Back to resultsGemcitabine (GFF) in Patients With Pancreatic Cancer (GFF)
Primary Purpose
Metastatic Pancreatic Cancer
Status
Completed
Phase
Phase 2
Locations
Germany
Study Type
Interventional
Intervention
gemcitabine, folinic acid, 5-FU
Sponsored by
About this trial
This is an interventional treatment trial for Metastatic Pancreatic Cancer focused on measuring pancreatic cancer, gemcitabine, combination
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
Sites / Locations
- Universitätsmedizin Berlin
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Gemcitabine/folinic acid/5-FU
Arm Description
Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²
Outcomes
Primary Outcome Measures
overall survival
Secondary Outcome Measures
safety of treatment
Full Information
NCT ID
NCT00919282
First Posted
June 9, 2009
Last Updated
June 11, 2009
Sponsor
CONKO-Studiengruppe
Collaborators
Eli Lilly and Company
1. Study Identification
Unique Protocol Identification Number
NCT00919282
Brief Title
Gemcitabine (GFF) in Patients With Pancreatic Cancer
Acronym
GFF
Official Title
A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
September 1997 (undefined)
Primary Completion Date
July 2000 (Actual)
Study Completion Date
December 2002 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
CONKO-Studiengruppe
Collaborators
Eli Lilly and Company
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Pancreatic Cancer
Keywords
pancreatic cancer, gemcitabine, combination
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
78 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Gemcitabine/folinic acid/5-FU
Arm Type
Experimental
Arm Description
Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²
Intervention Type
Drug
Intervention Name(s)
gemcitabine, folinic acid, 5-FU
Other Intervention Name(s)
gemzar, oncofolic, 5-fu
Intervention Description
gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours
Primary Outcome Measure Information:
Title
overall survival
Time Frame
1 year
Secondary Outcome Measure Information:
Title
safety of treatment
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
helmut oettle, MD
Organizational Affiliation
CONKO-Studiengruppe
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
12. IPD Sharing Statement
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Gemcitabine (GFF) in Patients With Pancreatic Cancer
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