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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Pancreatic Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

overall survival

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

helmut oettle, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

CONKO-Studiengruppe

Authority:

Germany: Ethics Commission

Study ID:

CONKO 002 pilot

NCT ID:

NCT00919282

Start Date:

September 1997

Completion Date:

December 2002

Related Keywords:

  • Metastatic Pancreatic Cancer
  • pancreatic cancer
  • gemcitabine
  • combination
  • Pancreatic Neoplasms

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