Gemcitabine (GFF) in Patients With Pancreatic Cancer

CONKO-Studiengruppe

Status and phase: Completed; Phase 2

Conditions: Metastatic Pancreatic Cancer

Treatments: Drug: gemcitabine, folinic acid, 5-FU

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00919282

CONKO 002 pilot

Details and patient eligibility

About

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

Full 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.

Enrollment: 78 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Gemcitabine/folinic acid/5-FU

Experimental group

Description:

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

Treatment:

Drug: gemcitabine, folinic acid, 5-FU