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Gemcitabine (GFF) in Patients With Pancreatic Cancer


1997-09


2000-07


2002-12


78

Study Overview

Gemcitabine (GFF) in Patients With Pancreatic Cancer

The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).

This open-label, multi center phase II study was conducted to investigate the efficacy and safety of the combination of 5-Fluorouracil (5-FU)/folinic acid (FA) plus gemcitabine (GFF) in patients (pts) with advanced pancreatic cancer (APC). We consequently started this study after completing the phase I trial accomplished by our CONKO- study group.

  • Metastatic Pancreatic Cancer
  • DRUG: gemcitabine, folinic acid, 5-FU
  • CONKO 002 pilot

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

2009-06-09  

N/A  

2009-06-11  

2009-06-11  

N/A  

2009-06-12  

2009-06-12  

N/A  

2009-06  

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:
Non Randomized


Interventional Model:
Single Group


Masking:
None


Arms and Interventions

Participant Group/ArmIntervention/Treatment
EXPERIMENTAL: Gemcitabine/folinic acid/5-FU

Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²

DRUG: gemcitabine, folinic acid, 5-FU

  • gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours
Primary Outcome MeasuresMeasure DescriptionTime Frame
overall survival1 year
Secondary Outcome MeasuresMeasure DescriptionTime Frame
safety of treatment1 year

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:

    Inclusion Criteria:

  • histological proved pancreatic cancer
  • inoperable disease
  • informed consent
  • adequate bone marrow reserve

  • Exclusion Criteria:

  • under 18 years
  • brain metastasis
  • lactating woman
  • life expectancy under 3 months

Collaborators and Investigators

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

  • Eli Lilly and Company

  • PRINCIPAL_INVESTIGATOR: helmut oettle, MD, CONKO-Studiengruppe

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