Trial | NCT00919282  Report issue

Title

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.

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    78
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.
Study Started
Sep 30
1997
Primary Completion
Jul 31
2000
Study Completion
Dec 31
2002
Last Update
Jun 12
2009
Estimate

Drug gemcitabine, folinic acid, 5-FU

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

  • Other names: gemzar, oncofolic, 5-fu

Gemcitabine/folinic acid/5-FU Experimental

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

Criteria 

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
No Results Posted