Trial of Erlotinib, Gemcitabine and Cisplatin in Metastatic Pancreatic Cancer

Gyeongsang National University Hospital22 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Pancreatic Cancer

Interventions

Gemcitabine, Cisplatin, Erlotinib (Tarceva)DRUG

* 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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (3)

Dong-A University Hospital

Busan, South Korea

Gyeongsang Unversity Hospital

Jinju, South Korea

Chung-Ang University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

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

Data from ClinicalTrials.gov

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