NCT01505413

Phase 2 Study of Erlotinib, Gemcitabine and Oxaliplatin Combination Chemotherapy to Advanced Pancreatic Cancer

Phase 2 Study of GEMOX-T in Previously Untreated Patients With Advanced Pancreatic Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 33 (actual)
• Sponsor: Soonchunhyang University Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Erlotinib is an orally available, reversible tyrosine kinase inhibitor of epidermal growth factor receptor (EGFR). Association of chemoresistance with the activity of certain tyrosine kinases (e.g. ErbB-1 and Src) has been described for pancreatic cancer and makes a strong case for combining gemcitabine with tyrosine kinase inhibitors. In a phase III trial, the addition of erlotinib to gemcitabine improved survival compared with gemcitabine alone in advanced pancreatic cancer (MJ Moor et al). Also, gemcitabine in combination with oxaliplatin is superior to gemcitabine alone in terms of progression free survival and response rate in one phase III trial (Louvet et al). Taken together, combining erlotinib with gemcitabine and oxaliplatin may further improve the overall survival and clinical benefit of advanced pancreatic cancer.

Detailed description

Open, uncontrolled, multicenter, phase II study This study will enroll previous chemo-naïve patients with locally advanced unresectable or metastatic pancreatic cancer. Study regimen: * Erlotinib 100 mg po qd daily AND * Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1 * Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2 Every 2 weeks Each two weeks is a cycle. If at end of 12 cycles response continues, will administer Gemcitabine and erlotinib until progression.

Conditions

• Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	Erlotinib	Erlotinib 100 mg po qd daily
DRUG	Gemcitabine	Gemcitabine 1000 mg/m² with 150mL of normal saline intravenously infusion over 100min on Day 1
DRUG	Oxaliplatin	Oxaliplatin 100 mg/m2 with 500mL of 5DW intravenously a 2-hour infusion on D2

Timeline

• Start date: 2011-01-01
• Primary completion: 2013-12-01
• Completion: 2014-03-01
• First posted: 2012-01-06
• Last updated: 2014-04-03

Locations

1 site across 1 country: South Korea