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TerminatedNCT00564720Updated Feb 15, 2013

Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer

A Phase 2 interventional study of Gemcitabine and Gemcitabine in Pancreatic Cancer, sponsored by Hellenic Oncology Research Group. Terminated at 8 sites in Greece. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2013-02-15.

Sponsored by Hellenic Oncology Research Group · Phase 2, Interventional, and Treatment

Why this study was terminated
Due to poor accrual of the study
Phase
Phase 2
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This randomized phase II trial will compare the efficacy and toxicity of Gemcitabine plus Erlotinib versus Gemcitabine plus Erlotinib plus Oxaliplatin in patients with pancreatic cancer.

02

Conditions studied

  • Pancreatic Cancer
03

In context

Pancreatic Neoplasms

3,235 studies on the registry are indexed under Pancreatic Neoplasms; 898 are open to participants now.

This study's enrollment of 140 is above the median of 46 across 2,424 interventional studies indexed under Pancreatic Neoplasms.

Browse Pancreatic Neoplasms studies →

Lead sponsor

Hellenic Oncology Research Group is the lead sponsor of 57 studies on the registry; none are open to participants now.

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

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Histologically confirmed pancreatic cancer.
  • Measurable disease.
  • Absence of ascites or obstructive jaundice.
  • ECOG Performance Status 0-2.
  • Adequate liver kidney and bone marrow function.
  • Written informed consent.

Exclusion criteria

Exclusion Criteria:

  • Chronic diarrheic syndrome.
  • Uncontrolled brain metastases after radiation.
  • Liver infiltration over 50%.
  • Peripheral neuropathy ≥ 2.
  • No second primary malignancy within the past 5 years, except non-melanomas skin cancer or in situ carcinoma of the cervix.
  • No active uncontrolled infection.
  • Active cardiac disease : unstable angina or onset of angina within last 3 months, myocardial infarction within 6 months, congestive heart failure > class II, cardiac ventricular arrhythmias requiring anti-arrhythmic therapy.
  • Women who are pregnant or lactating.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (actual)

Study arms

  • Experimental
    1

    GEM/TAR

    Drug: Gemcitabine · Drug: Erlotinib

  • Experimental
    2

    GEM/OX/TAR

    Drug: Gemcitabine · Drug: Erlotinib · Drug: Oxaliplatin

Interventions

  • DrugGemcitabine

    Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles

    Also known as: Gemzar

  • DrugGemcitabine

    Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles

    Also known as: Gemzar

  • DrugErlotinib

    Erlotinib 100 mg by mouth (p.o.), daily until disease progression

    Also known as: Tarceva

  • DrugOxaliplatin

    Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

    Also known as: Eloxatin

06

What researchers measure

Primary outcomes

  1. Overall Survival

    Time frame: 1 year survival

Secondary outcomes

  1. Progression free interval

    Time frame: 1 year

  2. Response rate

    Time frame: Objective responses confirmed by CT or MRI on 3rd and 6th cycle

  3. Toxicity profile

    Time frame: Toxicity assessment on each chemotherapy cycle

  4. Symptoms improvement

    Time frame: Assessment every two cycles

07

Study locations

8 sites
  • University General Hospital of Alexandroupolis, Department of Medical Oncology
    Alexandroupolis, Greece
  • Air Forces Military Hospital of Athens
    Athens, Greece
  • Errikos Ntynan General Hospital
    Athens, Greece
  • IASO General Hospital of Athens, 1st Department of Medical Oncology
    Athens, Greece
  • Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
    Athens, Greece
  • Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
    Athens, Greece
  • State General Hospital of Larissa
    Larissa, Greece
  • Diabalkaniko General Hospital of Thessaloniki
    Thessaloniki, Greece
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00564720
Lead sponsor
Hellenic Oncology Research Group
Collaborators
University Hospital of Crete
Responsible party
Sponsor
First posted
Nov 28, 2007
Start date
Dec 2006
Primary completion
Mar 2011
Completion
Mar 2011
Last update
Feb 15, 2013

Study contacts

Vassilis Georgoulias, MD
principal investigator · University Hospital of Crete, Dep of Medical Oncology

Oversight

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

Not currently enrolling

This study is terminated, as verified in Feb 2013. You cannot join it, but the record below documents what was studied.

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