Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00005591
Status:
WITHDRAWN
Last Update Posted:
2013-12-13
First Post:
2000-05-02
Brief Title:
Cetuximab Plus Gemcitabine in Treating Patients With Locally Advanced Metastatic or Recurrent Cancer of the Pancreas
Sponsor:
University of Alabama at Birmingham
Organization:
University of Alabama at Birmingham
Study Overview
Official Title:
Phase II Study of Anti-Epidermal Growth Factor Receptor EGFr Antibody C225 in Combination With Gemcitabine in Patients With Advanced Pancreatic Cancer
Status:
WITHDRAWN
Status Verified Date:
2007-04
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 Monoclonal antibodies such as cetuximab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells Drugs used in chemotherapy use different ways to stop tumor cell from dividing so they stop growing or die Combining chemotherapy with monoclonal antibody therapy may kill more tumor cells
PURPOSE Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating patients who have locally advanced metastatic or recurrent cancer of the pancreas
PURPOSE Phase II trial to study the effectiveness of cetuximab plus gemcitabine in treating patients who have locally advanced metastatic or recurrent cancer of the pancreas
Detailed Description:
OBJECTIVES I Determine objective response time to progression survival clinical benefit response and quality of life of patients with locally advanced metastatic or recurrent adenocarcinoma of the pancreas when treated with cetuximab and gemcitabine II Determine the safety and toxicity profile of this regimen in this patient population
OUTLINE This is a multicenter study Patients receive a test dose of cetuximab IV over 10 minutes followed by a 30 minute observation period Following observation patients receive a loading dose of cetuximab IV over 1-2 hours followed 1 hour later by gemcitabine IV over 30 minutes weekly for 7 weeks Following 1 week of rest patients with stable or responding disease continue treatment for a maximum of 6 months During subsequent courses patients receive maintenance doses of cetuximab IV over 1 hour weekly for 8 weeks Gemcitabine IV is administered over 30 minutes weekly for 3 weeks followed by 1 week of rest and then repeated for a total treatment course of 8 weeks Treatment continues in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline after each course of therapy and at 3 months after therapy Patients are followed every 3 months until evidence of disease progression
PROJECTED ACCRUAL A minimum of 40 patients will be accrued for this study within 8 months
OUTLINE This is a multicenter study Patients receive a test dose of cetuximab IV over 10 minutes followed by a 30 minute observation period Following observation patients receive a loading dose of cetuximab IV over 1-2 hours followed 1 hour later by gemcitabine IV over 30 minutes weekly for 7 weeks Following 1 week of rest patients with stable or responding disease continue treatment for a maximum of 6 months During subsequent courses patients receive maintenance doses of cetuximab IV over 1 hour weekly for 8 weeks Gemcitabine IV is administered over 30 minutes weekly for 3 weeks followed by 1 week of rest and then repeated for a total treatment course of 8 weeks Treatment continues in the absence of unacceptable toxicity or disease progression Quality of life is assessed at baseline after each course of therapy and at 3 months after therapy Patients are followed every 3 months until evidence of disease progression
PROJECTED ACCRUAL A minimum of 40 patients will be accrued for this study within 8 months
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 |
|---|---|---|---|
| NCI-G00-1729 | None | None | None |
| UAB-9929 | None | None | None |
| IMCL-CP02-9814 | None | None | None |
| UAB-F990927003 | None | None | None |