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

Metastatic Pancreatic Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01608841
• Other study ID #: 98-01-34A
• Status: Recruiting
• Phase: Phase 2
• First received: May 28, 2012
• Last updated: February 14, 2015
• Start date: July 2005
• Est. completion date: October 2015

Study information

• Verified date: February 2015
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Chung-Pin Li, MD
• Phone: +886-2-28757506
• Email: cpli[@]vghtpe.gov.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 88
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Metastatic Pancreatic Cancer
• Pancreatic Neoplasms

Intervention

Drug:
• Erlotinib
Erlotinib 100 mg 1# PO qd till disease progression

Locations

Country	Name	City	State
Taiwan	Division of Gastroenterology, Taipei Veterans General Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	disease control rate		eight weeks	Yes
Secondary	response rate		eight weeks	Yes
Secondary	overall survival		one day	Yes
Secondary	progression-free survival		one day	Yes