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

February 14, 2013 updated by: Hellenic Oncology Research Group

Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Greece
      • Alexandroupolis, Greece
        • University General Hospital of Alexandroupolis, Department of Medical Oncology
      • Athens, 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
      • Larissa, Greece
        • State General Hospital of Larissa
      • Thessaloniki, Greece
        • Diabalkaniko General Hospital of Thessaloniki

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
GEM/TAR
Drug: Gemcitabine
Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
Other Names:
  • Gemzar
Drug: Gemcitabine
Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
Other Names:
  • Gemzar
Drug: Erlotinib
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
Other Names:
  • Tarceva
Experimental: 2
GEM/OX/TAR
Drug: Gemcitabine
Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
Other Names:
  • Gemzar
Drug: Gemcitabine
Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
Other Names:
  • Gemzar
Drug: Erlotinib
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
Other Names:
  • Tarceva
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
Other Names:
  • Eloxatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Overall Survival
Time Frame: 1 year survival
1 year survival

Secondary Outcome Measures

Outcome Measure
Time Frame
Toxicity profile
Time Frame: Toxicity assessment on each chemotherapy cycle
Toxicity assessment on each chemotherapy cycle
Progression free interval
Time Frame: 1 year
1 year
Response rate
Time Frame: Objective responses confirmed by CT or MRI on 3rd and 6th cycle
Objective responses confirmed by CT or MRI on 3rd and 6th cycle
Symptoms improvement
Time Frame: Assessment every two cycles
Assessment every two cycles

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hellenic Oncology Research Group

Collaborators

University Hospital of Crete

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2006

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

November 27, 2007

First Submitted That Met QC Criteria

November 27, 2007

First Posted (Estimate)

November 28, 2007

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 14, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CT/06.13

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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