NCT00326911

Cetuximab and Bevacizumab With or Without Gemcitabine to Treat Metastatic Pancreatic Cancer

A Phase II, Randomized, Open-Label Study of Cetuximab and Bevacizumab Alone or in Combination With Fixed-Dose Rate Gemcitabine as First-Line Therapy of Patients With Metastatic Adenocarcinoma of the Pancreas

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: Eli Lilly and Company · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Eligible patients with metastatic pancreatic cancer will be treated with dual agent monoclonal antibody consisting of cetuximab and bevacizumab alone or in combination with gemcitabine

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
BIOLOGICAL	cetuximab	I.V. infusion of 400 mg/m2 (over 120 minutes) on day 1 of cycle 1
BIOLOGICAL	bevacizumab	10 mg/kg (over 60 minutes) on day 1 and repeated every 2 weeks.
DRUG	gemcitabine	1000 mg/m2 administered intravenously at 10 mg/m2/minute over 100 minutes weekly x 3 of 4 weeks.
BIOLOGICAL	cetuximab	I.V.infusions of 250 mg/m2 (over 60 minutes) weekly

Timeline

• Start date: 2006-05-01
• Primary completion: 2008-10-01
• Completion: 2008-12-01
• First posted: 2006-05-17
• Last updated: 2011-05-25
• Results posted: 2009-12-04

Locations

16 sites across 1 country: United States