NCT01693419

Brief Summary

This study will conduct a phase II study of gemcitabine, erlotinib, and S-1 as first-line chemotherapy in patients with advanced pancreatic cancer and evaluate the EGFR expression, KRAS mutation, and BRAF mutation as predictive or prognostic markers

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 20, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 26, 2012

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 23, 2017

Status Verified

August 1, 2017

Enrollment Period

5.3 years

First QC Date

September 20, 2012

Last Update Submit

August 22, 2017

Conditions

Pancreas Neoplasms

Keywords

pancreas neoplasmgemcitabineerlotinibS-1

Outcome Measures

Primary Outcomes (1)

  • Objective response rate

    Objective response rate will be measured from the rate of complete response (disappearance of disease) and partial response (decrease at least 30% in the sum of the longest diameters of target lesions) by RECIST (response evaluation criteria in solid tumors) guidelines.

    1.5 years

Secondary Outcomes (4)

  • Progression free survival

    1.5 years

  • Overall survival

    1.5 years

  • Disease control rate

    1.5 years

  • Toxicity profiles

    1.5 years

Study Arms (1)

GES (Gemcitabine, Erlotinib, S-1)

EXPERIMENTAL

Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m² IV on day 1, 8 2. Erlotinib 100 mg/day PO on day 1 3. S-1 60 mg/m²/day PO on day 1-14

Drug: GES (Gemcitabine, Erlotinib, S-1)

Interventions

GES (Gemcitabine, Erlotinib, S-1)DRUG

Treatment will be delivered as a 3-week cycle. 1. Gemcitabine 1000 mg/m² IV on day 1, 8 2. Erlotinib 100 mg/day PO on day 1 3. S-1 60 mg/m²/day PO on day 1-14

Also known as: Gemzar, Tarceva, TS-1
GES (Gemcitabine, Erlotinib, S-1)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed locally advanced unresectable, recurrent or metastatic adenocarcinoma of pancreas (Stage III-IV ; TNM staging system)
  • Measurable or evaluable disease by RECIST criteria 1.1
  • Minimum age of 18 years
  • ECOG Performance status 0-1
  • Prior adjuvant chemotherapy without gemcitabine, erlotinib or S-1 is allowed if more than 4 weeks elapsed since completion of chemotherapy.
  • More than 4 weeks since completion of prior radiotherapy (measurable or evaluable lesions should be outside the radiation field)
  • Adequate organ functions
  • Patients must sign an informed consent indicating that they are aware of the investigational nature of the study in keeping with the policy of the hospital.

You may not qualify if:

  • Patients treated previously with gemcitabine, erlotinib, or S-1 as adjuvant chemotherapy.
  • Patients with CNS metastases
  • Patients with active infection, severe heart disease, uncontrollable hypertension or diabetes mellitus, myocardial infarction during the preceding 6 months, pregnancy, or breast feeding
  • Any previous or concurrent malignancy other than non-melanoma skin cancer or in situ cancer of uterine cervix
  • Known history of cerebral or leptomeningeal metastases or neurologic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hallym University Medical Center

Anyang, South Korea

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineErlotinib HydrochlorideS 1 (combination)titanium silicide

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingQuinazolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Dae Young Zang, DM, PhD

    Hallym University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2012

First Posted

September 26, 2012

Study Start

August 1, 2011

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

August 23, 2017

Record last verified: 2017-08

Locations

KR(1)