Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Pancreatic Cancer - Full Text View

Sponsors and Collaborators:	Hellenic Oncology Research Group University Hospital of Crete
Information provided by:	Hellenic Oncology Research Group
ClinicalTrials.gov Identifier:	NCT00564720

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 II

MedlinePlus related topics: Cancer Pancreatic Cancer

Drug Information available for: Gemcitabine hydrochloride Gemcitabine Erlotinib Erlotinib hydrochloride Oxaliplatin

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Phase II Study of Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in Patients With Locally Advanced or Metastatic Pancreatic Cancer

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 ]

Estimated Enrollment:	256
Study Start Date:	December 2006
Estimated Study Completion Date:	December 2009
Estimated Primary Completion Date:	December 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental GEM/TAR	Drug: Gemcitabine Gemcitabine 1000mg/m2 IV on days 1, 8, and 15 every 28 days for 6 cycles Drug: Erlotinib Erlotinib 100 mg by mouth (p.o.), daily until disease progression
2: Experimental GEM/OX/TAR	Drug: Gemcitabine Gemcitabine 1100 mg/m2 IV on days 1 and 8 every 21 days for 6 cycles Drug: Erlotinib Erlotinib 100 mg by mouth (p.o.), daily until disease progression Drug: Oxaliplatin Oxaliplatin 130 mg/m2 IV on day 8, every 21 days for 6 cycles

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

Contacts

Contact: Dora Hatzidaki	+302810392570	dorachat@med.uoc.gr
Contact: Eua Maragkoudaki	+302810392987

Locations

Greece
Laikon General Hospital, Medical Oncology Unit, Propedeutic Department of Internal Medicine	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Aris Polyzos, MD
Errikos Ntynan General Hospital	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: George Stathopoulos, MD
University General Hospital of Alexandroupolis, Department of Medical Oncology	Recruiting
Alexandroupolis, Greece
Contact: Dora Hatzidaki +302810392570 dorachat@med.uoc.gr
Contact: Eua Maragkoudaki +302810392987 dhatzidaki@yahoo.com
Principal Investigator: Stelios Kakolyris, MD
IASO General Hospital of Athens, 1st Department of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Stelios Giassas, MD
Diabalkaniko General Hospital of Thessaloniki	Recruiting
Thessaloniki, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Christos Emmanouilidis, MD
Air Forces Military Hospital of Athens	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Kentepozidis, MD
State General Hospital of Larissa	Recruiting
Larissa, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Athanasios Athanasiadis, MD
Metaxa's Anticancer Hospital of Piraeus, 1st Department of Medical Oncology	Recruiting
Athens, Greece
Contact: Nikoleta Karkatzou, MD +302106448666 secretary@horg.gr
Contact: Spyros Georgiadis +302106457968 secretary@horg.gr
Principal Investigator: Nikos Ziras, MD

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

Responsible Party:	Hellenic Oncology Research Group ( V.Georgoulias )
Study ID Numbers:	CT/06.13
Study First Received:	November 27, 2007
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00564720
Health Authority:	Greece: National Organization of Medicines

Study placed in the following topic categories:

Erlotinib
Oxaliplatin
Digestive System Diseases
Digestive System Neoplasms
Pancreatic Neoplasms
Endocrine System Diseases

Pancreatic Diseases
Gastrointestinal Neoplasms
Endocrinopathy
Gemcitabine
Endocrine Gland Neoplasms

Additional relevant MeSH terms:

Antimetabolites
Anti-Infective Agents
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Immunologic Factors
Antineoplastic Agents
Physiological Effects of Drugs
Enzyme Inhibitors

Protein Kinase Inhibitors
Antiviral Agents
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Radiation-Sensitizing Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on January 15, 2009