Ignite Creation Date:
2024-05-05 @ 11:26 AM
Last Modification Date:
2024-10-26 @ 9:07 AM
Study NCT ID:
NCT00042939
Status:
COMPLETED
Last Update Posted:
2023-07-06
First Post:
2002-08-05
Brief Title:
Irinotecan and Docetaxel With or Without Cetuximab in Treating Patients With Metastatic Pancreatic Cancer
Sponsor:
Eastern Cooperative Oncology Group
Organization:
Eastern Cooperative Oncology Group
Study Overview
Official Title:
Phase II Trial of IrinotecanDocetaxel for Advanced Pancreatic Cancer With Randomization Between IrinotecanDocetaxel and IrinotecanDocetaxel Plus C225 a Monoclonal Antibody to the Epidermal Growth Factor Receptor EGF-r
Status:
COMPLETED
Status Verified Date:
2023-06
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 Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Combining chemotherapy with cetuximab may kill more tumor cells
PURPOSE This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer
PURPOSE This randomized phase II trial is studying giving irinotecan and docetaxel together with cetuximab to see how well it works compared to irinotecan and docetaxel alone in treating patients with metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Determine the efficacy of irinotecan and docetaxel with or without cetuximab in terms of objective response rate in patients with metastatic adenocarcinoma of the pancreas
Determine the time to progression and overall survival of patients treated with these regimens
Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm A Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1 8 15 and 22
Arm B Patients receive docetaxel and irinotecan as in arm A Patients also receive cetuximab IV over 1-2 hours on days 1 8 15 22 29 and 36
Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 92 patients 46 per treatment arm
Determine the efficacy of irinotecan and docetaxel with or without cetuximab in terms of objective response rate in patients with metastatic adenocarcinoma of the pancreas
Determine the time to progression and overall survival of patients treated with these regimens
Determine the proportion of patients with tumors that overexpress epidermal growth factor receptor
OUTLINE This is a randomized multicenter study Patients are randomized to 1 of 2 treatment arms
Arm A Patients receive docetaxel IV over 1 hour and irinotecan IV over 30 minutes weekly on days 1 8 15 and 22
Arm B Patients receive docetaxel and irinotecan as in arm A Patients also receive cetuximab IV over 1-2 hours on days 1 8 15 22 29 and 36
Courses repeat in both arms every 6 weeks in the absence of disease progression or unacceptable toxicity
Patients are followed every 3 months for 2 years every 6 months for 1 year and then periodically thereafter
PROJECTED ACCRUAL A total of 92 patients 46 per treatment arm
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 |
|---|---|---|---|
| U10CA021115 | NIH | None | None |
| E8200 ECOG | OTHER | Eastern Cooperative Oncology Group ECOG | httpsreporternihgovquickSearchU10CA021115 |