NCT00786058

Brief Summary

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.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2008

Completed
Last Updated

June 15, 2009

Status Verified

June 1, 2009

First QC Date

November 4, 2008

Last Update Submit

June 12, 2009

Conditions

Pancreatic Cancer

Keywords

refractory pancreatic cancergemcitabinephase IIIsecond line

Interventions

OFF in experimental armDRUG

OFF was given according to a six week cycle. FA (500 mg/m2 , 0.5h, i.v.) and 5-FU (2,600 mg/m2, 24-hour, i.v.) were administered on days 1, 8, 15, and 22. Oxaliplatin (85 mg/m2 , 2-4 h, i.v.) was administered directly before FA/ 5-FU on days 8 and 22.

Also known as: Eloxatin, Calciumfolinat, 5-Fluorouracil

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Oettle 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: 24982456DERIVED

Related Links

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

OxaliplatinFluorouracil

Condition Hierarchy (Ancestors)

Digestive System NeoplasmsNeoplasms by SiteNeoplasmsEndocrine Gland NeoplasmsDigestive System DiseasesPancreatic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Coordination ComplexesOrganic ChemicalsUracilPyrimidinonesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Helmut Oettle, PD

    CONKO Study Group

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
expanded access
Sponsor Type
OTHER

Study Record Dates

First Submitted

November 4, 2008

First Posted

November 5, 2008

Last Updated

June 15, 2009

Record last verified: 2009-06