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

Primary Purpose

Metastatic Pancreatic Cancer

Status

Unknown status

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Erlotinib

About this trial

This is an interventional treatment trial for Metastatic Pancreatic Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Division of Gastroenterology, Taipei Veterans General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Gemcitabine

Gemcitabine plus erlotinib

Arm Description

Outcomes

Primary Outcome Measures

disease control rate

Secondary Outcome Measures

response rate

overall survival

progression-free survival

Full Information

NCT ID

NCT01608841

First Posted

May 28, 2012

Last Updated

February 14, 2015

Sponsor

Taipei Veterans General Hospital, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT01608841

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Unknown status

Study Start Date

July 2005 (undefined)

Primary Completion Date

October 2015 (Anticipated)

Study Completion Date

October 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Taipei Veterans General Hospital, Taiwan

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Metastatic Pancreatic Cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

88 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gemcitabine

Arm Type

No Intervention

Arm Title

Gemcitabine plus erlotinib

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Erlotinib

Other Intervention Name(s)

Tarceva

Intervention Description

Erlotinib 100 mg 1# PO qd till disease progression

Primary Outcome Measure Information:

Title

disease control rate

Time Frame

eight weeks

Secondary Outcome Measure Information:

Title

response rate

Time Frame

eight weeks

Title

overall survival

Time Frame

one day

Title

progression-free survival

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Chung-Pin Li, MD

Phone

+886-2-28757506

cpli@vghtpe.gov.tw

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Chung-Pin Li, MD, PhD

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Yee Chao, MD,PhD

Organizational Affiliation

Taipei Veterans General Hospital, Taiwan

Official's Role

Study Director

Facility Information:

Facility Name

Division of Gastroenterology, Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Chung-Pin Li, MD

Phone

+886-2-28757506

cpli@vghtpe.gov.tw

First Name & Middle Initial & Last Name & Degree

Chung-Pin Li, MD

12. IPD Sharing Statement

Citations:

PubMed Identifier

26046796

Citation

Wang JP, Wu CY, Yeh YC, Shyr YM, Wu YY, Kuo CY, Hung YP, Chen MH, Lee WP, Luo JC, Chao Y, Li CP. Erlotinib is effective in pancreatic cancer with epidermal growth factor receptor mutations: a randomized, open-label, prospective trial. Oncotarget. 2015 Jul 20;6(20):18162-73. doi: 10.18632/oncotarget.4216.

Results Reference

derived

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

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