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.
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
Universitätsmedizin Berlin🇩🇪Berlin, Germany