The Role of EGFR Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

February 14, 2015 updated by: vghtpe user, Taipei Veterans General Hospital, Taiwan

The Role of Epidermal Growth Factor Receptor (EGFR) Mutations in Pancreatic Cancer Patients Receiving Gemcitabine With or Without Erlotinib

The purpose of this study is to investigate the influence of epidermal growth factor receptor mutations on the efficacy of erlotinib and gemcitabine in metastatic pancreatic cancer.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The influence of EGFR mutations on the efficacy of treatment with and without erlotinib in metastatic pancreatic cancer is to be determined.

Study Type

Interventional

Enrollment (Anticipated)

88

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

  • Taiwan
      • Taipei, Taiwan, 11217
        • Recruiting
        • Division of Gastroenterology, Taipei Veterans General Hospital
        • Contact:
        • Principal Investigator:
          • Chung-Pin Li, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • metastatic chemotherapy-naïve pancreatic cancer patients
  • histologically confirmed
  • adequate samples for analysis
  • Eastern Cooperative Oncology Group (ECOG) performance status <= 2
  • absolute neutrophil count (ANC) >= 1,500/mm3
  • platelet count >= 100,000/mm3
  • serum creatinine <= 1.5 mg/dL
  • aspartate aminotransferase (AST)
  • alanine aminotransferase (ALT) < 5 times the upper limit of normal

Exclusion Criteria:

  • absence of any other malignancy or serious medical or psychological illness that would preclude informed consent

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: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Gemcitabine
Experimental: Gemcitabine plus erlotinib
Drug: Erlotinib
Erlotinib 100 mg 1# PO qd till disease progression
Other Names:
  • Tarceva

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
disease control rate
Time Frame: eight weeks
eight weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
response rate
Time Frame: eight weeks
eight weeks
overall survival
Time Frame: one day
one day
progression-free survival
Time Frame: one day
one day

Collaborators and Investigators

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

Sponsor

Taipei Veterans General Hospital, Taiwan

Investigators

  • Principal Investigator: Chung-Pin Li, MD, PhD, Taipei Veterans General Hospital, Taiwan
  • Study Director: Yee Chao, MD,PhD, Taipei Veterans General Hospital, Taiwan

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

July 1, 2005

Primary Completion (Anticipated)

October 1, 2015

Study Completion (Anticipated)

October 1, 2015

Study Registration Dates

First Submitted

May 28, 2012

First Submitted That Met QC Criteria

May 30, 2012

First Posted (Estimate)

May 31, 2012

Study Record Updates

Last Update Posted (Estimate)

February 18, 2015

Last Update Submitted That Met QC Criteria

February 14, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 98-01-34A

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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