NCT00728000

Phase II Study Of Neoadjuvant Chemotherapy In Borderline Resectable Pancreatic Adenocarcinoma

Phase II Study Of Neoadjuvant Chemotherapy With Gemcitabine, Oxaliplatin And Erlotinib (Gemoxt) In Borderline Resectable Pancreatic Adenocarcinoma

• Status: Withdrawn
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University of Cincinnati · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to determine the effect of chemotherapy on decreasing the size of unresectable pancreas cancer thereby allowing it to be surgically removed. In addition, this study may provide information on how tumors behave when exposed to certain types of chemotherapy.

Detailed description

Although surgery is the only curative modality for pancreatic adenocarcinoma, the majority of patients (\~80%)are unresectable at presentation. The use of a multimodality approach may be a crucial method to improve the dismal survival rate of patients with pancreatic cancer. A logical tactic is to use neoadjuvant cytotoxic agents and targeted drugs to facilitate resectability.

Conditions

• Pancreatic Adenocarcinoma

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000mg/m2 IV on day 1 and day 15 over 30mins.
DRUG	Oxaliplatin	100mg/m2 IV on days 1 and 15 given over 120 mins.
DRUG	Erlotinib	100mg/day PO on days 1-14 and 15-28

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-08-01
• Completion: 2010-08-01
• First posted: 2008-08-05
• Last updated: 2019-11-25

Locations

1 site across 1 country: United States