Metastatic Pancreatic CancerPhase 2GFFNCT00919282
Gemcitabine (GFF) in Patients With Pancreatic Cancer
A Phase 2 study testing gemcitabine, folinic acid, 5-FU in people with Metastatic Pancreatic Cancer, run by CONKO-Studiengruppe at 1 site in Germany.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Pancreatic Cancer
- What is being tested?
- gemcitabine, folinic acid, 5-FU
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteGermany
- Study dates
- Sep 1997to Dec 2002
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- histological proved pancreatic cancer
- inoperable disease
- informed consent
- adequate bone marrow reserve
Who cannot join
- under 18 years
- brain metastasis
- lactating woman
- life expectancy under 3 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.
The purpose of this study is to examine the efficacy and safety of the drug combination GFF in patients with advanced pancreatic cancer (APC).
Read the 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.
- Conditions
- Metastatic Pancreatic Cancer
- Being tested
- gemcitabine, folinic acid, 5-FU
- Keywords
- pancreatic cancer, gemcitabine, combination
- Medical subject headings
- Pancreatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
gemcitabine, folinic acid, 5-FUDrug
Also called gemzar, oncofolic, 5-fu
gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours
| Study group | Role | What they receive |
|---|---|---|
| Gemcitabine/folinic acid/5-FU | Experimental | Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m² Receives: Drug: gemcitabine, folinic acid, 5-FU |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall survival
Measured: 1 year
Secondary outcomes (1)
safety of treatment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2009 (estimated)
- Study startSep 1997
- Primary completionJul 2000
- Study completionDec 2002
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Pancreatic CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- CONKO-Studiengruppe
- Sponsor type
- University, hospital or other
- Collaborators
- Eli Lilly and Company
- Investigators
- helmut oettle, MD, Principal investigator, CONKO-Studiengruppe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00919282
- Sponsor's protocol ID
- CONKO 002 pilot
- Acronym
- GFF
- Status last verified
- Jun 2009
- First submitted
- 9 Jun 2009
- Last updated
- 12 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.
- ClinicalTrials.gov ID
- NCT00919282
- Acronym / sponsor ID
- GFF / CONKO 002 pilot
- Conditions
- Metastatic Pancreatic Cancer
- Keywords
- pancreatic cancer, gemcitabine, combination
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 78 participants (actual)
- Lead sponsor
- CONKO-StudiengruppeUniversity, hospital or other
- Collaborators
- Eli Lilly and Company
- Study start
- Sep 1997
- Primary completion
- Jul 2000 (actual)
- Study completion
- Dec 2002 (actual)
- First posted
- 12 Jun 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gemcitabine/folinic acid/5-FU | Experimental | Drug: gemcitabine, folinic acid, 5-FUGemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m² |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- histological proved pancreatic cancer
- inoperable disease
- informed consent
- adequate bone marrow reserve
Key exclusion criteria (4 listed)
- under 18 years
- brain metastasis
- lactating woman
- life expectancy under 3 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| gemcitabine, folinic acid, 5-FUAlso: gemzar, oncofolic, 5-fugemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours | Drug | Gemcitabine/folinic acid/5-FU |
Primary outcome
overall survival
Time frame: 1 year
1 secondary outcome
safety of treatment
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
helmut oettle, MD principal investigator
CONKO-Studiengruppe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing gemcitabine, folinic acid, 5-FU in people with Metastatic Pancreatic Cancer, run by CONKO-Studiengruppe at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
overall survival (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2009.