NCT00690300

Brief Summary

The purpose of this study is to test a combination-therapy of oxaliplatin and docetaxel in patients with metastatic or locally advanced adenocarcinoma of the pancreas after failure of a palliative first line therapy.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
44

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jan 2008

Typical duration for phase_2

Geographic Reach
1 country

5 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 2, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 4, 2008

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 3, 2010

Status Verified

January 1, 2010

Enrollment Period

2.9 years

First QC Date

June 2, 2008

Last Update Submit

March 2, 2010

Conditions

Pancreas Neoplasms

Keywords

adenocarcinoma of the pancreaspancreatic cancerpancreas carcinomaadvanced pancreatic cancermetastatic pancreatic cancersecond linepalliativeOxaliplatinDocetaxelTaxotereEloxatinCancer of pancreasPancreas cancer

Outcome Measures

Primary Outcomes (1)

  • tumor response

    12/2009 and end of the study 12/2010

Secondary Outcomes (5)

  • progression free survival

    12/2009 and end of study 12/2010

  • overall survival

    12/2009 and end of study 12/2010

  • Questionnaire for quality of life

    every three weeks

  • Questionnaire for clinical Benefit

    every week

  • toxicity / safety

    every week

Interventions

DocetaxelDRUG

75 mg/m2 IV on day 1 of each 22 day cycle

Also known as: Taxotere
OxaliplatinDRUG

80 mg/m2 IV on day 2 of each 22 day cycle

Also known as: Eloxatin

Eligibility Criteria

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

You may qualify if:

  • Dated and signed informed concent
  • Histologically or cytologically proven metastatic or locally advanced adenocarcinoma of the exocrine pancreas (stadium UICC III/IV)
  • Presence of at least one measurable (according to RECIST criteria) marker lesion (primary tumor or metastasis) outside of an area that was previously subjected to radiation therapy
  • Failure of a palliative first line therapy of a metastatic or locally advanced adenocarcinoma of the exocrine pancreas due to: Progress within 3 months after a first-line therapy Discontinuation of a first-line therapy due to toxicity
  • Age \>= 18 years
  • Karnofsky index \> 60%
  • Expected live span \> 12 weeks
  • Sufficient bone marrow reserve: Granulocytes \>= 1.5 x 109/L and Platelets \>= 100 x 109/L and Hemoglobin \>= 9 g/L
  • Serum Bilirubin \< 2 x upper normal limit or 2.5 x upper normal limit in case of hepatic metastasis (biliary drainage allowed)
  • AST/ALT \< 2.5 x upper normal limit

You may not qualify if:

  • Pregnancy or lactation
  • Patients able to reproduce that do not adhere to strict contraception
  • Presence of brain metastasis
  • Severe, uncontrolled infection
  • Preexisting peripheral neuropathy \> grade I
  • Preexisting severe illnesses such as unstable coronary artery disease or uncontrolled cardiac arrhythmia
  • Justified disbelief in the compliance of the patient
  • Parallel participation in another clinical trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Städtische Kliniken Esslingen

Esslingen am Neckar, Baden-Wurttemberg, 73730, Germany

RECRUITING

Klinikum Schwäbisch Gmünd

Mutlangen, Baden-Wurttemberg, 73557, Germany

RECRUITING

Universitätsklinikum Ulm Klinik für Innere Medizin I

Ulm, Baden-Wurttemberg, 89081, Germany

RECRUITING

Universitätsklinikum Giessen und Marburg GmbH

Marburg, Hesse, 35043, Germany

RECRUITING

Klinik und Poliklinik für Innere Medizin I / Universitätsklinikum Halle

Halle, 06097, Germany

RECRUITING

Related Publications (1)

  • Ettrich TJ, Perkhofer L, von Wichert G, Gress TM, Michl P, Hebart HF, Buchner-Steudel P, Geissler M, Muche R, Danner B, Kachele V, Berger AW, Guthle M, Seufferlein T. DocOx (AIO-PK0106): a phase II trial of docetaxel and oxaliplatin as a second line systemic therapy in patients with advanced pancreatic ductal adenocarcinoma. BMC Cancer. 2016 Jan 15;16:21. doi: 10.1186/s12885-016-2052-4.

    PMID: 26772812DERIVED

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

DocetaxelOxaliplatin

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesCoordination Complexes

Study Officials

  • Thomas Seufferlein, Prof. Dr.

    Universitätsklinikum Halle / Klinik für Innere Medizin I

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Thomas Seufferlein, Prof. Dr.

CONTACT

49-345-5572661thomas.seufferlein@medizin.uni-halle.de

Goetz von Wichert, PD Dr.

CONTACT

49-731-500-44748goetz.wichert@uniklinik-ulm.de

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 2, 2008

First Posted

June 4, 2008

Study Start

January 1, 2008

Primary Completion

December 1, 2010

Study Completion

December 1, 2010

Last Updated

March 3, 2010

Record last verified: 2010-01

Locations

DE(5)