Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)

• Registration Number: NCT00922896
• Lead Sponsor: Gyeongsang National University Hospital

Brief Summary

The purpose of this study is to determine the response rate of gemcitabine, cisplatin and erlotinib in metastatic pancreatic cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-02
• Study First Submitted QC: 2009-06-16
• Study First Posted: 2009-06-17
• Primary Completion: 2010-08
• Study Completion: 2011-05
• Status Verified: 2012-11
• Last Update Submitted: 2012-11-18
• Last Update Posted: 2012-11-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Age older than 18
• Younger than 75
• ECOG performance status 0 or 1
• Histologically confirmed adenocarcinoma of the pancreas
• Metastatic pancreatic cancer
• No prior chemotherapy for metastatic pancreatic cancer
• A patient with at least one measurable primary lesion of which the diameter is confirmed to be 10mm in Spiral CT or multidetector CT (MD CT)

Exclusion Criteria

• A patient with no measurable disease
• A patient who received previous palliative chemotherapy for pancreatic cancer
• A patient with locally advanced pancreatic cancer
• A patient who received adjuvant chemotherapy for pancreatic cancer within 1 year
• A patient with previous active or passive immunotherapy
• A pregnant or lactating patient

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GPE	Gemcitabine, Cisplatin, Erlotinib (Tarceva)	Gemcitabine-Cisplatin-Erlotinib

Primary Outcome Measures

Name	Time	Method
To assess the response rate associated with gemcitabine, erlotinib and cisplatin in patients with advanced pancreatic cancer	Clinically assessed every cycle (month) and radiologically assessed every 2 cycles (6 weeks) with CT scan

Trial Locations

Locations (3)

Dong-A University Hospital; 🇰🇷 Busan, Korea, Republic of

Gyeongsang Unversity Hospital; 🇰🇷 JinJU, Korea, Republic of

Chung-Ang University Hospital; 🇰🇷 Seoul, Korea, Republic of