NCT00350961

Brief Summary

In Denmark approximately 200 new cases of cholangiocarcinoma are diagnosed every year. No standard treatment exists for patients with advanced cholangiocarcinoma, and improved systemic treatments are needed. Duplets of gemcitabine, oxaliplatin and capecitabine have been evaluated in various cancers and several different regimens are well tolerated and active, especially in upper gastrointestinal cancers, exocrine pancreatic cancer and non-small cell lung cancer. The triplet combination of these agents has not been studied, but a triplet combination of gemcitabine, oxaliplatin and 5-FU infusion has been evaluated in a phase I study. Bi-weekly combination of gemcitabine and oxaliplatin has proven active and tolerable and warrants further study. In addition, fixed dose rate infusion of gemcitabine has shown interesting as the ability of mononuclear cells to accumulate gemcitabine triphosphate during therapy seems to be saturable. We propose a phase I-II study of a bi-weekly schedule of gemcitabine, oxaliplatin and capecitabine. This regimen could be feasible in an out-patients setting. The phase I part is a standard dose escalation study for patients with solid tumors. In the phase II part the recommended dose is studied in patients with advanced cholangiocarcinoma.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
39

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jun 2004

Typical duration for phase_1

Geographic Reach
1 country

2 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

June 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

July 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 11, 2006

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2008

Completed
Last Updated

August 26, 2008

Status Verified

August 1, 2008

First QC Date

July 10, 2006

Last Update Submit

August 25, 2008

Conditions

Cholangiocarcinoma

Keywords

CholangiocarcinomaFixed dose rateGemcitabineOxaliplatinCapecitabine

Outcome Measures

Primary Outcomes (1)

  • Response

Secondary Outcomes (3)

  • Safety

  • Time to progression

  • SUrvival

Interventions

GemcitabineDRUG
OxaliplatinDRUG
CapecitabineDRUG

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Histologically proven intra- or extrahepatic cholangiocarcinoma, papilla of the Vater or gallbladder carcinoma.
  • PS 0-2
  • Age 18-75
  • Life expectancy \> 12 weeks
  • Normal bone marrow function (neutrophiles \> 1,5 x 109/l and platelets \> 100 x 109/l)
  • Bilirubin \< 1,5 x UNL
  • Transaminases \< 3 x UNL
  • Normal renal function, Cr-EDTA clearance \> 50 ml/min
  • No known DPD-deficiency
  • No neuropathy
  • No uncontrolled, severe concurrent medical disease
  • Signed informed consent

You may not qualify if:

  • Uncontrolled, severe concurrent medical disease
  • Prior malignancy during the last 5 years, except for non-melanoma skin cancer and carcinoma in situ cervix uteri.
  • Allergy to gemcitabine, oxaliplatin or capecitabine
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet

Copenhagen, 2100, Denmark

Location

Vejle Sygehus

Vejle, 7100, Denmark

Location

MeSH Terms

Conditions

Cholangiocarcinoma

Interventions

GemcitabineOxaliplatinCapecitabine

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms

Intervention Hierarchy (Ancestors)

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

Study Officials

  • Ulrik Lassen, MD., PH.D.

    Rigshospitalet, Dept. of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 10, 2006

First Posted

July 11, 2006

Study Start

June 1, 2004

Study Completion

February 1, 2008

Last Updated

August 26, 2008

Record last verified: 2008-08

Locations

DK(2)