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

Study Overview

Gemcitabine Plus Erlotinib Versus Erlotinib Plus Gemcitabine Plus Oxaliplatin, in 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.

N/A

Pancreatic Cancer

DRUG: Gemcitabine
DRUG: Gemcitabine
DRUG: Erlotinib
DRUG: Oxaliplatin

CT/06.13

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 Registration Dates	Results Reporting Dates	Study Record Updates
First Submitted 2007-11-27	Results First Submitted N/A	Last Update Submitted that met QC Criteria 2013-02-14
First Submitted that Met QC Criteria 2007-11-27	Results First Submitted that Met QC Criteria N/A	Last Update Posted (ESTIMATED) 2013-02-15
First Posted (ESTIMATED) 2007-11-28	Results First Posted N/A	Last Verified 2013-02

Study Plan

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

Design Details

Primary Purpose:
Treatment

Allocation:
Randomized

Interventional Model:
Parallel

Masking:
None

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 DRUG: Erlotinib Erlotinib 100 mg by mouth (p.o.), daily until disease progression
EXPERIMENTAL: 2 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

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

DRUG: Erlotinib

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

EXPERIMENTAL: 2

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

Primary Outcome Measures	Measure Description	Time Frame
Overall Survival		1 year survival

Secondary Outcome Measures	Measure Description	Time Frame
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

Contacts and Locations

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

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.

Ages Eligible for Study:
ALL

Sexes Eligible for Study:
18 Years

Accepts Healthy Volunteers:

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.

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.

Collaborators and Investigators

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

University Hospital of Crete

Investigators

PRINCIPAL_INVESTIGATOR: Vassilis Georgoulias, MD, University Hospital of Crete, Dep of Medical Oncology

Publications

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

No publications available

Learn

Resources

PatientS

Caregivers

Clinical Trial Record