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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)
Sponsor:
Collaborator:
University Hospital of Crete
Information provided by (Responsible Party):
Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:
NCT00564720
First received: November 27, 2007
Last updated: February 14, 2013
Last verified: February 2013
History of Changes
  Purpose

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
Endpoint Classification: Efficacy Study
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:

U.S. FDA Resources

Further study details as provided by Hellenic Oncology Research Group:

Primary Outcome Measures:
  • Overall Survival [ Time Frame: 1 year survival ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression free interval [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Response rate [ Time Frame: Objective responses confirmed by CT or MRI on 3rd and 6th cycle ] [ Designated as safety issue: No ]
  • Toxicity profile [ Time Frame: Toxicity assessment on each chemotherapy cycle ] [ Designated as safety issue: Yes ]
  • Symptoms improvement [ Time Frame: Assessment every two cycles ] [ Designated as safety issue: No ]

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
GEM/TAR
 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
GEM/OX/TAR
 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00564720

Locations
Greece
University General Hospital of Alexandroupolis, Department of Medical Oncology
Alexandroupolis, Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine
Athens, Greece
Errikos Ntynan General Hospital
Athens, Greece
IASO General Hospital of Athens, 1st Department of Medical Oncology
Athens, Greece
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology
Athens, Greece
Air Forces Military Hospital of Athens
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
Investigators
Principal Investigator: Vassilis Georgoulias, MD University Hospital of Crete, Dep of Medical Oncology
  More Information

No publications provided

Responsible Party: Hellenic Oncology Research Group
ClinicalTrials.gov Identifier: NCT00564720     History of Changes
Other Study ID Numbers: CT/06.13
Study First Received: November 27, 2007
Last Updated: February 14, 2013
Health Authority: Greece: National Organization of Medicines

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Gemcitabine
Erlotinib
Oxaliplatin
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Protein Kinase Inhibitors

ClinicalTrials.gov processed this record on May 22, 2013