NCT00564720

Brief 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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
140

participants targeted

Target at P75+ for phase_2 pancreatic-cancer

Timeline
Completed

Started Dec 2006

Typical duration for phase_2 pancreatic-cancer

Geographic Reach
1 country

8 active sites

Status
terminated

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

December 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 27, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 28, 2007

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

February 15, 2013

Status Verified

February 1, 2013

Enrollment Period

4.2 years

First QC Date

November 27, 2007

Last Update Submit

February 14, 2013

Conditions

Pancreatic Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Survival

    1 year survival

Secondary Outcomes (4)

  • Progression free interval

    1 year

  • Response rate

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

  • Toxicity profile

    Toxicity assessment on each chemotherapy cycle

  • Symptoms improvement

    Assessment every two cycles

Study Arms (2)

1

EXPERIMENTAL

GEM/TAR

Drug: GemcitabineDrug: Erlotinib

2

EXPERIMENTAL

GEM/OX/TAR

Drug: GemcitabineDrug: ErlotinibDrug: Oxaliplatin

Interventions

GemcitabineDRUG

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

Also known as: Gemzar
1
ErlotinibDRUG

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

Also known as: Tarceva
12
OxaliplatinDRUG

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

Also known as: Eloxatin
2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

University General Hospital of Alexandroupolis, Department of Medical Oncology

Alexandroupoli, Greece

Location

Air Forces Military Hospital of Athens

Athens, Greece

Location

Errikos Ntynan General Hospital

Athens, Greece

Location

IASO General Hospital of Athens, 1st Department of Medical Oncology

Athens, Greece

Location

Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine

Athens, Greece

Location

Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology

Athens, Greece

Location

State General Hospital of Larissa

Larissa, Greece

Location

Diabalkaniko General Hospital of Thessaloniki

Thessaloniki, Greece

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineErlotinib HydrochlorideOxaliplatin

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-RingCoordination ComplexesOrganic Chemicals

Study Officials

  • Vassilis Georgoulias, MD

    University Hospital of Crete, Dep of Medical Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 27, 2007

First Posted

November 28, 2007

Study Start

December 1, 2006

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

February 15, 2013

Record last verified: 2013-02

Locations

GR(8)