Clinical trial · Expanded Access
A Phase III Second Line Trial in Advanced Pancreatic Cancer CONKO 003
A Phase III Second Line Trial of Patients With Gemcitabine Resistant Advanced Pancreatic Cancer (CONKO-003)
NCT00786058CI-TRIAL-00002381approved for marketingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to compare best supportive care plus oxaliplatin/ folinic acid/ 5-FU versus best supportive alone in patients with gemcitabine refractory pancreatic cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pancreatic Cancer | Malignant Pancreatic Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| OFF in experimental arm | Drug | — | UNRESOLVED |
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with histologically or cytologically confirmed metastatic pancreatic adenocarcinoma that had progressed during first line gemcitabine therapy were eligible for inclusion in the study. Other inclusion criteria were: * Age \> 18 years * Karnofsky performance status \> 70% * Bidimensionally measurable reference lesion, adequate laboratory values for hematology (white blood cell \[WBC\] count \> 3.5´109/L, platelet count \> 100´109/L), renal function (creatine clearance \> 30 ml/min) and hepatic function (aspartate aminotransferase \[AST\] or alanine aminotransferase \[ALT\] \< 2.5 ´ upper normal limit \[UNL\] and in the case of liver metastasis \< 5 x UNL) * As well as controlled pain Exclusion Criteria: * Patients were excluded from the study if they had any severe concurrent medical condition interfering with planned therapy, serious cardiac disease, sensory/ motor neuropathy \> grade 2 or had previous or current malignancies at other origin; besides, pregnant or lactating women were excluded. * All patients provided written informed consent.
References
Publications (1)
- DERIVEDOettle H, Riess H, Stieler JM, Heil G, Schwaner I, Seraphin J, Gorner M, Molle M, Greten TF, Lakner V, Bischoff S, Sinn M, Dorken B, Pelzer U. Second-line oxaliplatin, folinic acid, and fluorouracil versus folinic acid and fluorouracil alone for gemcitabine-refractory pancreatic cancer: outcomes from the CONKO-003 trial. J Clin Oncol. 2014 Aug 10;32(23):2423-9. doi: 10.1200/JCO.2013.53.6995. Epub 2014 Jun 30. PMID 24982456