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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00919282
First Posted: June 12, 2009
Last Update Posted: June 12, 2009
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.
Collaborator:
Eli Lilly and Company
Information provided by:
CONKO-Studiengruppe
  Purpose
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 Intervention Phase
Metastatic Pancreatic Cancer Drug: gemcitabine, folinic acid, 5-FU Phase 2

Study Type: Interventional
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by CONKO-Studiengruppe:

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

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

Enrollment: 78
Study Start Date: September 1997
Study Completion Date: December 2002
Primary Completion Date: July 2000 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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


Locations
Germany
Universitätsmedizin Berlin
Berlin, Germany, 13353
Sponsors and Collaborators
CONKO-Studiengruppe
Eli Lilly and Company
Investigators
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 Submitted: June 9, 2009
First Posted: June 12, 2009
Last Update Posted: June 12, 2009
Last Verified: June 2009

Keywords provided by CONKO-Studiengruppe:
pancreatic cancer
gemcitabine
combination

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