Gemcitabine (GFF) in Patients With Pancreatic Cancer | NCT00919282

Studies
Gemcitabine (GFF) in Patients With Pancreatic Cancer

NCT00919282

Sponsor

CONKO-Studiengruppe

Status

Completed

Last Update Posted

Jun 12, 2009Estimated

Enrollment

78Actual

Phase

Phase 2

Conditions

Metastatic Pancreatic Cancer

Interventions

gemcitabine, folinic acid, 5-FU

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1997

Primary Completion Date

Jul 2000Actual

Completion Date

Dec 2002Actual

First Submitted Date

Jun 9, 2009

First Submission Date that Met QC Criteria

Jun 11, 2009

First Posted Date

Jun 12, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 11, 2009

Last Update Posted Date

Jun 12, 2009Estimated

Name	Class
Eli Lilly and Company	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

78Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Gemcitabine/folinic acid/5-FU	Experimental	Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²	Drug: gemcitabine, folinic acid, 5-FU

Interventions

Name	Type	Description	Arm Group Labels	Other Names
gemcitabine, folinic acid, 5-FU	Drug	gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours	Gemcitabine/folinic acid/5-FU

Measure	Description	Time Frame
overall survival		1 year

Measure	Description	Time Frame
safety of treatment		1 year

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
helmut oettle, MD	CONKO-Studiengruppe	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätsmedizin Berlin		Berlin	State of Berlin	13353	Germany

Condition Browse Module

MeSH Terms

ID	Term
D010190	Pancreatic Neoplasms

Ancestor Terms

ID	Term
D004067	Digestive System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D004701	Endocrine Gland Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000093542	Gemcitabine
D002955	Leucovorin
D005472	Fluorouracil

Ancestor Terms

ID	Term
D006571	Heterocyclic Compounds
D003841	Deoxycytidine
D003562	Cytidine
D011741	Pyrimidine Nucleosides

Browse Leaves

Not provided

Browse Branches

Not provided