NCT00919282
Completed
Phase 2
A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.
CONKO-Studiengruppe1 site in 1 country78 target enrollmentSeptember 1997
ConditionsMetastatic Pancreatic Cancer
Interventionsgemcitabine, folinic acid, 5-FU
Overview
- Phase
- Phase 2
- Intervention
- gemcitabine, folinic acid, 5-FU
- Conditions
- Metastatic Pancreatic Cancer
- Sponsor
- CONKO-Studiengruppe
- Enrollment
- 78
- Locations
- 1
- Primary Endpoint
- overall survival
- Status
- Completed
- Last Updated
- 16 years ago
Overview
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.
Investigators
Eligibility 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
Arms & Interventions
Gemcitabine/folinic acid/5-FU
Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²
Intervention: gemcitabine, folinic acid, 5-FU
Outcomes
Primary Outcomes
overall survival
Time Frame: 1 year
Secondary Outcomes
- safety of treatment(1 year)
Study Sites (1)
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