NCT00919282

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: CONKO-Studiengruppe · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metastatic Pancreatic Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine, folinic acid, 5-FU	gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours

Timeline

• Start date: 1997-09-01
• Primary completion: 2000-07-01
• Completion: 2002-12-01
• First posted: 2009-06-12
• Last updated: 2009-06-12

Locations

1 site across 1 country: Germany