We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Gemcitabine (GFF) in Patients With Pancreatic Cancer (GFF)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00919282
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : June 12, 2009
Information provided by:

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).

Condition or disease Intervention/treatment Phase
Metastatic Pancreatic Cancer Drug: gemcitabine, folinic acid, 5-FU Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.
Study Start Date : September 1997
Primary Completion Date : July 2000
Study Completion Date : December 2002

Arms and Interventions

Arm Intervention/treatment
Experimental: Gemcitabine/folinic acid/5-FU
Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²
Drug: gemcitabine, folinic acid, 5-FU
gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours
Other Names:
  • gemzar
  • oncofolic
  • 5-fu

Outcome Measures

Primary Outcome Measures :
  1. overall survival [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. safety of treatment [ Time Frame: 1 year ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00919282

Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
Eli Lilly and Company
Principal Investigator: helmut oettle, MD CONKO-Studiengruppe
More Information

Additional Information:
Responsible Party: CONKO-Studiengruppe, Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00919282     History of Changes
Other Study ID Numbers: CONKO 002 pilot
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by CONKO-Studiengruppe:
pancreatic cancer

Additional relevant MeSH terms:
Pancreatic Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Endocrine Gland Neoplasms
Digestive System Diseases
Pancreatic Diseases
Endocrine System Diseases
Folic Acid
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Protective Agents
Vitamin B Complex
Growth Substances