Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

November 18, 2012 updated by: Jung Hun Kang, Gyeongsang National University Hospital

A Phase II Trial of Erlotinib in Combination With Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Busan, Korea, Republic of, 602-715
        • Dong-A University Hospital
      • JinJU, Korea, Republic of
        • Gyeongsang Unversity Hospital
      • Seoul, Korea, Republic of, 156-755
        • Chung-Ang University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GPE
Gemcitabine-Cisplatin-Erlotinib
Drug: Gemcitabine, Cisplatin, Erlotinib (Tarceva)
  • Erlotinib 100 mg po q d daily AND
  • Gemcitabine 1000 mg/m² with 250 mL of normal saline intravenously infusion over 30 mins on Day 1, 8
  • Cisplatin 25 mg/m2 with 150 mL of normal saline intravenously infusion over 60 mins on D1,8

Every 3 weeks

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Gyeongsang National University Hospital

Collaborators

Chung-Ang University Hosptial, Chung-Ang University College of Medicine
Dong-A University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

August 1, 2010

Study Completion (Actual)

May 1, 2011

Study Registration Dates

First Submitted

June 2, 2009

First Submitted That Met QC Criteria

June 16, 2009

First Posted (Estimate)

June 17, 2009

Study Record Updates

Last Update Posted (Estimate)

November 20, 2012

Last Update Submitted That Met QC Criteria

November 18, 2012

Last Verified

November 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Gyeongsang-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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