Ignite Creation Date:
2024-05-05 @ 5:12 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00408564
Status:
COMPLETED
Last Update Posted:
2018-07-23
First Post:
2006-12-06
Brief Title:
Cetuximab Gemcitabine and Oxaliplatin Followed By Surgery or External-Beam Radiation Therapy and Capecitabine in Treating Patients With Locally Advanced Nonmetastatic Pancreatic Cancer That Cannot Be Removed By Surgery
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Phase II Study of Neoadjuvant GemcitabineOxaliplatin and Cetuximab Followed by Surgery or Concurrent External Beam Radiation With Capecitabine for Patients With Locally Advanced Unresectable Nonmetastatic Pancreatic Cancer
Status:
COMPLETED
Status Verified Date:
2018-05
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 Drugs used in chemotherapy such as gemcitabine oxaliplatin and capecitabine work in different ways to stop the growth of tumor cells either by killing the cells or by stopping them from dividing Sometimes when chemotherapy is given it does not stop the growth of tumor cells The tumor is said to be resistant to chemotherapy Giving cetuximab together with chemotherapy may reduce drug resistance and allow the tumor cells to be killed Giving cetuximab and chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed Radiation therapy uses high-energy x-rays to kill tumor cells
PURPOSE This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced nonmetastatic pancreatic cancer that cannot be removed by surgery
PURPOSE This phase II trial is studying how well giving cetuximab together with oxaliplatin and gemcitabine followed by surgery or external-beam radiation therapy and capecitabine works in treating patients with locally advanced nonmetastatic pancreatic cancer that cannot be removed by surgery
Detailed Description:
OBJECTIVES
Primary
Determine the progression-free survival rate in patients with unresectable locally advanced nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy comprising cetuximab gemcitabine hydrochloride and oxaliplatin followed by either surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine
Secondary
Determine the toxicity and tolerability of this regimen in these patients
Determine overall survival and progression-free survival
Determine the response rate in these patients
Determine the response duration defined as the time from first observation response to the time of progressive disease in patients who achieve at least a partial response to treatment
Determine the biomarker response of CA19-9
OUTLINE This is an open-label study
Neoadjuvant therapy 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 hours on day 2 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are evaluated after completion of neoadjuvant therapy Patients with metastatic disease are taken off study Beginning within 4 weeks after completion of neoadjuvant therapy patients with resectable disease proceed to surgical resection or chemoradiotherapy by choice patients with unresectable disease proceed to chemoradiotherapy
Surgery Patients undergo surgical resection with the Whipple procedure
Chemoradiotherapy Patients receive oral capecitabine twice daily 5 days a week on days 1-5 and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks
After completion of study treatment patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 42 patients will be accrued for this study
Primary
Determine the progression-free survival rate in patients with unresectable locally advanced nonmetastatic adenocarcinoma of the pancreas treated with neoadjuvant therapy comprising cetuximab gemcitabine hydrochloride and oxaliplatin followed by either surgery or chemoradiotherapy comprising external-beam radiotherapy and capecitabine
Secondary
Determine the toxicity and tolerability of this regimen in these patients
Determine overall survival and progression-free survival
Determine the response rate in these patients
Determine the response duration defined as the time from first observation response to the time of progressive disease in patients who achieve at least a partial response to treatment
Determine the biomarker response of CA19-9
OUTLINE This is an open-label study
Neoadjuvant therapy 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 hours on day 2 Treatment repeats every 2 weeks for 6 courses in the absence of disease progression or unacceptable toxicity
Patients are evaluated after completion of neoadjuvant therapy Patients with metastatic disease are taken off study Beginning within 4 weeks after completion of neoadjuvant therapy patients with resectable disease proceed to surgical resection or chemoradiotherapy by choice patients with unresectable disease proceed to chemoradiotherapy
Surgery Patients undergo surgical resection with the Whipple procedure
Chemoradiotherapy Patients receive oral capecitabine twice daily 5 days a week on days 1-5 and undergo external-beam radiotherapy once daily 5 days a week for 5½ weeks
After completion of study treatment patients are followed every 3 months for 1 year
PROJECTED ACCRUAL A total of 42 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 |
|---|---|---|---|
| SANOFI-MUSC-100918 | None | None | None |
| MUSC-100918 | None | None | None |
| BMS-MUSC-100918 | None | None | None |