Gemcitabine (GFF) in Patients With Pancreatic Cancer

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919282

Acronym

GFF

Enrollment

Registered

2009-06-12

Start date

1997-09-30

Completion date

2002-12-31

Last updated

2009-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic cancer, gemcitabine, combination

Brief summary

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

Detailed description

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.

Interventions

DRUGgemcitabine, folinic acid, 5-FU

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

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame
overall survival	1 year

Secondary

Measure	Time frame
safety of treatment	1 year

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026