Gemcitabine (GFF) in Patients With Pancreatic Cancer

Phase 2

Completed

• Conditions: Metastatic Pancreatic Cancer
• Interventions: Drug: gemcitabine, folinic acid, 5-FU

• Registration Number: NCT00919282
• Lead Sponsor: CONKO-Studiengruppe

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.

Study Timeline

• Study Start: 1997-09
• Primary Completion: 2000-07
• Study Completion: 2002-12
• Status Verified: 2009-06
• Study First Submitted: 2009-06-09
• Study First Submitted QC: 2009-06-11
• Last Update Submitted: 2009-06-11
• Study First Posted: 2009-06-12
• Last Update Posted: 2009-06-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 78

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Gemcitabine/folinic acid/5-FU	gemcitabine, folinic acid, 5-FU	Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²

Primary Outcome Measures

Name	Time	Method
overall survival	1 year

Secondary Outcome Measures

Name	Time	Method
safety of treatment	1 year

Trial Locations

Locations (1)

Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany