NCT00919282

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
78

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 1997

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1997

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2000

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2002

Completed
6.5 years until next milestone

First Submitted

Initial submission to the registry

June 9, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 12, 2009

Completed
Last Updated

June 12, 2009

Status Verified

June 1, 2009

Enrollment Period

2.8 years

First QC Date

June 9, 2009

Last Update Submit

June 11, 2009

Conditions

Metastatic Pancreatic Cancer

Keywords

pancreatic cancergemcitabinecombination

Outcome Measures

Primary Outcomes (1)

  • overall survival

    1 year

Secondary Outcomes (1)

  • safety of treatment

    1 year

Study Arms (1)

Gemcitabine/folinic acid/5-FU

EXPERIMENTAL

Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²

Drug: gemcitabine, folinic acid, 5-FU

Interventions

gemcitabine, folinic acid, 5-FUDRUG

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

Also known as: gemzar, oncofolic, 5-fu
Gemcitabine/folinic acid/5-FU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • histological proved pancreatic cancer
  • inoperable disease
  • informed consent
  • adequate bone marrow reserve

You may not qualify if:

  • under 18 years
  • brain metastasis
  • lactating woman
  • life expectancy under 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätsmedizin Berlin

Berlin, State of Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineLeucovorinFluorouracil

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingFormyltetrahydrofolatesTetrahydrofolatesFolic AcidPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingCoenzymesEnzymes and CoenzymesUracilPyrimidinones

Study Officials

  • helmut oettle, MD

    CONKO-Studiengruppe

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 9, 2009

First Posted

June 12, 2009

Study Start

September 1, 1997

Primary Completion

July 1, 2000

Study Completion

December 1, 2002

Last Updated

June 12, 2009

Record last verified: 2009-06

Locations

DE(1)