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Completed

NCT Number: NCT00919282

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).

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Key information

Conditions

Metastatic Pancreatic Cancer Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Neoplasms Neoplasms by Site Pancreatic Diseases Pancreatic Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

gemcitabine, folinic acid, 5-FU

Drug

gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours

Other names: gemzar, oncofolic, 5-fu

Primary outcomes

  1. overall survival

    Time frame: 1 year

Secondary outcomes

  1. safety of treatment

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

CONKO-Studiengruppe

Other

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.

Acronym: GFF

Important dates

Study start
1997
Primary completion
2000
Study completion
2002
First posted
Jun 12, 2009
Registry last updated
Jun 12, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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