NCT00564720

Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 140 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Gemcitabine	Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
DRUG	Gemcitabine	Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
DRUG	Erlotinib	Erlotinib 100 mg by mouth (p.o.), daily until disease progression
DRUG	Oxaliplatin	Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

Timeline

• Start date: 2006-12-01
• Primary completion: 2011-03-01
• Completion: 2011-03-01
• First posted: 2007-11-28
• Last updated: 2013-02-15

Locations

8 sites across 1 country: Greece