Gemcitabine (GFF) in Patients With Pancreatic Cancer

NCT ID: NCT00919282

Last Updated: 2009-06-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

1997-09-30

Study Completion Date

2002-12-31

Brief Summary

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The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).

Detailed Description

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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.

Conditions

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Metastatic Pancreatic Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Gemcitabine/folinic acid/5-FU

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

Group Type EXPERIMENTAL

gemcitabine, folinic acid, 5-FU

Intervention Type DRUG

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

Interventions

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gemcitabine, folinic acid, 5-FU

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

Intervention Type DRUG

Other Intervention Names

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gemzar oncofolic 5-fu

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eli Lilly and Company

INDUSTRY

Sponsor Role collaborator

CONKO-Studiengruppe

OTHER

Sponsor Role lead

Responsible Party

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Universitätsmedizin Berlin

Principal Investigators

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helmut oettle, MD

Role: PRINCIPAL_INVESTIGATOR

CONKO-Studiengruppe

Locations

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Universitätsmedizin Berlin

Berlin, State of Berlin, Germany

Site Status

Countries

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Germany

Other Identifiers

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CONKO 002 pilot

Identifier Type: -

Identifier Source: org_study_id

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