Gemcitabine (GFF) in Patients With Pancreatic Cancer

This study has been completed.
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by:
CONKO-Studiengruppe
ClinicalTrials.gov Identifier:
NCT00919282
First received: June 9, 2009
Last updated: June 11, 2009
Last verified: June 2009
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • safety of treatment [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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:
No publications provided

Responsible Party: CONKO-Studiengruppe, Universitätsmedizin Berlin
ClinicalTrials.gov Identifier: NCT00919282     History of Changes
Other Study ID Numbers: CONKO 002 pilot
Study First Received: June 9, 2009
Last Updated: June 11, 2009
Health Authority: Germany: Ethics Commission
Germany: Federal Institute for Drugs and Medical Devices
Germany: Federal Ministry of Education and Research

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
Fluorouracil
Gemcitabine
Leucovorin
Folic Acid
Levoleucovorin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Antidotes
Protective Agents
Hematinics
Hematologic Agents

ClinicalTrials.gov processed this record on July 24, 2014