Trial Of Erlotinib, Gemcitabine And Cisplatin In Metastatic Pancreatic Cancer

Study Overview

Trial of Erlotinib, 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.

N/A

Metastatic Pancreatic Cancer

DRUG: Gemcitabine, Cisplatin, Erlotinib (Tarceva)

Gyeongsang-001

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2009-06-02	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2012-11-18
First Submitted that Met QC Criteria 2009-06-16	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2012-11-20
First Posted (ESTIMATED) 2009-06-17	Results First Posted N/A	Last Verified 2012-11

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Na

Interventional Model:
Single Group

Masking:
None

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

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

Primary Outcome Measures	Measure Description	Time Frame
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

Secondary Outcome Measures	Measure Description	Time Frame

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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)

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

Collaborators and Investigators

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

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

Investigators

Publications

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

General Publications

Hwang IG, Jang JS, Oh SY, Lee S, Kwon HC, Lee GW, Go S, Kang MH, Cha YJ, Kang JH. A phase II trial of Erlotinib in combination with gemcitabine and cisplatin in advanced pancreatic cancer. Invest New Drugs. 2012 Dec;30(6):2371-6. doi: 10.1007/s10637-012-9792-z.

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Resources

PatientS

Caregivers

Clinical Trial Record