NCT00744640

Brief Summary

Gemcitabine is the mainstay of palliative chemotherapy for patients with advanced pancreatic cancer (APC). Recent randomized trials have shown increased clinical benefit with the addition of oxaliplatin and prolonged median survival with the addition of capecitabine to gemcitabine. Gemcitabine, capecitabine and oxaliplatin are 3 newer, well tolerated anticancer drugs with mild and non-overlapping toxicity profiles. We therefore propose a dose-finding and safety study of the triple combination gemcitabine, capecitabine and oxaliplatin in patients with APC (Phase I part), followed by a phase II part to assess preliminary efficacy of this triple combination.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Oct 2005

Longer than P75 for phase_1

Geographic Reach
1 country

8 active sites

Status
completed

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

October 1, 2005

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

August 29, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 1, 2008

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

January 12, 2010

Status Verified

January 1, 2010

Enrollment Period

3.3 years

First QC Date

August 29, 2008

Last Update Submit

January 11, 2010

Conditions

Locally Advanced Pancreatic CancerMetastatic Pancreatic Cancer

Keywords

advanced pancreatic cancerpalliative chemotherapyfirst-line therapycapecitabineoxaliplatingemcitabinedose-finding studyPhase II

Outcome Measures

Primary Outcomes (1)

  • Response rate

    6 weeks

Secondary Outcomes (1)

  • Progression-free survival and overall survival

    3 months

Study Arms (1)

single

EXPERIMENTAL

single arm study with triple combination chemotherapy

Drug: gemcitabine, oxaliplatin, capecitabine

Interventions

gemcitabine, oxaliplatin, capecitabineDRUG

gemcitabine day 1 and 8, oxaliplatin day 1, capecitabine days 1-14, q3weeks

single

Eligibility Criteria

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

You may qualify if:

  • Cytologically or histologically confirmed adenocarcinoma of the exocrine pancreas
  • Disease non-resectable and locally advanced or metastatic
  • Measurable disease or evaluable disease i.e. tumor marker CA19-9 at baseline ≥ 1.5 x upper limit of normal (ULN)
  • Age \>18 years
  • Karnofsky performance status ≥ 60%
  • Life expectancy of at least 3 months
  • Written informed consent
  • Willing and able to comply with the protocol for the duration of the study

You may not qualify if:

  • Prior chemotherapy for pancreatic cancer
  • Known CNS metastases at the time of enrollment
  • Neutrophil count ≤ 1.5 x109/l, platelet count ≤100 x109/l, hemoglobin ≤ 10g/dl
  • Serum creatinine \> 1.25 x ULN
  • ASAT, ALAT and alkaline phosphatase \> 2.5 ULN or \> 5 ULN in the presence of liver metastasis, Bilirubin \> 1.5 ULN (after treatment of obstructive jaundice eg. stent)
  • Pregnant or breast feeding women (women of childbearing potential must have a negative pregnancy test at baseline)
  • Men and women of reproductive potential who are not using an effective method of contraception
  • Clinically significant cardiac disease (NYHA III-IV) or myocardial infarction within the last 12 months
  • Neurological disease with dys-/paraesthesias \> grade 1 according to NCI CTC
  • Any serious concomitant disorder incompatible with the trial (in the judgement of the investigator)
  • Psychiatric disability thought to be clinically significant in the opinion of the investigator precluding informed consent or interfering with compliance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Cantonal Hospital Bruderholz

Bruderholz, Basel-Landschaft, Switzerland

Location

Cantonal Hospital Liestal

Liestal, Basel-Landschaft, Switzerland

Location

St. Clara Hospital

Basel, Switzerland

Location

University Hospital Basel

Basel, Switzerland

Location

Cantonal Hospital Lucerne

Lucerne, Switzerland

Location

City Hospital Triemli

Zurich, Switzerland

Location

Oncocenter Hirslanden

Zurich, Switzerland

Location

University Hospital

Zurich, Switzerland

Location

MeSH Terms

Conditions

Pancreatic Neoplasms

Interventions

GemcitabineOxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Study Officials

  • Viviane Hess, MD

    University Hospital, Basel, Switzerland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 29, 2008

First Posted

September 1, 2008

Study Start

October 1, 2005

Primary Completion

February 1, 2009

Study Completion

December 1, 2009

Last Updated

January 12, 2010

Record last verified: 2010-01

Locations

CH(8)