NCT00871169

Combination of Irinotecan, Oxaliplatin and Cetuximab for Locally Advanced or Metastatic Pancreatic Cancer

INST 0802: Phase II Trial of Combination Irinotecan, Oxaliplatin and Cetuximab for Patients With Locally Advanced or Metastatic Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: New Mexico Cancer Research Alliance · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase II trial studies the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.

Detailed description

The investigators will evaluate the side effects and how well irinotecan hydrochloride, oxaliplatin and cetuximab work in treating patients with unresectable or metastatic pancreatic cancer. Irinotecan hydrochloride may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Drugs used in chemotherapy, such as oxaliplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as cetuximab, can block tumor growth in different ways. Some block the ability of tumor to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving irinotecan hydrochloride together with oxaliplatin and cetuximab may kill more tumor cells.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Irinotecan, oxaliplatin, and cetuximab	Irinotecan at 90 mg/m2 intravenously every two weeks (administered over 60 minutes) + Oxaliplatin at 60 mg/m2 intravenously every two weeks(administered over 60 minutes) + Cetuximab at 250 mg/m2 intravenously every two weeks (administered over 90 minutes). The treatment interval (one cycle) is every 14 days.

Timeline

• Start date: 2008-10-01
• Primary completion: 2015-04-01
• Completion: 2015-04-01
• First posted: 2009-03-30
• Last updated: 2016-06-14
• Results posted: 2016-06-14

Locations

5 sites across 1 country: United States