Overview
Official Title:
Phase II Trial of Cetuximab Plus Cisplatin and Irinotecan in Patients With Irinotecan and Cisplatin-Refractory Metastatic Esophageal and Gastric Cancer
Status:
COMPLETED
Status Verified Date:
2015-10
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 Cetuximab may also stop the growth of tumor cells by blocking some of the enzymes needed for their 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 Giving cetuximab together with cisplatin and irinotecan may kill more tumor cells
PURPOSE This phase II trial is studying how well giving cetuximab together with cisplatin and irinotecan works in treating patients with metastatic esophageal cancer gastroesophageal junction cancer or gastric cancer that did not respond to previous irinotecan and cisplatin
PURPOSE This phase II trial is studying how well giving cetuximab together with cisplatin and irinotecan works in treating patients with metastatic esophageal cancer gastroesophageal junction cancer or gastric cancer that did not respond to previous irinotecan and cisplatin
Detailed Description:
OBJECTIVES
Primary
Determine the response rate in patients with irinotecan hydrochloride- and cisplatin-refractory metastatic esophageal gastroesophageal junction or gastric cancer treated with cetuximab cisplatin and irinotecan hydrochloride
Secondary
Determine the median survival of patients treated with this regimen
Determine the tolerability of this regimen in these patients
Determine the adverse event profiles in patients treated with this regimen
Assess epidermal growth factor receptor expression in tumor tissue from patients treated with this regimen
OUTLINE This is an open-label nonrandomized study
Patients receive cetuximab IV over 60-120 minutes on days 1 8 and 15 and cisplatin IV over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients undergo tumor biopsy at baseline to evaluate epidermal growth factor receptor by immunohistochemistry
After completion of study treatment patients are followed every 3 months for up to 1 year
Primary
Determine the response rate in patients with irinotecan hydrochloride- and cisplatin-refractory metastatic esophageal gastroesophageal junction or gastric cancer treated with cetuximab cisplatin and irinotecan hydrochloride
Secondary
Determine the median survival of patients treated with this regimen
Determine the tolerability of this regimen in these patients
Determine the adverse event profiles in patients treated with this regimen
Assess epidermal growth factor receptor expression in tumor tissue from patients treated with this regimen
OUTLINE This is an open-label nonrandomized study
Patients receive cetuximab IV over 60-120 minutes on days 1 8 and 15 and cisplatin IV over 30 minutes and irinotecan hydrochloride IV over 30-90 minutes on days 1 and 8 Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity
Patients undergo tumor biopsy at baseline to evaluate epidermal growth factor receptor by immunohistochemistry
After completion of study treatment patients are followed every 3 months for up to 1 year
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-06095 | US NIH GrantContract | None | httpsreporternihgovquickSearchP30CA008748 |
| P30CA008748 | NIH | None | None |