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

Taipei Veterans General Hospital, Taiwan88 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Metastatic Pancreatic Cancer

Interventions

ErlotinibDRUG

Erlotinib 100 mg 1# PO qd till disease progression

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Division of Gastroenterology, Taipei Veterans General Hospital

Taipei, Taiwan, Taiwan

RECRUITING

Outcomes

Primary Outcomes

disease control rate

Time frame: eight weeks

Secondary Outcomes

response rate

Time frame: eight weeks

overall survival

Time frame: one day

progression-free survival

Time frame: one day

Central Contacts

Chung-Pin Li, MD

CONTACT

+886-2-28757506 cpli@vghtpe.gov.tw

Data from ClinicalTrials.gov

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