Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00448838
Status:
COMPLETED
Last Update Posted:
2016-12-15
First Post:
2007-03-15
Brief Title:
Cetuximab Gemcitabine and Oxaliplatin in Treating Patients With Locally Advanced or Metastatic Pancreatic Cancer
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Pilot Study of Gemcitabine Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2016-12
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 pancreatic cancer by blocking blood flow to the tumor Drugs used in chemotherapy such as gemcitabine and oxaliplatin 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 combination chemotherapy may kill more tumor cells
PURPOSE This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer
PURPOSE This clinical trial is studying how well giving cetuximab together with gemcitabine and oxaliplatin works in treating patients with locally advanced or metastatic pancreatic cancer
Detailed Description:
OBJECTIVES
Primary
Determine the progression-free survival of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab gemcitabine hydrochloride and oxaliplatin
Secondary
Determine the complete response and partial response in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the duration of response in patients treated with this regimen
Determine the survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a nonrandomized open-label pilot study
Patients receive cetuximab IV over 1-2 hours on days 1 and 8 gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2-4 hours on day 2 Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 patients will be accrued for this study
Primary
Determine the progression-free survival of patients with locally advanced or metastatic pancreatic cancer treated with cetuximab gemcitabine hydrochloride and oxaliplatin
Secondary
Determine the complete response and partial response in patients treated with this regimen
Determine the time to progression in patients treated with this regimen
Determine the duration of response in patients treated with this regimen
Determine the survival of patients treated with this regimen
Determine the toxicity of this regimen in these patients
OUTLINE This is a nonrandomized open-label pilot study
Patients receive cetuximab IV over 1-2 hours on days 1 and 8 gemcitabine hydrochloride IV over 100 minutes on day 1 and oxaliplatin IV over 2-4 hours on day 2 Treatment repeats every 14 days in the absence of disease progression or unacceptable toxicity
After completion of study treatment patients are followed every 3 months
PROJECTED ACCRUAL A total of 40 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 |
|---|---|---|---|
| WIRB-20052717 | OTHER | Western Insitutional Review Board | None |
| SCCC-2005141 | OTHER | None | None |