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NCT00919282 Clinical Trial

Gemcitabine (GFF) in Patients With Pancreatic Cancer

Metastatic Pancreatic Cancer Clinical Trial

— GFF  

Official title:
A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00919282
Other study ID # CONKO 002 pilot
Secondary ID
Status Completed
Phase Phase 2
First received June 9, 2009
Last updated June 11, 2009
Start date September 1997
Est. completion date December 2002

Study information
Verified date June 2009
Source CONKO-Studiengruppe
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics CommissionGermany: Federal Institute for Drugs and Medical DevicesGermany: Federal Ministry of Education and Research
Study type Interventional

Clinical Trial 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).

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 information / eligibility
Status Completed
Enrollment 78
Est. completion date December 2002
Est. primary completion date July 2000
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• gemcitabine, folinic acid, 5-FU
gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours

Locations
Country Name City State
Germany Universitätsmedizin Berlin Berlin

Sponsors (2)
Lead Sponsor Collaborator
CONKO-Studiengruppe Eli Lilly and Company

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary overall survival 1 year No
Secondary safety of treatment 1 year Yes
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