The Role of EGFR Mutations in Pancreatic Cancer Patients... | NCT01608841

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

NCT01608841

Sponsor

Taipei Veterans General Hospital, Taiwan

Status

Unknown status

Last Update Posted

Feb 18, 2015Estimated

Enrollment

88Estimated

Phase

Phase 2

Conditions

Metastatic Pancreatic Cancer

Interventions

Erlotinib

Countries

Taiwan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2005

Primary Completion Date

Oct 2015Estimated

Completion Date

Oct 2015Estimated

First Submitted Date

May 28, 2012

First Submission Date that Met QC Criteria

May 30, 2012

First Posted Date

May 31, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 14, 2015

Last Update Posted Date

Feb 18, 2015Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

vghtpe user, Attending Physician, Taipei Veterans General Hospital, TaiwanPrincipal Investigator

Lead Sponsor

Taipei Veterans General Hospital, TaiwanOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

88Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gemcitabine	No Intervention
Gemcitabine plus erlotinib	Experimental		Drug: Erlotinib

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Erlotinib	Drug	Erlotinib 100 mg 1# PO qd till disease progression	Gemcitabine plus erlotinib

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
disease control rate		eight weeks

Secondary Outcomes

Measure	Description	Time Frame
response rate		eight weeks
overall survival		one day
progression-free survival

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chung-Pin Li, MD	Contact	+886-2-28757506		cpli@vghtpe.gov.tw

Overall Officials

Name	Affiliation	Role
Chung-Pin Li, MD, PhD	Taipei Veterans General Hospital, Taiwan	Principal Investigator
Yee Chao, MD,PhD	Taipei Veterans General Hospital, Taiwan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Division of Gastroenterology, Taipei Veterans General Hospital	Recruiting	Taipei	Taiwan	11217	Taiwan

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26046796	Derived	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.

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

ID	Term
D011799	Quinazolines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring
D006571	Heterocyclic Compounds