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Status unknownNCT01608841Updated Feb 18, 2015

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

A Phase 2 interventional study of Erlotinib in Metastatic Pancreatic Cancer, sponsored by Taipei Veterans General Hospital, Taiwan. Status unknown at 1 site in Taiwan. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-18.

Sponsored by Taipei Veterans General Hospital, Taiwan · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Feb 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
88
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Metastatic Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 899 are open to participants now.

This study's planned enrollment of 88 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Taipei Veterans General Hospital, Taiwan is the lead sponsor of 325 studies on the registry; 72 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • absence of any other malignancy or serious medical or psychological illness that would preclude informed consent
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
None (open label)
Enrollment
88 participants (estimated)

Study arms

  • No intervention
    Gemcitabine
  • Experimental
    Gemcitabine plus erlotinib

    Drug: Erlotinib

Interventions

  • DrugErlotinib

    Erlotinib 100 mg 1# PO qd till disease progression

    Also known as: Tarceva

06

What researchers measure

Primary outcomes

  1. disease control rate

    Time frame: eight weeks

Secondary outcomes

  1. response rate

    Time frame: eight weeks

  2. overall survival

    Time frame: one day

  3. progression-free survival

    Time frame: one day

07

Study locations

1 of 1 sites recruiting
  • Division of Gastroenterology, Taipei Veterans General Hospital
    Taipei, 11217, Taiwan
    • Chung-Pin Li, MD · Contact · cpli@vghtpe.gov.tw · +886-2-28757506
    • Chung-Pin Li, MD · Principal investigator
    Recruiting
08

References and documents

Publications

  • 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. PubMed 26046796 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 18, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01608841
Lead sponsor
Taipei Veterans General Hospital, Taiwan
Responsible party
vghtpe user (Attending Physician, Taipei Veterans General Hospital, Taiwan) — Principal investigator
First posted
May 31, 2012
Start date
Jul 2005
Primary completion
Oct 2015 (estimated)
Completion
Oct 2015 (estimated)
Last update
Feb 18, 2015

Study contacts

Chung-Pin Li, MD
Contact
cpli@vghtpe.gov.tw
+886-2-28757506
Chung-Pin Li, MD, PhD
principal investigator · Taipei Veterans General Hospital, Taiwan
Yee Chao, MD,PhD
study director · Taipei Veterans General Hospital, Taiwan

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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Discussion

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