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

This study has been terminated.
(Due to poor accrual of the study)
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group Identifier:
First received: November 27, 2007
Last updated: February 14, 2013
Last verified: February 2013
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.

Condition Intervention Phase
Pancreatic Cancer
Drug: Gemcitabine
Drug: Erlotinib
Drug: Oxaliplatin
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

Resource links provided by NLM:

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 year survival ]

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

Enrollment: 140
Study Start Date: December 2006
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Drug: Gemcitabine
Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles
Other Name: Gemzar
Drug: Erlotinib
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
Other Name: Tarceva
Experimental: 2
Drug: Gemcitabine
Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles
Other Name: Gemzar
Drug: Erlotinib
Erlotinib 100 mg by mouth (p.o.), daily until disease progression
Other Name: Tarceva
Drug: Oxaliplatin
Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles
Other Name: Eloxatin


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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.
  Contacts and Locations
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Please refer to this study by its identifier: NCT00564720

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
Sponsors and Collaborators
Hellenic Oncology Research Group
University Hospital of Crete
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

Responsible Party: Hellenic Oncology Research Group Identifier: NCT00564720     History of Changes
Other Study ID Numbers: CT/06.13
Study First Received: November 27, 2007
Last Updated: February 14, 2013

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Erlotinib Hydrochloride
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protein Kinase Inhibitors processed this record on April 27, 2017