---
title: Gemcitabine (GFF) in Patients With Pancreatic Cancer
nct_id: NCT00919282
overall_status: COMPLETED
phase: PHASE2
sponsor: CONKO-Studiengruppe
study_type: INTERVENTIONAL
primary_condition: Metastatic Pancreatic Cancer
countries: Germany
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT00919282.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT00919282"
ct_last_update_post_date: 2009-06-12
last_seen_at: "2026-05-12T06:10:58.984Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Gemcitabine (GFF) in Patients With Pancreatic Cancer

**Official Title:** A Multi Center Phase II Study of 5-Fluorouracil/ Folinic Acid Plus Gemcitabine in Patients With Advanced Pancreatic Cancer.

**NCT ID:** [NCT00919282](https://clinicaltrials.gov/study/NCT00919282)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 78
- **Lead Sponsor:** CONKO-Studiengruppe
- **Collaborators:** Eli Lilly and Company
- **Conditions:** Metastatic Pancreatic Cancer
- **Start Date:** 1997-09
- **Completion Date:** 2002-12
- **CT.gov Last Update:** 2009-06-12

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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
```

## Arms

- **Gemcitabine/folinic acid/5-FU** (EXPERIMENTAL) — Gemcitabine 1g/m² 5-FU 750mg/m² FS 500 mg/m²

## Interventions

- **gemcitabine, folinic acid, 5-FU** (DRUG) — gemcitabine 1g/m² - 30 minutes folinic acid 500mg/m² - 2 hours 5-FU 750mg/m² - over 24hours

## Primary Outcomes

- **overall survival** _(time frame: 1 year)_

## Secondary Outcomes

- **safety of treatment** _(time frame: 1 year)_

## Locations (1)

- Universitätsmedizin Berlin, Berlin, State of Berlin, Germany

## Recent Field Changes (last 30 days)

- `eligibility.sex` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.universitätsmedizin berlin|berlin|state of berlin|germany` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT00919282*  
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